Category Archives: Medical Writing

The Role of AI & Machine Learning in Real-World Evidence Generation

Medical Devices, Medical Publishing, Medical Writing,

In the evolving era of healthcare, data is the foundation of informed decision-making. With the rise of Artificial Intelligence (AI) and Machine Learning (ML), real-world evidence (RWE) generation is undergoing a revolutionary transformation. AI-driven analytics empower researchers and healthcare professionals (HCPs) to extract meaningful insights from vast and complex datasets which ultimately improve patient outcomes and optimize treatment strategies.

The power of RWE in healthcare

AI and ML are playing a pivotal role in bridging the gap between controlled clinical trials and real-world clinical practices by enabling seamless synthesis and interpretation of diverse datasets. These technologies help in aligning clinical evidence with real-world treatment patterns and outcomes, making the data more applicable and impactful for regulatory documentation. Through automated data extraction, natural language processing, and real-time analytics, AI supports the creation of timely and compliant regulatory submissions that reflect real-world treatment efficacy and safety. In publication planning, ML can identify emerging data trends and prioritize high-impact topics, while AI-driven tools streamline manuscript generation and literature analysis. Additionally, in Health Economics and Outcomes Research (HEOR), AI enhances model precision by incorporating dynamic, real-world variables—leading to more robust cost-effectiveness and budget impact assessments that resonate with payers and policymakers.

How AI & ML transform RWE generation

  1. Data integration & processing

Healthcare data is often fragmented across multiple systems, making integration a major challenge. AI-driven algorithms efficiently harmonize disparate datasets, standardizing information from diverse sources such as:

  • EHRs: AI extracts relevant clinical information while maintaining patient privacy.
  • Wearable & sensor data: Continuous monitoring devices provide real-time insights into patient health trends.
  • Medical imaging & genomic data: AI enhances pattern recognition, enabling precision medicine approaches.
  1. Predictive analytics for better decision-making

ML models analyze historical patient data to predict outcomes, identify disease progression, and assess treatment efficacy. For example:

  • Early disease detection: AI models detect anomalies in imaging scans or lab results, enabling early intervention.
  • Treatment optimization: By analyzing patient responses to therapies, ML suggests tailored treatment plans, reducing trial-and-error approaches.
  • Risk stratification: AI helps classify patients based on risk factors, aiding in proactive disease management.
  1. Enhancing clinical trials & drug development

AI and ML streamline clinical research by:

  • Patient recruitment: Identifying eligible participants through automated data analysis.
  • Synthetic control arms: Using AI-generated patient models to simulate control groups, reducing the need for large trial populations.
  • Real-time monitoring: AI continuously tracks patient responses, adjusting protocols dynamically for optimal results.
  1. Improving pharmacovigilance & safety monitoring

Post-market drug surveillance benefits from AI’s ability to detect adverse events from vast datasets, including:

  • Social media & patient forums: AI scans digital discussions for emerging side effect patterns.
  • EHRs & claims data: Identifies unexpected adverse reactions across large patient populations.
  • Natural Language Processing (NLP): Extracts insights from unstructured physician notes and reports.

Real-world impact of AI & ML in RWE generation

AI-driven RWE applications are already making tangible improvements in healthcare:

  • Personalized medicine: AI enables the development of individualized treatment plans based on genetic, environmental, and lifestyle factors.
  • Chronic disease management: ML models predict disease exacerbations, prompting timely interventions.
  • Health policy & public health initiatives: AI-driven RWE informs regulatory decisions, optimizing healthcare resource allocation.

Challenges & Solutions in AI-Powered RWE Generation

Challenge Solution
Data privacy & security Implementing robust encryption and federated learning techniques.
Bias & algorithm transparency Ensuring diverse datasets and conducting regular audits to reduce biases.
Regulatory compliance Aligning AI applications with global data governance frameworks.
Interpretability of AI models Developing explainable AI (XAI) methods for better clinical adoption.

 

The future of AI in RWE

As AI and ML continue to advance, their role in RWE generation will expand, fostering

  • More efficient drug approvals: Regulatory bodies increasingly rely on AI-enhanced RWE to accelerate decision-making.
  • Improved patient-centric care: AI-powered insights enable more holistic, tailored treatment plans.
  • Greater integration with wearable tech: Continuous patient monitoring enhances real-time evidence collection.

Turacoz remain committed to scientific integrity, clear communication, and regulatory compliance. Our AI-enhanced approach to RWE documentation ensures that valuable real-world insights are effectively translated into actionable information for all stakeholders.

By combining medical writing expertise with advanced AI and ML capabilities, we help our clients transform complex real-world data into compelling evidence narratives that advance medical knowledge, support regulatory decisions, and ultimately improve patient care.

Are Real-World Studies Reliable? Addressing Bias & Data Quality Issues

Medical Devices, Medical Publishing, Medical Writing,

In an era where healthcare decisions are increasingly driven by data, real-world evidence (RWE) has become a crucial tool for assessing treatment effectiveness beyond controlled medical trials. Real-world data (RWD) provides insights into how medical interventions perform across diverse patient populations in routine practice. However, concerns regarding bias, data integrity, and regulatory compliance raise an important question: How reliable are real-world studies?

The Growing Importance of RWE

Unlike traditional clinical trials, which follow strict protocols and eligibility criteria, real-world studies rely on data from electronic health records (EHRs), insurance claims, patient registries, and even wearable devices. This shift allows researchers, policymakers, and healthcare professionals to evaluate the long-term safety, cost-effectiveness, and impact of treatments in real-world settings.

Medical affairs teams use RWE to support health economics research, inform market access strategies, and guide regulatory decision-making. However, ensuring the credibility of findings requires a proactive approach to addressing biases and enhancing data quality.

Common Biases in Real-world Studies

Real-world studies are vulnerable to multiple forms of bias, which can compromise their reliability:

  • Selection bias: Since real-world studies do not employ randomized patient selection, certain demographic or clinical groups may be overrepresented or underrepresented, leading to skewed results.
  • Confounding variables: Unlike randomized controlled trials (RCTs), real-world studies often lack mechanisms to isolate variables, making it difficult to establish causality.
  • Reporting bias: Incomplete or inconsistent data entry in electronic health records and insurance claims databases can introduce errors that affect study conclusions.
  • Publication bias: Studies with favorable outcomes are more likely to be published, creating an incomplete picture of a treatment’s true effectiveness.

Mitigating Bias in RWE

Several methodologies can help mitigate bias in RWE studies:

  1. Propensity score matching (PSM): This statistical technique matches patients with similar baseline characteristics to reduce confounding.
  2. Inverse probability weighting (IPW): A weighting method that adjusts for imbalances in patient characteristics, improving comparability.
  3. Sensitivity analyses: Conducting multiple analyses with different assumptions helps assess the robustness of findings.
  4. Use of linked datasets: Combining multiple data sources (e.g., EHRs, registries, and claims data) can improve data completeness and reduce missingness-related biases1.

Ensuring Data Quality in Real-world Studies

Improving the reliability of RWE requires stringent methodologies and advanced analytical tools. Strategies to enhance data quality include:

  • Systematic literature reviews: Conducting thorough literature reviews ensures that RWE studies incorporate all relevant data, reducing the risk of biased conclusions2.
  • Artificial intelligence in healthcare: AI-driven analytics can identify patterns, clean datasets, and account for missing variables, leading to more reliable insights3.
  • Standardized data collection: Implementing structured reporting systems across healthcare institutions ensures greater consistency and completeness in real-world data4.
  • Regulatory compliance: Adhering to guidelines set by regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) ensures that real-world studies meet rigorous scientific and ethical standards5.

The Role of Regulatory Compliance in RWE Reliability

To incorporate RWE into clinical decision-making, regulatory bodies have introduced stringent data governance frameworks. Ensuring compliance with Good Clinical Practice (GCP) and other regulations mitigates the risks associated with incomplete or biased data.

  • The FDA’s Real-World Evidence Framework establishes standards for assessing RWD quality, study design, and applicability in regulatory submissions6.
  • The EMA emphasizes transparency and reproducibility in RWE submissions, ensuring that studies meet the highest scientific standards7.

For example, the FDA approved Palbociclib (Ibrance) for male breast cancer based on RWE from claims and EHR data rather than traditional clinical trials8. This case highlights how high-quality RWE can inform regulatory decisions when RCTs are impractical.

Future Outlook: Combining RWE with Clinical Trials

While RCTs remain the gold standard for evaluating treatment efficacy, RWE plays a complementary role by providing insights into long-term safety, patient adherence, and economic impact. Integrating real-world data with traditional research methodologies can create a more comprehensive understanding of healthcare interventions.

Advancements in AI-driven analytics, real-time data integration, and digital health monitoring are improving the accuracy of RWE studies. Organizations are increasingly leveraging these technologies to refine data accuracy and eliminate bias9. By embracing the best practices in systematic literature review, regulatory compliance, and data validation, real-world studies can offer valuable insights that drive evidence-based healthcare decisions.

The Path Forward

RWE is a powerful tool in modern healthcare, but its reliability depends on addressing biases and ensuring data integrity. Implementing standardized methodologies, leveraging artificial intelligence, and adhering to regulatory standards can help unlock the full potential of real-world studies and effectively disseminate findings across the healthcare ecosystem.

References

  1. Schneeweiss S. Learning from big health care data. N Engl J Med. 2014;370(23):2161-3.
  2. Wang SV, Pinheiro S, Hua W, et al. STaRT-RWE: structured template for planning and reporting on the implementation of real-world evidence studies. BMJ 2021;372:m4856.
  3. Rajkomar A, Dean J, Kohane I. Machine learning in medicine. N Engl J Med. 2019;380(14):1347-58.
  4. FDA. Real-world evidence: what is it and what can it tell us? [Internet]. 2023 [cited Feb 27, 2025]. Available from: https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence
  5. European Medicines Agency. Real-world evidence in regulatory decision-making [Internet]. 2022 [cited Feb 27, 2025]. Available from: https://www.ema.europa.eu/en/human-regulatory/post-authorisation/real-world-evidence
  6. US FDA. Framework for FDA’s real-world evidence program [Internet]. 2018 [cited Feb 27, 2025]. Available from: https://www.fda.gov/media/120060/download
  7. European Medicines Agency. Guideline on good pharmacovigilance practices (GVP) [Internet]. 2021 [cited Feb 27, 2025]. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices_en.pdf
  8. US FDA. FDA approves Ibrance for male breast cancer based on real-world evidence [Internet]. 2019 [cited Feb 27, 2025]. Available from: https://www.fda.gov/news-events/press-announcements/fda-approves-ibrance-male-breast-cancer-based-real-world-evidence
  9. Corrigan-Curay J, Sacks L, Woodcock J. Real-world evidence and regulatory decision making: where are we now? Clin Pharmacol Ther. 2018;104(5):822-9.

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The Role of Medical Science Liaisons in Educating Physicians on Colorectal Cancer Advances

Medical Devices, Medical Publishing, Medical Writing,

Colorectal cancer (CRC) is the third most commonly diagnosed form of cancer globally and is the second most common cancer-related cause of death worldwide.1,2 This makes CRC a major public health issue due to the great economic burden it places on countries. There is significant progress in screening, diagnosis, and therapy for CRC at present; however, prognosis is poor, and there are challenges.2 With rapid advancements in treatment, staying updated on new therapeutic developments is crucial. Medical Science Liaisons (MSLs) play a vital role in bridging the gap between pharmaceutical companies and healthcare professionals (HCPs) by providing scientific expertise, facilitating medical education, and ensuring the exchange of accurate, up-to-date clinical data and therapeutic guidelines.3

The growing importance of MSLs in oncology

MSLs are highly trained scientific professionals, often with advanced degrees in medicine, pharmacy, or life sciences, and are key members of the medical Affairs teams of pharmaceutical companies.3 They serve as a critical link between the pharmaceutical industry and the medical community, aiding in informed decision-making, fostering collaborations, and enhancing patient care.4

In oncology, where the treatment landscape evolves rapidly, MSLs play a key role in equipping physicians with the knowledge necessary to optimize patient care.

How MSLs keep physicians updated on CRC research

Colorectal cancer treatment has witnessed major advancements in recent years, including targeted therapies, immunotherapies, precision medicine and biomarker-based treatment, antibody-drug conjugate therapy, and novel chemotherapy.5 MSLs ensure that physicians stay informed on these innovations in the following ways:

  1. Providing clinical insights

MSLs interpret and communicate complex clinical trial data, helping physicians understand the latest scientific breakthroughs and how new therapies compare with existing treatments in terms of efficacy, safety, and patient outcomes.6 Thus, MSLs serve as a bridge between the industry and HCPs or key opinion leaders (KOLs), facilitating a two-way exchange of scientific and clinical information. By keeping KOLs informed about the latest industry developments, MSLs help save their valuable time.4

  1. Explaining mechanisms of action

With the rise of precision medicine, understanding the molecular mechanisms of novel drugs is crucial. MSLs educate physicians on how therapies, such as immune checkpoint inhibitors, monoclonal antibodies, and combination regimen, work at a molecular level.

  1. Navigating treatment guidelines

Organizations like the National Comprehensive Cancer Network (NCCN) and the American Society of Clinical Oncology (ASCO) frequently update treatment guidelines. MSLs assist physicians in integrating these changes into clinical practice, ensuring adherence to the most recent guidelines.

  1. Facilitating real-world data insights

Beyond clinical trials, real-world evidence plays a crucial role in assessing long-term treatment effectiveness and improving medical treatment.7 MSLs provide valuable insights into patient responses, adverse event management, and emerging real-world trends.

How MSLs bridge research and clinical practice

One of the major challenges in oncology is translating scientific research into practical, patient-centered care. MSLs address this challenge by:

  1. Conducting peer-to-peer educational programs

MSLs organize advisory boards, roundtable discussions, and one-on-one meetings with KOLs to discuss recent advancements in the therapeutic area and their implications for clinical practice.  MSLs gather insights from KOLs and help in guiding research and product development for pharmaceutical and biotechnology companies.

  1. Facilitating clinical trials

Oncologists often collaborate with pharmaceutical companies to enroll patients in clinical trials. MSLs help identify suitable studies, clarify eligibility criteria, and provide trial-related updates to oncologists.

  1. Providing medical education resources

From whitepapers to webinars, MSLs curate educational content tailored to the needs of oncologists, ensuring they have access to reliable and relevant information.

  1. Fostering multidisciplinary collaboration in CRC treatment

Colorectal cancer management requires a multidisciplinary approach, involving medical specialists such as medical oncologists, surgical oncologists, radiologists, gastroenterologists, radiation oncologists, and pathologists.8 MSLs play a crucial role in fostering collaboration among these specialties by:

  • Encouraging interdisciplinary discussions on treatment sequencing and combination strategies.
  • Addressing concerns related to emerging therapies, such as side effect management and patient selection criteria.
  • Ensuring consistent communication between pharmaceutical companies and medical institutions to align treatment advancements with real-world patient needs.

Call to action: Recognizing the impact of MSLs in oncology

The Colorectal Cancer Awareness Month serves as a timely reminder to recognize and appreciate the invaluable contributions of MSLs in the fight against CRC. Turacoz proudly acknowledges and values the critical role MSLs play in advancing care and driving impact in the battle against CRC. Their expertise not only advances physician education but also enhances patient outcomes by ensuring that the latest medical innovations are seamlessly integrated into clinical practice.

By championing the role of MSLs, we can bridge the gap between research and real-world care, ensuring every patient with CRC receives the best treatment possible.

 

References

  1. Klimeck L, Heisser T, Hoffmeister M, et al. Colorectal cancer: A health and economic problem. Best Practice & Research Clinical Gastroenterology. 2023 Oct 1;66:101839.
  2. Fadlallah H, El Masri J, Fakhereddine H, et al. Colorectal cancer: Recent advances in management and treatment. World journal of clinical oncology. 2024 Sep 24;15(9):1136.
  3. Chen J, Burns G, Kelly C, Vanderhoef D, Johnson J. Medical Science Liaisons: A Guide for Advanced Practice Registered Nurses. The Journal for Nurse Practitioners. 2024 Nov 1;20(10):105211.
  4. García García C, Riosalido Montero M, Sastre V, González del Castillo A, Matesanz Marín A. The medical science liaison role in Spain: Opinion of the commercial department personnel. Therapeutic Innovation & Regulatory Science. 2023 Sep;57(5):1030-9.
  5. Alese OB, Wu C, Chapin WJ, et al. Update on emerging therapies for advanced colorectal cancer. American Society of Clinical Oncology Educational Book. 2023 May;43:e389574.
  6. Theron P, Britland M, Holder D, Ikeda Y, Rewers RF, Tiku A. Promoting best practices for medical science liaisons position statement from the APPA, IFAPP, MAPS and MSLS. Therapeutic Innovation & Regulatory Science. 2021 Nov;55:1139-44.
  7. Moss B, Goodall EA, Maravic Z, et al. Real-world evidence research in metastatic colorectal cancer: raising awareness of the need for patient contributions. Future Oncology. 2023 Aug 1;19(26):1811-23.
  8. Sievers CK, Kratz JD, Zurbriggen LD, et al. The multidisciplinary management of colorectal cancer: present and future paradigms. Clinics in colon and rectal surgery. 2016 Sep;29(03):232-8.

Are randomized clinical trials enough: Why regulatory bodies are demanding more real-world evidence?

Medical Devices, Medical Publishing, Medical Writing,

Real-world evidence (RWE) has emerged as a critical complement to randomized clinical trials (RCTs) in healthcare regulatory decision-making. While RCTs remain the gold standard to assess an intervention and the efficacy of an intervention and are irreplaceable when testing the effect of new treatments, they often face limitations in terms of generalizability, cost, and timeliness. Derived from real-world data (RWD), RWE offers valuable insights into the effectiveness, safety, and economic impact of healthcare interventions in everyday clinical settings. It has become an essential part of integrated evidence generation, creating a continuous flow of information from the premarket to post-market approval decisions. By providing a meaningful clinical context, RWE bridges the gap between evidence of efficacy and effectiveness, enriching the decision-making process.

Although RWE has been used for years to support post-marketing approval and drug safety, the 21st Century Cures Act, enacted in December 2016, accelerated the use of RWE for regulatory submission.1 The act, designed to speed up medical product development and deliver innovations to patients more efficiently, has led to an increase in the use of RWE.2 For example, between 2017 and 2019, only 13% of evaluated oncology submissions to the FDA included RWE to support efficacy, compared to 70% from 2019 to 2021 using RWE to support efficacy and/or safety.1

The Role of Real-World Evidence in Regulatory Decision-Making

  1. Complementing RCTs

RCTs are highly controlled studies that provide robust evidence of efficacy and safety but are often limited by their strict inclusion and exclusion criteria, which may not reflect real-world patient populations. On the other hand, RWE captures data from diverse real-world settings, including patients with comorbidities, rare diseases, and those taking multiple medications, thereby enhancing the generalizability of the findings. Additionally, the RWE allows for the assessment of intervention values, considering both clinical and economic implications. Understanding real-world costs and outcomes is essential for optimizing resource allocation and ensuring the greatest value to patients and society.3,4

  1. Addressing Evidence Gaps

RWE is particularly valuable in addressing questions that RCTs cannot answer or do not answer. For example, RWE can provide long-term safety and effectiveness data, information on drug interactions, assess treatment outcomes in rare diseases, and evaluate the impact of medications in paediatric or geriatric populations.5,6 Additionally, RWE can inform decisions on drug labelling, post-marketing surveillance, and reimbursement.7

  1. Regulatory Applications

Regulatory bodies such as the U.S. Food and Drug Administration (USFDA), European Medicines Agency (EMA), and Health Canada have increasingly recognized the value of RWE in regulatory decision-making. In North America, both the FDA and Health Canada have created frameworks to integrate RWE into the regulatory process for premarket and post-market activities. The FDA’s 2018 framework emphasizes using RWE to modify drug labels and evaluate effectiveness, whereas Health Canada encourages its use for special populations and rare diseases. In Europe, the EMA has set out strategies, including the “Regulatory Science to 2025” document and Adaptive Pathways, to incorporate RWE throughout the drug lifecycle, with a focus on harmonizing data access and analysis within the EU. In Asia, countries such as China, Japan, and Taiwan, have developed specific guidelines for the use of RWE in drug development. China’s National Medical Products Administration (NMPA) emphasizes its use for rare diseases and label expansions, while Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) is working to refine methods for ensuring the reliability of registry data.8

Examples of RWE Improving Decision-Making

  1. COVID-19 Vaccine Deployment

During the COVID-19 pandemic, RWE was crucial in speeding up vaccine deployment by assessing vaccine effectiveness (VE) in real-world settings and complementing clinical trial data. Studies conducted in Denmark and Israel have provided valuable insights into VE against emerging variants and the effectiveness of booster doses. RWE also helped refine vaccination strategies and dosing regimens, offering evidence that RCTs couldn’t deliver on time. It supported safety monitoring and vaccine adaptation to new variants, enabling regulatory bodies to adjust dosing, guide on target populations, and optimize vaccine strategies for rapid decision-making.9

  1. Rare Disease Medicine Approvals

In the context of rare diseases, the RWE has been instrumental in broadening the indicated population for orphan drugs. A study analysing engagements with the EMA found that submissions, including RWE, resulted in a broader indicated population than those relying solely on RCT evidence. This highlights the potential of RWE to expand treatment access for rare diseases.10

  1. Medical Cannabis

RWE has also been used to support the approval of medical cannabis, where RCT evidence is often limited due to the challenges of studying whole-plant medicines. RWE studies, incorporating patient-reported outcomes, have demonstrated the positive impact of medical cannabis on patients’ lives, providing a broader evidence base for regulatory decisions.11

Challenges and Limitations of RWE

While RWE offers significant advantages, it also has limitations. Key challenges include concerns about data quality, potential biases, and lack of standardization in data collection and analysis. Additionally, RWE studies may lack the rigor of RCTs, and their findings may be influenced by confounding factors.4,6 To address these challenges, regulatory bodies stress the need for fit-for-purpose data, ensuring transparent study designs, and applying robust analytical methods.12

The Future of RWE in Regulatory Decision-Making

The integration of RWE into regulatory decision-making is expected to grow as methodologies improve and data quality is enhanced. Emerging trends, such as the use of artificial intelligence in healthcare and patient-generated data, offer new opportunities for leveraging RWE.4,13 Additionally, hybrid trial designs that combine elements of RCTs and RWE are being explored to generate evidence that is both robust and generalizable.14

Conclusion

Real-world evidence has become an indispensable tool for healthcare regulatory bodies, complementing the strengths of RCTs and addressing their limitations. By providing insights into real-world effectiveness, safety, and health economics impact, RWE has improved decision-making in areas where RCT data is insufficient. As methodologies evolve and data quality improves, the role of RWE in regulatory decision-making is expected to expand, offering new opportunities for advancing public health.

Turacoz specializes in leveraging RWE to support regulatory submissions, market access strategies, and healthcare decision-making. With expertise in data analytics, evidence synthesis, and regulatory compliance, we help pharmaceutical, and healthcare organizations integrate RWE into their product development and approval processes. From designing fit-for-purpose RWE studies to ensuring alignment with global regulatory frameworks, our tailored solutions empower clients to generate high-quality, actionable insights. By partnering with us, companies can enhance their evidence-generation strategies, optimize resource allocation, and accelerate patient access to innovative treatments.

References:

  1. Wilson BE, Booth CM. Real-world data: bridging the gap between clinical trials and practice. EClinicalMedicine. 2024;78:102915.
  2. Real-World Evidence. Available at: https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence#:~:text=The%2021st%20Century%20Cures%20Act,drug%20post%2Dapproval%20study%20requirements. Last accessed: March 2025.
  3. Hernandez RK, Critchlow CW, Dreyer N, et al. Advancing Principled Pharmacoepidemiologic Research to Support Regulatory and Healthcare Decision Making: The Era of Real-World Evidence. Clin Pharmacol Ther. Published online January 14, 2025.
  4. Bhatia N. Harnessing real-world evidence in pharmacoeconomics: A comprehensive review. Open Health. 2024:5(1).
  5. Prilla S, Groeneveld S, Pacurariu A, et al. Real-World Evidence to Support EU Regulatory Decision Making-Results From a Pilot of Regulatory Use Cases. Clin Pharmacol Ther. 2024;116(5):1188-1197.
  6. Bakker E, Plueschke K, Jonker CJ, et al. Contribution of Real-World Evidence in European Medicines Agency’s Regulatory Decision Making. Clin Pharmacol Ther. 2023;113(1):135-151.
  7. Pulini AA, Caetano GM, Clautiaux H, et al. Impact of Real-World Data on Market Authorization, Reimbursement Decision & Price Negotiation. Ther Innov Regul Sci. 2021;55(1):228-238.
  8. Burns L, Roux NL, Kalesnik-Orszulak R, et al. Real-World Evidence for Regulatory Decision-Making: Guidance From Around the World. Clin Ther. 2022;44(3):420-437.
  9. Bollaerts K, Wyndham-Thomas C, Miller E, et al. The role of real-world evidence for regulatory and public health decision-making for Accelerated Vaccine Deployment- a meeting report. Biologicals. 2024;85:101750.
  10. Jandhyala R. The effect of adding real-world evidence to regulatory submissions on the breadth of population indicated for rare disease medicine treatment by the European Medicines Agency. Pharm. Policy Pract. 2022:15.
  11. Schlag AK, Zafar RR, Lynskey MT, et al. The value of real world evidence: The case of medical cannabis. Front Psychiatry. 2022;13:1027159.
  12. Dreyer NA, Hall M, Christian JB. Modernizing Regulatory Evidence with Trials and Real-World Studies. Ther Innov Regul Sci. 2020;54(5):1112-1115.
  13. Dagenais S, Russo L, Madsen A, et al. Use of Real-World Evidence to Drive Drug Development Strategy and Inform Clinical Trial Design. Clin Pharmacol Ther. 2022;111(1):77-89.
  14. Andre EB, Reynolds R, Caubel P, et al. Trial designs using real-world data: The changing landscape of the regulatory approval process. Pharmacoepidemiol Drug Saf. 2020;29(10):1201-1212.

 

Why Ongoing Education for Healthcare Professionals is Crucial

Medical Devices, Medical Publishing, Medical Writing,

Healthcare is a constantly evolving field, where innovation, research, and technology shape patient care and outcomes. Ongoing education isn’t just a professional requirement – it’s a commitment to delivering the highest standard of care. Continuing Medical Education (CME) plays a vital role in ensuring that healthcare professionals (HCPs) remain informed, adaptable, and prepared to meet the dynamic needs of their patients and communities. Additionally, AI in medical education is transforming how HCPs learn and apply knowledge in real-time clinical settings.

When HCPs engage in continuous learning, they stay informed, adaptable, and prepared to meet the dynamic needs of their patients and communities.

KEY REASONS ONGOING EDUCATION BENEFITS HEALTHCARE

Enhanced patient outcomes
The updated knowledge and skills help to provide better diagnoses, treatments, and patient care strategies.

Studies show that HCPs who engage with the continuous education

  • Reduce medical errors by 30%1
  • Improve patient recovery rates by 20%2

Updated with medical advancements
New drug therapies, innovative treatment protocols, and emerging medical technologies help to shape modern healthcare. Ongoing education ensures

  • Adoption of the latest clinical guidelines3
  • Prescription of evidence-based treatments4
  • Enhanced patient safety through updated protocols1

Compliance with evolving regulations and guidelines
Healthcare policies and best practices change frequently. Staying informed ensures compliance, reduces liability and improves the quality of care. For example, updated infection control guidelines have been crucial in managing global health crises like COVID-19.5

Professional growth and career advancement
Continuous education opens doors to career progression, specialization opportunities, and leadership roles. HCPs who pursue further training are 25% more likely to attain senior positions.² With advancements in technology-driven medical education, professionals can access flexible training that enhances their qualifications and career prospects.

Adapting to technological innovations
From AI-powered diagnostics to robotic-assisted surgeries, technology is revolutionizing healthcare. HCPs who receive ongoing education in digital health can

  • Increase diagnostic accuracy
  • Optimize workflow efficiency

Enhance patient engagement through telemedicine

REAL-WORLD IMPACT OF ONGOING EDUCATION IN HEALTHCARE

  • Reducing hospital readmissions – HCPs trained in post-discharge care strategies lower readmission rates by 15%.5
  • Improving emergency response – Advanced training in emergency care boosts survival rates for critical cases by 40%.5
  • Strengthening public health initiatives – Continuous education enables HCPs to drive better vaccination campaigns, disease prevention, and health promotion efforts.
  • Better interdisciplinary collaboration – Education fosters stronger teamwork among doctors, nurses, and specialists, improving overall healthcare efficiency.

CHALLENGES TO CONTINUOUS EDUCATION & SOLUTIONS

THE PATH FORWARD: A CALL TO ACTION

Investing in ongoing education for healthcare professionals is an investment in better healthcare for all. Supporting continuous learning opportunities ensures that providers

  • Deliver the highest quality care
  • Stay ahead of medical advancements
  • Contribute to improved patient outcomes worldwide

Healthcare never stands still—neither should learning. What step will you take today to stay ahead?

Turacoz is committed to empowering healthcare professionals (HCPs) by providing specialized training on the integration of Artificial Intelligence (AI) in medical education. Our programs are designed to help HCPs leverage AI-driven tools for enhanced learning, clinical decision-making, and patient management. Through interactive workshops, case-based discussions, and hands-on training, we equip professionals with the knowledge to utilize AI-powered diagnostics, predictive analytics, and personalized learning platforms effectively. By bridging the gap between technology and healthcare education, Turacoz ensures that HCPs stay ahead in the evolving medical landscape, improving both educational outcomes and patient care.

References:

  1. World Health Organization. Global patient safety action plan 2021–2030. Available from: https://www.who.int/publications/i/item/9789240032705
  2. National Institutes of Health. The impact of continuing education on professional growth. Available from: https://www.nih.gov/research-training/training-opportunities
  3. World Health Organization. Global guidelines and implementation strategies for clinical practice. Available from: https://www.who.int/publications/guidelines
  4. Agency for Healthcare Research and Quality (AHRQ). Evidence-based practice centers (EPCs) [Internet]. Rockville (MD): AHRQ. Available from: https://www.ahrq.gov/research/findings/evidence-based-reports/index.html

Centers for Disease Control and Prevention. Strategies to reduce hospital readmissions. Available from: https://www.cdc.gov/healthcare/quality/reduction-of-hospital-readmissions.html

Breaking the Silence: Why Chronic Kidney Disease Awareness Needs Better Communication

Medical Publishing, Medical Writing,

Chronic kidney disease (CKD) is often called ‘silent killer’ as most people live with it for years without symptoms. In resource-limited settings, up to 9 out of 10 individuals with CKD are unaware of their condition, delaying crucial interventions.1 Despite being a growing global health crisis, kidney disease remains widely misunderstood and under-communicated, leading to severe health and economic consequences. Kidney Awareness Month serves as a critical opportunity to amplify education and encourage early detection.

A Growing Global Crisis

CKD affects approximately 850 million people worldwide and is the third fastest-growing cause of death. By 2040, it is projected to become the fifth leading cause of premature mortality.1 Modern lifestyle diseases—such as diabetes and hypertension significantly contribute to this burden, with 1 in 3 adults and 1 in 5 adults at risk of developing this disease, respectively.2

Additionally, prolonged use of nonsteroidal anti-inflammatory drugs (NSAIDs) poses a growing threat. Around 30 million people globally consume NSAIDs daily,3 and unmonitored long-term use can worsen kidney function, further increasing CKD prevalence.

The Economic Toll of CKD

Beyond health risks, CKD imposes a profound economic burden. By 2027, the direct annual costs of diagnosed CKD and kidney replacement therapy (KRT) are expected to reach $406.7 billion.4

The challenge is particularly severe in low- and middle-income countries, where about 78% of patients with CKD reside, and health systems struggle with limited resources and systemic inequalities.5 The financial burden frequently falls on families, leading to catastrophic health expenditures. Patients often lose their ability to work, further impacting household income and national productivity.

Unawareness and the Problem of Late Diagnosis

More than 90% of people with early-stage CKD are unaware of their condition.1 The disease progresses silently, often overlooked until symptoms appear increasing risk for serious health complications such as heart attack, stroke, and kidney failure. Understanding the stages of kidney disease is crucial in recognizing progression and taking necessary preventive measures. Early detection through screening and risk stratification could significantly reduce morbidity and mortality. However, at present, there is no accepted systematic strategy for CKD screening and treatment.

For example, in the United States, over 20% of individuals with hypertension have increased albuminuria, yet only 7% have tested for it.6 Delayed diagnoses also raises treatment cost by 19% compared to early detection.7 Additionally, Late-stage CKD often requires dialysis or transplants, both costly and with limited accessibility.

In contrast, early-stage CKD can often be managed effectively through medication, lifestyle changes, and controlling underlying conditions like diabetes and hypertension. But this is only possible when the disease is identified in time.

Treatment Affordability and Accessibility

Kidney disease is not just a health issue—it’s a socioeconomic challenge. In many countries, dialysis centres are concentrated in urban areas, leaving rural populations underserved. Even when available, treatment is expensive, with annual costs reaching $19,380 for dialysis and up to $26,903 for the first year of a kidney transplant.8 Many patients delay or forgo treatment due to financial constraints, worsening outcomes.

Strengthening Awareness, Early detection, and Communication

Kidney Awareness Month is a key initiative that seeks to promote education, encourage early screening, and advocate for health policies that support kidney patients. World Kidney Day, led by the International Society of Nephrology (ISN) and the International Federation of Kidney Foundations (IFKF), also aims to enhance kidney health education and drive policy changes.

Incorporating CKD screening into public health initiatives enhances cost efficiency and resource utilization. Successful examples include Thailand’s Screening and Early Evaluation of Kidney Disease program and South Africa’s HIV Treatment Program, which has integrated serum creatinine testing to monitor kidney function.5

Digital and mobile platforms offer scalable CKD screening solutions. In rural India, telehealth programs and point-of-care (POC) testing for creatinine and urine albumin have improved risk assessment and diagnostic accuracy at the primary care level.5

Public health messaging should emphasize kidney health through lifestyle choices—nutrition, hydration, exercise, and routine screening. Stronger communication strategies, including public education campaigns, HCP engagement, social media outreach, and community initiatives, are crucial, especially for underserved groups. Addressing the emotional and social aspects of CKD can empower patients, reduce stigma, and encourage timely care-seeking.

Conclusion: Early Action Saves Lives

Kidney disease is a growing global health threat, but it is also one that can be detected early, managed effectively, and even prevented—provided the right information reaches the right people at the right time.

Enhancing communication about kidney disease is not just a public health priority but a moral responsibility. With better education, awareness, and timely intervention, we can help millions avoid the severe consequences of this silent epidemic.

References:

  1. Francis A, Harhay MN, Ong ACM, et al. Chronic kidney disease and the global public health agenda: an international consensus. Nat Rev Nephrol. 2024;20(7):473-485.
  2. Preventing Chronic Kidney Disease. Available at: https://www.cdc.gov/kidney-disease/prevention/index.html#:~:text=Manage%20CKD%20risk%20factors,Family%20history%20of%20CKD. Last accessed: March 2025.
  3. Montuori P, Shojaeian SZ, Pennino F, et al. Consumer awareness and knowledge regarding use of non-steroidal anti-inflammatory drugs (NSAIDs) in a metropolitan area. Front Pharmacol. 2024;15:1362632.
  4. Chadban S, Arıcı M, Power A, et al. Projecting the economic burden of chronic kidney disease at the patient level (Inside CKD): a microsimulation modelling study. EClinicalMedicine. 2024;72:102615.
  5. Wijewickrama E and Kalyesubula R. World Kidney Day: Detecting Kidney Disease in Low- and Middle-Income Countries. Kidney Int Rep. 2025;10:637–640.
  6. Shlipak MG, Tummalapalli SL, Boulware LE, et al. The case for early identification and intervention of chronic kidney disease: conclusions from a Kidney Disease: Improving Global Outcomes (KDIGO) Controversies Conference. Kidney Int. 2021;99(1):34-47.
  7. Spencer D, Dunning S, McPheeters J, St Clair Russell J, Hane C. Health care costs associated with unrecognized progression to late-stage kidney disease. Am J Manag Care. 2023;29(2):e64-e68.

Bello AK, Okpechi IG, Levin A, et al. An update on the global disparities in kidney disease burden and care across world countries and regions. Lancet Glob Health. 2024;1

Bridging the Gap: How Women’s Empowerment Drives Global Health Improvements

Medical Publishing, Medical Writing,

Imagine a world where every woman has the power to make decisions about her health, future, and family’s well-being. A world where women are not just patients but policymakers, not just caregivers but change-makers. This isn’t just an ideal—it’s a necessity. Women’s empowerment is not only about fairness; it is a fundamental driver of global health and economic progress. When women have access to education, financial resources, and quality healthcare, they uplift entire communities. Yet, despite undeniable progress, many women still face barriers that prevent them from achieving optimal health and well-being. Addressing these challenges through policy, advocacy, and leadership opportunities is essential for fostering a healthier, more equitable world.

Women as pillars of global health

Women play a fundamental role in health systems—not only as caregivers in their families but also as healthcare professionals, policymakers, and advocates. Studies have shown that societies with stronger female leadership representation experience improved health outcomes. For instance, Rwanda, where women hold over 60% of parliamentary seats, has seen notable progress in reducing maternal and child mortality rates.1,2

Moreover, female-led health initiatives tend to prioritize community well-being, increasing access to essential services such as vaccinations, maternal healthcare, and family planning. Women leaders are more likely to invest in equitable healthcare solutions that address the unique needs of women and children.3

Bridging the gap: Gender disparities in health

Despite their critical role, women often face disproportionate barriers to healthcare access. Gender inequalities manifest in various ways, including restricted access to reproductive health services, economic dependency that limits medical decision-making, and cultural norms that discourage seeking care. The World Health Organization (WHO) has identified gender-based violence and inadequate access to sexual and reproductive health services as key issues affecting women’s overall health.4

Furthermore, the intersection of gender and economic status exacerbates health disparities. Women in low-income settings are less likely to receive preventive care, leading to higher incidences of maternal mortality and untreated chronic illnesses.

Empowering women through healthcare access

Ensuring universal health coverage for women requires a multifaceted approach that includes:

  • Expanding access to reproductive health services: Family planning, maternal health programs, and reproductive rights are crucial for reducing unintended pregnancies and maternal mortality.
  • Addressing gender-based violence: Implementing survivor-centered healthcare responses and prevention strategies in high-prevalence regions is necessary to mitigate health consequences of violence against women.
  • Investing in women’s health leadership: Increasing female representation in health policymaking ensures that gender-specific health concerns are adequately addressed.
  • Economic empowerment programs: Cash transfer programs directed at women have shown positive impacts on family health outcomes, reinforcing the connection between financial independence and improved well-being.

Women as agents of change

Numerous examples highlight the transformative power of women’s leadership in health.

Dr. Soumya Swaminathan, former Chief Scientist at WHO, has been instrumental in global health policy, particularly in tackling tuberculosis, infectious diseases, and pandemic preparedness.

Dr. Kiran Mazumdar-Shaw, founder of Biocon, has revolutionized India’s biotechnology sector by pioneering affordable insulin and cancer treatments. Through her innovations, she has ensured greater access to life-saving medicines, particularly for low-income communities, and has championed women’s leadership in STEM and healthcare innovation.

Furthermore, grassroots movements led by women in developing nations have been instrumental in tackling health crises. Community-driven initiatives focusing on malaria prevention, maternal health, and child nutrition have significantly reduced disease burdens in low-resource settings. For example, the Self-Employed Women’s Association (SEWA) in India has improved access to healthcare for informal workers, helping women take charge of their own health.

A call to action

Empowering women in health is not just about fairness—it is about effectiveness. The evidence is clear: when women have control over their health and economic resources, societies thrive.

  • Support female-led health initiatives by advocating for policies that increase women’s leadership in healthcare and research.
  • Encourage education and training for women in medicine, public health, and policymaking.
  • Challenge harmful gender norms that limit women’s access to healthcare and economic independence.

By prioritizing gender-inclusive health policies and investing in women as decision-makers, we can move closer to a world where health equity is a reality for all.

What role will you play in empowering women for better global health?

References

  1. UN Women. Rwanda – Women, peace and security [Internet]. 2024 [cited 2025 Mar 3]. Available from: https://data.unwomen.org/country/rwanda
  2. UN Women. Beijing +30 Report: Rwanda – Advancing gender equality and women’s empowerment [Internet]. 2024 [cited 2025 Mar 3]. Available from: https://www.unwomen.org/sites/default/files/2024-09/b30_report_rwanda_en.pdf
  3. Gender-equitable families and health systems are better for children [Internet]. 2024 [cited 2025 Mar 3]. Available from: https://www.defeatdd.org/campaign/gender-equitable-families-and-health-systems-are-better-children/
  4. World Health Organization. Violence against women and girls [Internet]. 2024 [cited 2025 Mar 3]. Available from: https://www.who.int/teams/sexual-and-reproductive-health-and-research-%28srh%29/areas-of-work/violence-against-women-and-girls

Empowering Women Through Health: The Importance of Preventive Care at Every Stage of Life

Medical Publishing, Medical Writing,

Recently, while working on a project about preeclampsia during pregnancy, our team was startled to learn that preeclampsia is one of the most common hypertensive disorders of pregnancy, accounting for 2%–8% of pregnancy-related complications, more than 50,000 maternal deaths, and over 500,000 fetal deaths worldwide.1 Yet, many women are unaware that early diagnosis and prompt symptomatic management can help prevent such maternal and neonatal complications. The need of the hour is to empower women with knowledge and awareness about their health so that they can proactively prioritize their well-being while juggling multiple responsibilities.
Below are ten essential steps all women should undertake to keep all diseases at bay for themselves and their families.

Understand the food labels before buying food items

According to the World Health Organization (WHO), the increased consumption of processed foods high in salt, sugar, and fat is a key driver of a global obesity crisis. Currently, more than a billion people live with obesity,2 and an estimated 17 million early deaths occur every year due to noncommunicable diseases such as diabetes and heart disease.3 Studies have shown that some of the most frequently present additives in children’s food include bisphenols, phthalates, perfluoroalkyl chemicals, perchlorates, pesticides, nitrates and nitrites, artificial food colors, monosodium glutamate, and aspartame—all of which can be harmful to a child’s growth and development. As women are more involved in feeding their families, they must understand the nutritional labels and their implications. The next time you pick up a packet of your favorite snack, do not blindly trust the brand—read the fine print carefully.

Stay physically active

A recent study involving 5000 postmenopausal women in California supports the importance of regular physical activity and reduced sedentary time in lowering mortality risk, regardless of their genetic predisposition for longevity. Women who do strength training exercises 2–3 times a week are more likely to live longer and have a 30% lower risk of death from heart disease compared to those who do not exercise.4

Get screened for common cancers

According to the American Cancer Society, breast cancer is the second leading cause of cancer-related deaths in women, with the lifetime risk of 1 in 43.5 Young women are more likely to develop aggressive forms of breast cancer, often linked to genetic factors such as inherited mutations in the BRCA genes, highlighting the importance of undergoing BRCA testing. Studies have demonstrated that early detection of breast cancer can lead to a 100% survival rate, especially when the cancer is localized.6 Another major cancer affecting women is cervical cancer, which the WHO ranks as the fourth leading cause of cancer-related deaths among women, causing 350,000 deaths in 2022.7 Persistent HPV infections are the primary cause of cervical cancer, and vaccination between the ages of 9 and 14 is an effective preventive measure. Studies indicate that unvaccinated women are ten times more likely to develop cervical cancer than those who are vaccinated.8 Therefore, to maintain good health and a high quality of life, women should prioritize regular checkups, early detection screenings, and staying up to date with vaccinations.

Test your blood sugar regularly

Recent studies have demonstrated that 10.5% of the adult population has diabetes,9 with nearly half unaware of their condition, leading to untreated diabetes and increasing the risk of cardiovascular (CV), renal, and neurological complications.10 Research has shown that early detection and treatment of type 2 diabetes can reduce the risk of CV complications by 29%–38%, emphasizing the importance of early detection. Regular blood sugar testing plays a vital role in this process.11 With glucometers now widely available, women can easily monitor their own and their family’s blood sugar levels, even with their busy schedules, and promptly seek medical attention if any irregularities are detected.

Mental health matters

Women are three times more likely to experience mental health issues than men.12 Poor mental health not only impacts physical well-being but also decreases workplace productivity by nearly 13%,13 with twelve billion working days lost annually due to depression and anxiety.14 Furthermore, about 10% of pregnant women and 13% of postpartum women experience mental health disorders, primarily depression, which can negatively affect both the mother’s well-being and the child’s growth and development.15 These statistics are concerning and highlight the importance of prioritizing mental health. Women can support their well-being by adopting healthy habits such as regular exercise, balanced diet, self-care, and maintaining social connections.

Understand the needs of your changing body

Menopause, marking the end of reproductive years, often lacks the attention it deserves despite its significant impact. It leads to a decline in estrogen, causing symptoms like irregular periods, hot flashes, night sweats, insomnia, vaginal dryness, and mental health challenges like mood swings, anxiety, and depression. Menopause is also a major risk factor for osteoporosis, affecting 1 in 3 women.16 Hormone replacement therapy (HRT) is most effective when started within 10 years of menopause or before age 60. HRT helps relieve menopausal symptoms, prevents bone loss, and reduces the risk of fractures by 20%–40%.17 Hence, women should consult their doctor early for best results. Additionally, calcium and vitamin D supplements, a healthy diet, an active lifestyle, and cognitive behavioral therapy can help manage symptoms further.

Keep your weight under control

PCOS, hypothyroidism, Cushing’s syndrome, insulin resistance, stress, and emotional eating are the common health issues that can lead to weight gain in women. Studies show that 38%–88% of women with PCOS are either overweight or obese, which can negatively impact their menstrual and reproductive health.18 However, even a modest weight loss of 5% in obese women with PCOS can help alleviate symptoms.19 Regarding hypothyroidism, women are 8–9 times more likely to develop the condition, with the highest incidence between the ages of 30 and 50.20 Gaining a few pant sizes can be a key symptom of hypothyroidism. Women experiencing this should seek prompt medical advice and undergo appropriate treatment, as weight gain can lead to additional complications such as cardiovascular disease (CVD), joint issues, sleep apnea, and psychological distress.

Rely on nutrition for healthy skin and hair

The quest for healthy skin and hair often leads women to explore a wide range of cosmetic products. However, emerging research suggests that nutrition plays a far more significant role in maintaining and enhancing skin and hair health. Rather than relying on topical treatments, proper nutrition addresses the root causes of skin and hair concerns by supplying the body with essential nutrients. Many common chemicals found in skincare products, such as sodium lauryl sulfate, phthalates, fragrances, mineral oils, lead, and formaldehyde, can have harmful effects on the skin and other organs. In contrast, studies have shown that consuming antioxidant-rich foods can reduce photoaging by 10% over 15 years compared to diets low in antioxidants.21 Similarly, for hair health, research reveals that incorporating omega-3 fatty acids into the diet can improve scalp hydration and increase hair shine. These findings highlight how nutrition offers a safer and more effective approach to achieving and maintaining healthy skin and hair, as opposed to relying on potentially harmful cosmetics.

Relax and sleep well

Research shows that inadequate sleep negatively affects women’s mental, physical, and reproductive health, along with daily functioning. Studies reveal concerning patterns that underscore the importance of adequate sleep. Chronic sleep deprivation (less than 6 hours per night) is correlated with a higher body mass index, 22 15% increased risk of CVD, 23% higher risk of coronary heart disease,23 and increased likelihood of developing diabetes.24 .26 By adhering to a consistent good sleep routine, women may mitigate these health risks.

Avoid smoking and alcohol consumption

According to WHO data, tobacco use causes more than eight million deaths each year, whereas alcohol consumption is responsible for 2.6 million deaths.27,28 Research has shown that alcohol misuse and smoking are rising among women, posing serious health risks not only for them but also for their babies. Studies indicate that babies born to mothers who smoke are twice as likely to have a lower birth weight compared to those born to nonsmoking mothers.29 In fact, 14% of all deaths due to low birth weight are linked to tobacco use during pregnancy.29 Moreover, heavy alcohol consumption in women is associated with a more rapid onset of health conditions such as CVD, obesity, and various cancers. These findings highlight the importance of cutting back or abstaining from these habits. To stay on track, it is essential to recognize triggers, avoid situations that tempt you, find healthier coping mechanisms such as exercising or picking up new hobbies, and seek support from friends and family.

In conclusion, discipline is the key to a healthy life. By incorporating a few simple healthy habits into your daily routine, you set yourself up for a future filled with health and happiness. Take charge of your life—stay vigilant, act quickly when needed, do not hesitate to ask for help, and stay strong. Everything will fall into place. Remember, prioritizing your health and scheduling regular checkups is not just about taking care of your body, it is about empowering yourself. Staying up to date with the latest health information and educating yourself on wellness is just as important, as it helps you make informed choices and stay ahead. By prioritizing your well-being, you truly embody the strength of an empowered woman.

  1. Karrar SA, Martingano DJ, Hong PL. [Updated 2024 Feb 25]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available at: https://www.ncbi.nlm.nih.gov/books/NBK570611/.
  2. One in eight people are now living with obesity. Available at: https://www.who.int/news/item/01-03-2024-one-in-eight-people-are-now-living-with-obesity. Last accessed: March 2025.
  3. Cardiovascular disease. Available at: https://www.who.int/news-room/fact-sheets/detail/cardiovascular-diseases-(cvds)#:~:text=In%202013%2C%20WHO%20Member%20States,on%20preventing%20and%20controlling%20CVDs . Last accessed: March 2025.
  4. Study: Women who do strength training live significantly longer. Available at: https://globalwellnessinstitute.org/global-wellness-institute-blog/2024/05/28/study-women-who-do-strength-training-live-significantly-longer/#:~:text=Study:%20Women%20Who%20D,Access%20this%20study%20on%20exercise. Last accessed: March 2025.
  5. Key statistics for breast cancer. Available at: https://www.cancer.org/cancer/types/breast-cancer/about/how-common-is-breast-cancer.html#:~:text=Breast%20cancer%20is%20the%20second,decline%20of%2044%25%20through%202022. Last accessed: March 2025.
  6. Li J, Guan X, Fan Z, et al. Non-Invasive Biomarkers for Early Detection of Breast Cancer. Cancers (Basel). 2020;12(10):2767.
  7. Cervical cancer. Available at: https://www.who.int/news-room/fact-sheets/detail/cervical-cancer#:~:text=Cervical%20cancer%20is%20the%20fourth,compared%20to%20women%20without%20HIV. Last accessed: March 2025.
  8. Naslazi E, Hontelez JAC, Naber SK, et al. The Differential Risk of Cervical Cancer in HPV-Vaccinated and -Unvaccinated Women: A Mathematical Modeling Study. Cancer Epidemiol Biomarkers Prev. 2021;30(5):912-919.
  9. Sun H, Saeedi P, Karuranga S, et al. IDF Diabetes Atlas: Global, regional and country-level diabetes prevalence estimates for 2021 and projections for 2045 [published correction appears in Diabetes Res Clin Pract. 2023;204:110945.
  10. Hossain MJ, Al-Mamun M, Islam MR. Diabetes mellitus, the fastest growing global public health concern: Early detection should be focused. Health Sci Rep. 2024;7(3):e2004.
  11. Herman WH, Ye W, Griffin SJ, et al. Early Detection and Treatment of Type 2 Diabetes Reduce Cardiovascular Morbidity and Mortality: A Simulation of the Results of the Anglo-Danish-Dutch Study of Intensive Treatment in People With Screen-Detected Diabetes in Primary Care (ADDITION-Europe). Diabetes Care. 2015;38(8):1449-1455.
  12. Men and women: Statistics. Available at: https://www.mentalhealth.org.uk/explore-mental-health/statistics/men-women-statistics#:~:text=Women%20between%20the%20ages%20of,the%20same%20age%20(9%25).&text=Women%20are%20twice%20as%20likely%20to%20be%20diagnosed%20with%20anxiety%20as%20men. Last accessed: March 2025.
  13. Happy workers are 13% more productive. Available at: https://www.ox.ac.uk/news/2019-10-24-happy-workers-are-13-more-productive. Last accessed: March 2025.
  14. Mental health at work. Available at: https://www.who.int/news-room/fact-sheets/detail/mental-health-at-work. Last accessed: March 2025.
  15. Perinatal mental health. Available at: https://www.who.int/teams/mental-health-and-substance-use/promotion-prevention/maternal-mental-health. Last accessed: March 2025.
  16. Prevention and treatment of osteoporosis in postmenopausal women. Available at: https://thebms.org.uk/wp-content/uploads/2023/10/06-BMS-ConsensusStatement-Prevention-and-treatment-of-osteoporosis-in-women-SEPT2023-A.pdf. Last accessed: March 2025.
  17. Gosset A, Pouillès JM, Trémollieres F. Menopausal hormone therapy for the management of osteoporosis. Best Pract Res Clin Endocrinol Metab. 2021;35(6):101551.
  18. Barber TM. Why are women with polycystic ovary syndrome obese? Br Med Bull. 2022;143(1):4-15.
  19. Treatment, polycystic ovary syndrome. Available at: https://www.nhs.uk/conditions/polycystic-ovary-syndrome-pcos/treatment/#:~:text=In%20overweight%20women%2C%20the%20symptoms,a%20significant%20improvement%20in%20PCOS. Last accessed: March 2025.
  20. Chiovato L, Magri F, Carlé A. Hypothyroidism in Context: Where We’ve Been and Where We’re Going. Adv Ther. 2019;36(2):47-58.
  21. Hughes MCB, Williams GM, Pageon H, et al. Dietary Antioxidant Capacity and Skin Photoaging: A 15-Year Longitudinal Study. J Invest Dermatol. 2021;141(4S):1111-1118.e2.
  22. Papatriantafyllou E, Efthymiou D, Zoumbaneas E, et al. Sleep Deprivation: Effects on Weight Loss and Weight Loss Maintenance. Nutrients. 2022;14(8):1549.
  23. Hoevenaar-Blom MP, Spijkerman AM, Kromhout D, et al. Sleep duration and sleep quality in relation to 12-year cardiovascular disease incidence: The MORGEN study. Sleep. 2011;34(11):1487-1492.
  24. Darraj A. The Link Between Sleeping and Type 2 Diabetes: A Systematic Review. Cureus. 2023;15(11):e48228.
  25. The close relationship between sleep and mental health. Available at: https://www.medicalnewstoday.com/articles/sleep-and-mental-health. Last accessed: March 2025.
  26. Beroukhim G, Esencan E, Seifer DB. Impact of sleep patterns upon female neuroendocrinology and reproductive outcomes: A comprehensive review. Reprod Biol Endocrinol. 2022;20(1):16.
  27. Available at: https://www.who.int/news-room/fact-sheets/detail/alcohol#:~:text=Worldwide%2C%202.6%20million%20deaths%20were,per%20100%20000%20people%2C%20respectively. Last accessed: March 2025.
  28. Available at: https://www.who.int/news-room/fact-sheets/detail/tobacco#:~:text=Tobacco%20kills%20up%20to%20half,are%20Parties%20to%20this%20treaty. Last accessed: March 2025.
  29. Tobacco in Australia, facts and issues. Available at: https://www.tobaccoinaustralia.org.au/chapter-3-health-effects/3-8-child-health-and-maternal-smoking. Last accessed: March 2025.

Pharma’s Shift to Patient-Centric Models: How Listening to Patients Drives Better Health Outcomes

Medical Devices, Medical Publishing, Medical Writing,

The pharmaceutical industry is undergoing a significant transformation. In the past, the focus was primarily on research, development, and approval processes driven by science and regulations. However, today’s landscape is evolving to prioritize what truly matters — delivering effective, affordable treatments to patients faster. For instance, in 2020, the rapid development and approval of COVID-19 vaccines in less than a year showed the power of collaboration, new technologies, and streamlined processes, setting a new precedent for how the industry can respond to urgent health crises.

The shift to patient-centricity is one of the most profound changes to impact the industry in recent years. As patients take on more responsibility for their own healthcare, their voices are becoming more influential in shaping the direction of pharmaceutical development and treatment options.

Why is Patient-Centric approach is so Important?

Patients are no longer passive recipients of care. Patients today are well-informed, actively involved in their healthcare decisions, and expect both healthcare providers and pharmaceutical companies to listen to their needs. This shift is not only about improving the patient’s experience but also about ensuring better outcomes in drug development, clinical trials, and treatment efficacy.

As we look ahead, here are a few key reasons why patient-centric models are crucial for the future of pharma:

  1. Improved Patient Health Outcomes
    Evidence shows that patient-centered care significantly improves clinical outcomes. A study on adolescents with diabetes highlights that key element—improved patient-provider communication, providing symptom information, and addressing concerns—are linked to better psychosocial health outcomes. The findings reveal a strong correlation (r ≥ 0.3) between these factors and improved patient-reported outcomes. This reinforces that prioritizing patients’ preferences and needs enhances treatment effectiveness and overall health results (Vasanwala et al 2022). By integrating patient feedback into the drug development process, pharmaceutical companies can design treatments that are more aligned with patients’ real-world needs. Whether it’s reducing side effects, improving drug delivery methods, or ensuring easier access to medications, listening to patients is key to developing effective therapies that work in practice — not just in theory.
  1. Enhanced Patient Engagement
    A recent study on patient’s beliefs about medicine and adherence shows that patients who perceive higher levels of people-centered care (PCC) are more likely to adhere to prescribed medications. Each point increase in PCC corresponds to a 7% higher chance of adherence, underscoring how active patient engagement and listening to their needs and beliefs about treatment can lead to better health outcomes. Patients who are actively engaged in their treatment are more likely to adhere to prescribed therapies, leading to better health outcomes. By involving patients in their care journey, pharmaceutical companies can enhance engagement, trust, and overall satisfaction. This shift is not just about providing a product but about offering a comprehensive healthcare solution that fits into a patient’s life (Dilles et al 2023).
  2. Bridging the Gap in Clinical Trials
    Historically, clinical trials have had limited diversity and were often not fully representative of the populations that would ultimately use the drugs. By adopting patient-centric approaches, companies can ensure that trials are more inclusive, ensuring a broader range of patient experiences, which leads to more relevant and effective treatments.
  3. Building Trust Through Transparency
    Recent advances in patient engagement show improved health outcomes across prevention and chronic disease management. Addressing health literacy and ensuring clear, actionable information is key. Gaps remain in effectively engaging patients, especially in decision-making and self-management. Future efforts should integrate patient feedback from wearables, improve information navigation, and involve patients in designing healthcare systems, policies, and research to make patient engagement a cultural norm for better health outcomes. Patients today want to know how treatments are being developed, the risks involved, and how their data is being used. Pharma companies that communicate openly with patients build trust, foster long-term relationships and ensure better patient cooperation and compliance.

How Medical Communications Agencies Support Patient-Centric Models

While the shift to patient-centricity is a broad industry-wide movement, medical communications agencies play a critical role in ensuring that pharma companies effectively implement these models. Here’s how they contribute to the patient-centric process:

  1. Bridging the Communication Gap
    Medical communications agencies can facilitate clear, effective communication between pharmaceutical companies and patients. Through the creation of educational materials, online platforms, and patient-facing content, agencies ensure that patients are fully informed about treatments, potential side effects, and clinical trial options. This transparency helps build trust and encourages patient engagement.
  2. Developing Patient-Centered Content
    Agencies specializing in medical communications create content that resonates with patients, ensuring that it’s not only scientifically accurate but also accessible and empathetic. Whether through print, digital channels, or social media, agencies ensure that the content speaks directly to patients’ concerns, empowering them with information that helps them make informed decisions about their treatment options.
  3. Facilitating Patient Advocacy Partnerships
    Medical communications agencies often collaborate with patient advocacy groups to ensure that patients’ voices are heard in the development process. Agencies help to amplify the concerns and needs of patient communities, ensuring that pharma companies are aware of the specific issues patients face. This collaboration leads to more inclusive and responsive drug development strategies.
  4. Enhancing Patient Engagement Strategies
    Agencies help design and execute strategies for sustained patient engagement, whether through digital tools, community forums, or targeted campaigns. By utilizing real-time patient feedback, agencies ensure that pharma companies are continually improving their patient-centric approaches and creating solutions that meet evolving patient needs.
  5. Optimizing Clinical Trial Recruitment
    Medical communications agencies can assist pharmaceutical companies in reaching out to a diverse patient population for clinical trials. They help design recruitment campaigns that are tailored to various patient groups, ensuring that trials reflect the diverse populations that will eventually benefit from the drugs. Moreover, agencies provide ongoing support to patients throughout the trial process, increasing retention and improving overall success rates.

The Road Ahead: A Patient-First Future

The transition to a patient-centric model in the pharmaceutical industry is not just a trend — it’s a necessity. As the demand for more personalized, effective, and accessible healthcare continues to grow, pharma companies must keep patients at the forefront of their strategies.

By truly listening to patients and involving them in every step of the journey, from drug discovery to post-market support, pharmaceutical companies can help create a future where treatments are not only more effective but also more aligned with the needs of the people they are designed to help.

Ultimately, a patient-first approach doesn’t just lead to better outcomes — it leads to a healthier, more informed world. As industry continues to evolve, embracing patient-centric models will be the key to transforming lives and advancing healthcare for generations to come.

References:

  1. Vasanwala, R., Lim, A., Soo Ting, L., Pei Kwee, L., Yuen Ching, H., & Xiang Feng, T. (2022). The impact of patient-centered care on health outcomes in adolescents living with diabetes. Patient Experience Journal, 9(1), 46–53. https://doi.org/10.35680/2372-0247.1619
  2. Dilles, T., Mortelmans, L., Loots, E., Sabbe, K., Feyen, H., Wauters, M., Haegdorens, F., & De Baetselier, E. (2023). People-centered care and patients’ beliefs about medicines and adherence: A cross-sectional study. Heliyon, 9(5), e15795. https://doi.org/10.1016/j.heliyon.2023.e15795

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Advancing Genitourinary Cancer Treatment: The Critical Role of Medical Communications Agencies in Clinical Trials and Data Dissemination

Medical Writing, Publication Writing, Scientific Writing

Introduction to Genitourinary Cancer Treatment

Genitourinary (GU) cancers—including prostate, bladder, kidney, and testicular cancers—represent a significant proportion of global cancer cases. In 2023, prostate cancer was the second most common cancer in men around the world. There were about 1.4 million new cases and around 375,000 deaths (Sung et al., 2021). Despite major advancements in oncology, effectively translating clinical research management findings into accessible and actionable knowledge remains a challenge for advancing Genitourinary Cancer Treatment in 2025.

Medical communications agencies, like Turacoz Group, are important for sharing complex clinical trial data by managing phases of clinical trials, conducting proper research management and journal publication submissions to help experts identify appropriate treatment for various types of Genitourinary cancers including prostate and bladder cancer treatment. The role of Medical Communication Agencies is to make sure this information reaches stakeholders, such as doctors, regulatory authorities, and patients. Their expertise in scientific writing, regulatory documentation, publication planning, and stakeholder engagement ensures that life-saving therapies and treatment reaches patients efficiently and ethically.

The Growing Burden of Genitourinary Cancers

The incidence of GU cancers continues to rise, necessitating innovative treatment approaches and effective management of clinical trial data:

  • Prostate Cancer is the most common genitourinary cancer. It has a 5-year survival rate of nearly 99% in localized cases treatment. However, this rate is much lower in metastatic disease treatment (Siegel et al., 2023).
  • Bladder Cancer: Characterized by high recurrence rates, requiring ongoing clinical trials to refine treatment strategies (Antoni et al., 2017). Bladder Cancer Tumour is curable if identified early with a cure rate of 95% of patients surviving 5 Years or more.
  • Renal Cell Carcinoma (RCC): Accounts for 85% of kidney cancers, often diagnosed incidentally at advanced stages (Capitanio & Montorsi, 2016).
  • Testicular cancer is a rare type of cancer. However, it has a high cure rate of over 95% when found early (Ghazarian et al., 2017).

With immune checkpoint inhibitors, targeted therapies, and next-generation hormonal agents reshaping the treatment landscape, the role of strategic medical communications in clinical trial success and regulatory approvals is more important than ever especially for prostate cancer immunotherapy clinical trials.

The Role of Medical Communications Agencies in Clinical Trials

Medical communications agencies provide critical support to clinical trial programs management through the following functions:

1. Precision in Clinical Trial Management & Documentation

Regulatory authorities such as the FDA (United States), EMA (Europe), and PMDA (Japan) require well-structured documentation for investigational drug approvals. Agencies like Turacoz Healthcare Solutions excel in developing and managing:

✔ Clinical Study Reports (CSRs)

✔ Investigator Brochures (IBs)

✔ Regulatory Dossiers (NDA/BLA Submissions)

✔ Common Technical Document (CTD) Modules

For instance, the approval of Enfortumab Vedotin (EV) for Urothelial Carcinoma was backed by robust clinical data meticulously documented for regulatory review (Powles et al., 2021).

2. Scientific Publications and Medical Writing

Publication planning ensures that pivotal clinical trial results reach global audiences through:

✔ Manuscripts for High-Impact Journals (e.g., The Lancet, JCO, NEJM)

✔ Conference Abstracts and Presentations (ASCO, ESMO, AUA, SUO)

✔ Systematic Literature Reviews and Meta-Analyses

For example, medical communications experts strategically publish Phase III trial data on androgen receptor inhibitors (apalutamide, darolutamide) in prostate cancer to ensure timely and credible dissemination.

3. Key Opinion Leader (KOL) Engagement & Advisory Boards

KOLs shape clinical practice and treatment guidelines. Medical communications agencies facilitate:

✔ KOL-Led Webinars and Roundtable Discussions

✔ Advisory Board Meetings for Trial Design Optimization

✔ Medical Education Programs for Oncologists and Urologists

A notable example is the KEYNOTE-564 trial, which established pembrolizumab as an adjuvant therapy for RCC. Effective KOL engagement helped drive physician awareness and adoption (Choueiri et al., 2021).

4. Data Visualization and Infographic Creation

Communicating complex clinical trial data phases in a digestible, engaging, and compliant manner is critical. Turacoz specializes in:

✔ Infographics Summarizing Clinical Trial Outcomes

✔ Patient-Friendly Educational Materials including informative ppt, pdf and journals

✔ Interactive Data PPT Presentations for Conferences

For example, in the era of real-world evidence (RWE) studies, agencies translate large datasets into visually impactful decision-support tools for clinicians.

5. Medical Affairs & Market Access Support

Beyond publications, medical communications agencies enhance health economics and outcomes research (HEOR) by:

✔ Developing Value Dossiers and Reimbursement Submissions

✔ Creating Plain Language Summaries for Patient Advocacy Groups

✔ Facilitating Payer Engagement Strategies

For instance, the cost-effectiveness of nivolumab for bladder cancer played a crucial role in reimbursement decisions, highlighting the importance of structured HEOR communication (Sharma et al., 2021).

Genitourinary Cancer Treatment medical communication services for oncology, cancer treatment of bladder, prostate
medical communication services for oncology, cancer treatment of bladder, prostate

Partnering with Turacoz ensures that breakthrough innovations in genitourinary oncology are accurately communicated, accelerating regulatory approvals, clinician adoption, and improved patient outcomes.

Conclusion

The treatment landscape for genitourinary cancers is evolving rapidly, making expert medical communication strategies essential to bridge the gap between scientific breakthroughs and clinical practice. By partnering with a specialized agency like Turacoz, pharmaceutical companies can optimize clinical trial success, regulatory submissions, and market access—ultimately improving patient care and outcomes.

References (Fact-Checked & Credibility Verified)

  • Sung, H., Ferlay, J., Siegel, R. L., Laversanne, M., Soerjomataram, I., Jemal, A., & Bray, F. (2021). Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA: A Cancer Journal for Clinicians, 71(3), 209-249. https://doi.org/10.3322/caac.21660
  • Siegel, R. L., Miller, K. D., & Jemal, A. (2023). Cancer statistics, 2023. CA: A Cancer Journal for Clinicians, 73(1), 17-48. https://doi.org/10.3322/caac.21763
  • Antoni, S., Ferlay, J., Soerjomataram, I., Znaor, A., & Jemal, A. (2017). Bladder cancer incidence and mortality: A global overview and recent trends. European Urology, 71(1), 96-108. https://doi.org/10.1016/j.eururo.2016.06.010
  • Capitanio, U., & Montorsi, F. (2016). Renal cancer. The Lancet, 387(10021), 894-906. https://doi.org/10.1016/S0140-6736(15)00046-X
  • Ghazarian, A. A., Trabert, B., Devesa, S. S., McGlynn, K. A., & Sakoda, L. C. (2017). Recent trends in the incidence of testicular germ cell tumors in the United States. Andrology, 5(1), 99-104. https://doi.org/10.1111/andr.12296
  • Powles, T., Rosenberg, J. E., & Sonpavde, G. (2021). Enfortumab vedotin in urothelial carcinoma. Nature Reviews Urology, 18(6), 357-358. https://doi.org/10.1038/s41585-021-00464-7

Choueiri, T. K., Powles, T., Burotto, M., & Escudier, B. (2021). Pembrolizumab as adjuvant therapy for renal-cell carcinoma. NEJM, 385(8), 683-694. https://doi.org/10.1056/NEJMoa2106391