Category Archives: Medical Writing

Top Benefits of Using Academic Research Writing Services

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“Write the paper as though no editor will ever see it … then let a good editor make sure everyone does.” — Anonymous Peer‑Reviewer

Introduction

In the era of hyper‑competitive research, scholars juggle with laboratory work, teaching loads, clinical duties, and an ever‑growing expectation to publish quickly. This demanding environment requires well-structured, clear writing with proper grammar and language quality. In the health‐sciences journals, a surveyed by Johnson & Miller (2023) reported that approximately one‑fifth of manuscript received first round rejections due to poor language quality.¹ As a result, many researchers turn to academic research writing services for professional support.

These services can amplify your productivity when it used transparently and within institutional policies,  without compromising authorship or academic integrity. Below we outline seven evidence‑backed benefits, the ethical safeguards you must observe, and practical tips for choosing the right provider.

  1. Save Time and Lower Stress
  • Drafting & structural editing free up hours during grant‑cycle crunches
  • Formatting & reference management eliminate repetitive tasks

A R01 applicant survey showed that outsourcing technical editing saved principal investigators a median of 7.5 hours per submission.²

  1. Access Field‑Specific Expertise

Reputable agencies recruit writers with advanced degrees (often PhDs or PharmDs) in specialties ranging from bioinformatics to nurse education. Their familiarity with discipline‑specific terminology, preferred reporting guidelines (e.g., PRISMA, CONSORT), and target‑journal scope improves the likelihood of favourable peer review.

  1. Ensure Technical & Regulatory Compliance

Professional editors keep abreast of style manuals (Vancouver, APA, AMA) and evolving journal requirements such as data‑sharing statements and graphical abstracts. A compliant manuscript avoids immediate desk rejection for formatting errors.

  1. Robust Plagiarism & Similarity Screening

Premium services run every draft through similarity‑detection suites (iThenticate, Turnitin) before you upload to the journal portal. You receive a similarity report along with guidance on legitimate paraphrasing and quotation.

  1. Comprehensive Research Support

Beyond writing, many firms offer:

  • Systematic literature searches (with librarian peer review)
  • Statistical analysis plans
  • Data‑visualisation assets
  • Response‑to‑reviewers letters

This end‑to‑end model streamlines the entire publication life‑cycle.

  1. Tailored Deliverables for Every Project

Whether you require a 300‑word conference abstract, an NIH R21 grant, or a 40‑page scoping review, services can scale and customise outputs to your word count, rubric, and journal guidelines.

  1. Collaborative Skill Development

Annotated edits, tracked‑changes files, and explanatory margin comments turn each project into a master‑class in academic writing. Over time, clients report noticeably clearer prose even when drafting solo.

Balanced Considerations & Ethical Safeguards

  1. Authorship Responsibility: Per ICMJE and COPE, authors must retain ownership of ideas, data, and final wording. Writing support does not equal authorship unless substantive intellectual contribution is added.
  2. Institutional Policies: Always confirm your university or funder permits external editorial services.
  3. Disclosure Statement: Good practice includes a note such as:

“Editorial assistance was provided by XYZ Medical Communications in accordance with journal policy; all authors approved the final manuscript.”

Final Thoughts

Academic research writing services, when used responsibly, can transform overwhelming writing tasks into efficient, high‑quality outputs—freeing you to focus on discovery, patient care, and teaching.

At Turacoz, we offer comprehensive Academic Research Writing Services designed to bridge the gap between brilliant research and compelling communication. Our commitment extends beyond mere editing—we partner with researchers to enhance clarity, ensure methodological rigor in presentation, and maintain the highest standards of academic integrity. Whether you’re navigating your first publication or seeking to accelerate your research output, our expert team stands ready to help transform your valuable insights into impactful, publication-ready manuscripts that advance both your career and your field of study.

References

  1. Johnson R, Miller C. Common reasons for manuscript rejection: an analysis of peer‑reviewers’ comments. J Schol Publishing. 2023;54(1):45‑56.
  2. Smith A, Gupta P. Time savings associated with professional editorial support during NIH grant preparation. Res Manage Review. 2022;37(2):125‑131.

World Thyroid Day 2025: How AI Is Revolutionizing Thyroid Health

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World Thyroid Day invites us to appreciate the tiny, butterfly-shaped gland with a big job in managing our body’s energy, growth, and mood. This year, the spotlight shifts to a very 21st-century ally, artificial intelligence (AI), and how it is reshaping the way clinicians detect, treat, and even prevent thyroid disorders such as hypothyroidism, hyperthyroidism, Graves’ disease, Hashimoto’s thyroiditis, thyroid nodules, and thyroid cancer.

 

AI in early detection: Who needs it the most

Machine-learning models trained on millions of electronic-health-record lines and lab reports can now flag people at risk of developing clinical thyroid disease months before the first symptom.1 A 2025 multicenter study built an interpretable ensemble model that accurately stratified heart-failure patients with co-existing thyroid dysfunction for one-year mortality and hospital-admission risk, outperforming conventional scores.2 By linking abnormal thyroid stimulating hormone (TSH) traces with age, comorbidities and medications, the system directs scarce clinic slots to those who need them most.

 

Diagnostic tools rebuilt around AI

Imaging: Deep-learning convolutional networks now review ultrasound videos, color-code suspicious tissue, and even render 3-D nodule maps on-the-fly. A study of 4569 cases found that the 3-Dimensional Total Nitrogen Visualization (3-D ‘TN Vis’) model, which was validated using data from seven hospitals, improved radiologists’ diagnostic accuracy by raising the area under the curve (AUC) from 0.66 to 0.79 and helped junior radiologists perform at the level of their senior colleagues.3 Another 2025 paper reported that “ThyroNet-X4 Genesis,” surpassed mainstream models in classifying sub-centimeter nodules.4

Blood-test interpretation: AI tools digest full thyroid panels – TSH, free T4/T3, antibodies – alongside “hidden” markers hidden in routine blood counts.

Pathology & molecular markers: Computer vision is also assisting cytologists reading fine needle aspiration slides and matching tumor genomes to targeted therapies. The same codebase that spots lung mutations now guide the choice of kinase inhibitors in regenerative medicine trials for recurrent thyroid cancer.

Remote monitoring: Wearables that track heart-rate variability and basal temperature can now feed AI predictors. In a 2023 cohort, resting-heart rate streams from smartwatches predicted thyrotoxic episodes with 86.14% sensitivity and 85.92% specificity, weeks before lab confirmation.5 For patients in rural areas, merging these data with tele-endocrinology portals means rapid dose tweaks without leaving home.

Limitations & Ethical Considerations of AI in Thyroid Care

While AI-driven tools promise faster detection and personalized management, several cautions remain.

  • Most commercial algorithms are trained on imaging and laboratory datasets derived from narrowly defined, often Western, populations. This can skew performance and increase the risk of missed or misclassified disease in underrepresented groups. Precise risk scores may also create false reassurance for low-risk patients or drive unnecessary procedures for those flagged as high-risk—unless clinicians interpret the outputs within the full clinical context.
  • On the privacy front, cloud-based ultrasound archives, wearable sensor feeds and integrated electronic health records aggregate highly sensitive data that must now meet India’s Digital Personal Data Protection (DPDP) Act, Health Insurance Portability and Accountability Act (HIPAA)/ General Data Protection Regulation (GDPR), and other regional regulations; security breaches in healthcare remain among the costliest of any sector.
  • Finally, many AI applications are still classed as software as a medical device and must clear Central Drugs Standard Control Organization (CDSCO) and FDA regulatory pathways before routine clinical use.

Ongoing prospective validation, algorithmic auditing, and explicit human oversight are therefore essential to translate impressive pilot results into safe, equitable real-world care.

Practical ways to observe World Thyroid Day

  1. Check your risk: Women over 30, anyone with autoimmune history, or those previously irradiated should ask for a TSH baseline
  2. Practice iodine-smart nutrition: Use iodized salt; eat seafood or dairy twice a week; discuss selenium or vitamin D status with your clinician
  3. Leverage digital tools: Connect a reputable thyroid-tracking app to your smartwatch and share the trends with your doctor for personalized dose adjustments
  4. Know the warning signs: Persistent fatigue, neck swelling or unexplained weight change warrant a thyroid panel—early self-awareness amplifies AI’s predictive power
  5. Spread the word: Share a factsheet, host a webinar, or post on social media using the hashtags #WorldThyroidDay and #ThyroidAwareness to boost public engagement

 

The road ahead

AI will not replace endocrinologists; it will empower them. Imagine chat-bots that guide newly diagnosed patients through lifestyle tweaks, or ultrasound probes that whisper malignancy scores during a scan. As datasets grow to include genomics, microbiome signals and environmental exposures, guidelines could evolve into continuously learning care paths, delivering precision medicine to the people living with thyroid disease.

On World Thyroid Day 2025, Turacoz celebrates not only the promise of silicon and code but also the power of informed citizens. By pairing innovative AI algorithms with classic public-health wisdom, we can ensure that the next decade marks a turning point in thyroid care.

References:

  1. Németh Á, Tóth G, Fülöp P, et al. Smart medical report: efficient detection of common and rare diseases on common blood tests. Frontiers in Digital Health. 2024 Dec 5;6:1505483.
  2. Iacoviello M, Santamato V, Pagano A, et al. Interpretable AI-driven multi-objective risk prediction in heart-failure patients with thyroid dysfunction. Front Digit Health. 2025;7:1583399.
  3. Zhou Y, Chen C, Yao J, et al. A deep learning-based ultrasound diagnostic tool driven by 3-D visualization of thyroid nodules. NPJ Digit Med. 2025;8:126.
  4. Santos-Silva MA, Sousa N, and Sousa JC. Artificial intelligence in routine blood tests. Front Med Eng (Lausanne). 2024;2:1369265.
  5. Shin K, Kim J, Park J, et al. A machine learning-assisted system to predict thyrotoxicosis using patients’ heart rate monitoring data: a retrospective cohort study. Sci Rep. 2023;13:21096.

How AI is redefining content creation in pharma — And why humans are still the drivers of trust

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In an era where speed, efficiency, and personalization have become imperatives, Artificial Intelligence (AI) — particularly machine learning, AI algorithms, and generative AI — is revolutionizing how the pharmaceutical industry approaches content creation. From automating reference linking to generating first drafts, AI is making content smarter, faster, and more scalable.

Yet, amidst this digital acceleration, one thing remains clear that human expertise is still the foundation of trust in healthcare communication.

At recent industry events and conferences, thought leaders echoed a common sentiment: AI is a catalyst, not a replacement. The most impactful pharma content today is born from a powerful synergy between AI and human intelligence, particularly when applied across disciplines such as data analysis, pharmacovigilance, clinical trials, and drug development.

 

The power of AI in pharma content creation

AI has significantly shortened the timeline of content development. By automating routine tasks like data architecture, extraction, summarization, and even modular content creation, AI enables teams to focus on higher-value activities. Some of the key advantages include:

  • Speed and efficiency: Drafting scientific summaries, creating modular content blocks, and auto-tagging assets for reuse — AI can perform these tasks in minutes, which previously took days.
  • Compliance and consistency: AI can cross-reference regulatory guidelines and validate claims faster, ensuring fewer errors and a higher level of consistency across materials.
  • Personalization at scale: Machine learning and AI algorithms help in tailoring content to specific audiences, ensuring that messaging is relevant, targeted, and timely – particularly in fields like personalized medicine and patient care.

The impact is undeniable. Pharma companies are no longer just creating more content — they are creating better content, delivered at the right time, to the right audience.

Why humans remain at the heart of trusted communications

Yet, even as AI transforms the operational side of content creation, human oversight remains indispensable for several reasons:

  1. Contextual accuracy and nuance

Medical communication is not just about relaying information — it’s about conveying it with precision, empathy, and context. AI can process data, but only humans can interpret complex medical nuances, drug discovery insights, and cultural considerations that shape the right narrative.

  1. Ethical and regulatory oversight

In the field of regulatory pharmalike pharmacovigilance and clinical trials, accuracy and ethics are non-negotiable. While AI can check references, it cannot assure about the ethical gray areas – a responsibility that remains with human experts.

  1. Building emotional connection

Trust in healthcare communications is deeply emotional. Physicians, patients, and stakeholders seek authenticity and human connection – something machines like large language models cannot replicate. Skilled writers infuse compassion, clarity, and credibility into every piece of content, building the trust that AI alone cannot establish.

  1. Innovation and strategic thinking

AI can optimize existing processes but cannot create disruptive strategies. Human creativity is still essential in commercial areas like customer engagement, content marketing, and long-term drug development strategies.

The future is Human + Machine, Not Human vs Machine

The future of pharma content creation lies in collaboration, not competition. AI — whether used in pharma AI tools, generative AI, or data analysis pipelines — should be seen as a powerful tool that augments human potential. When medical writers, regulatory experts, and creative strategists partner with AI, the result is content that is faster, smarter, and — most importantly — trusted.

At Turacoz, we believe that technology is only as powerful as the people who wield it. By combining the scalability of AI with the critical thinking, empathy, and expertise of humans, we help our clients craft communications that build lasting trust with healthcare professionals and patients alike.

Final thoughts

AI is redefining the way content is created in pharma, making processes smarter, faster, and more scalable — especially with advancements in AI algorithms, data architecture, and personalized medicine. But even the most sophisticated AI cannot replace the human touch that drives trust, credibility, and connection in healthcare communications.

As we embrace this exciting new era, the winning formula is clear: leverage the best of AI innovation, anchored by the irreplaceable value of human expertise.

Ready to elevate your content strategy with the perfect blend of human insight and AI innovation? Connect with Turacoz today.

World Thalassemia Day 2025: Giving a Voice to the Global Patient Community

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Every 8 May, World Thalassemia Day shines an international spotlight on the millions of people living with this inherited genetic disorder. The 2025 theme – “Together for Thalassaemia: Uniting Communities, Prioritising Patients” – captures the day’s core mission: to centre the patient, safeguard their rights, and ensure they are heard in every conversation about diagnosis, care, and cure.

Why patient voices matter

Thalassemia is more than severe anaemia or the frequent blood transfusions keep patient alive. It also means coping with fatigue, recurrent infections, painful splenomegaly, and the anxiety of waiting for a suitable bone marrow transplant. When patients share these everyday realities, they transform abstract epidemiology into human stories that resonate with policy‑makers, clinicians, and the public. Listening to patient experiences helps researchers design therapies that protect quality of life, not just haemoglobin levels, and reminds health systems that compassionate, patient‑centred care is a clinical imperative, not a luxury.

Awareness breeds early detection – and equity

World Thalassemia Day is the year’s biggest megaphone for public awareness. Broad campaigns that explain the difference between alpha and beta thalassemia, the role of genetic mutations, and the importance of early genetic counselling empower families to seek screening before the birth of an affected child. Awareness also normalises lifelong treatment – from iron‑chelation to emerging gene therapies – helping communities overcome stigma and misinformation. Crucially, it spotlights the wide gap in access to care between well‑resourced urban centres and low‑income regions where health inequalities still dictate life expectancy.

Patient advocacy: From individual struggle to collective power

Grass‑roots organisations turn individual stories into collective action. Their advocacy has expanded newborn screening programmes, secured government subsidies for transfusion supplies, and pressured insurers to cover expensive iron‑chelators. By partnering with scientific bodies, advocates elevate patient priorities on the global research agenda – accelerating healthcare innovation such as CRISPR‑based gene editing. This year’s theme urges deeper community engagement so local groups in Africa, South‑East Asia, and the Middle East can exchange strategies and unite around shared goals.

Public health policies that put patients first

No amount of patient courage can replace political will. World Thalassemia Day provides a rallying point for drafting evidence‑based public health and healthcare policies that guarantee timely transfusions, safe blood donation networks, and affordable chelation therapy. Advocates are calling for national guidelines that enshrine healthcare equality, fund specialised thalassemia centres, and subsidise cutting‑edge cures so that ability to pay never determines access to quality healthcare. Governments are also urged to adopt preventive measures—premarital carrier testing, public education on consanguinity risks, and school‑based disease prevention programmes—to curb the financial and emotional burden on future generations.

  • Donate blood – A single unit sustains a child with thalassemia for weeks.
  • Champion prevention – Encourage friends to seek carrier testing and pre‑marital genetic counselling.
  • Amplify stories – Share patient videos or blog posts on social media to shift the narrative from statistics to lived reality.
  • Support research funds – Philanthropy accelerates clinical trials for curative therapies and less invasive treatments.
  • Engage politicians – Write to representatives about the need for robust, patient‑friendly thalassemia legislation.

Looking ahead

World Thalassemia Day is more than a date on the calendar; it is a movement that refuses to let patients be passive recipients of care. By elevating their voices, the global community can drive healthcare access, reduce the financial burden of lifelong therapy, and ultimately fulfil the promise that no child will be barred from a healthy future because of an inherited blood disorder.

On this 8 May, Turacoz calls for the community support, systemic change, and truly person‑centred care reverberates far beyond a single day—until every patient, everywhere, is not just surviving, but thriving.

 

Decoding Ovarian Cancer Symptoms: Communicating the Silent Signs

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Ovarian cancer remains one of the most challenging gynaecologic malignancies, often referred to as a “silent killer” due to its subtle onset and late-stage diagnosis.1 In 2022, 324,603 women worldwide were diagnosed with ovarian cancer. By 2050, the annual incidence is projected to rise to nearly half a million, representing a 55% increase compared to current levels.² With over 200,000 lives lost globally in 2020, this disease continues to be a significant public health concern.3 The prognosis of ovarian cancer remains disappointing, with a mere 46% of women surviving beyond 5 years after diagnosis.3 Its ability to progress without clear early symptoms makes it particularly dangerous, but early detection can dramatically improve outcomes. A powerful ally in this effort—often underrecognized—is effective medical communication.

Why Early Detection Makes All the Difference

The statistics speak for themselves. Ovarian cancer that remains localized to the ovaries (stage I) has the potential to be effectively treated in as many as 90% of patients, whereas malignancy limited to the pelvic region (Stage II) correlates with a 5-year survival rate of 70%. Conversely, neoplastic disease that has disseminated beyond the confines of the pelvis (stage III-IV) exhibits a long-term survival probability of 20% or lower.4 This stark difference underscores the importance of timely diagnosis.

From a patient’s perspective, early detection can mean a less aggressive treatment course. In some cases, surgery alone may suffice, avoiding the physical and emotional toll of chemotherapy.5 For younger women, early intervention also opens the door to fertility-preserving options.6

From a provider’s standpoint, diagnosing the disease at an early stage facilitates more personalized care, reduces treatment complications, shortens hospital stays, and ultimately improves the quality of life for patients. Additionally, early-stage management is often more cost-effective and resource-efficient, which benefits the healthcare system as a whole.

The Challenge: Recognizing the Subtle Symptoms

One of the biggest hurdles in ovarian cancer care is identifying it early. The symptoms are often vague and easily mistaken for common digestive or urinary issues. But when these signs occur frequently—12 or more times a month—they shouldn’t be ignored.7

Watch out for:

  • Bloating or a swollen tummy
  • Pelvic or abdominal pain
  • Feeling full quickly or loss of appetite
  • Needing to urinate more often or urgently

Additional symptoms may include indigestion, unintentional weight loss, changes in bowel habits (constipation or diarrhoea), back pain, fatigue, and postmenopausal vaginal bleeding.7 Although these symptoms may be dismissed as minor or attributed to other causes, persistent occurrence warrants medical evaluation.

Who’s at Greater Risk?

Several risk factors further increase susceptibility, such as:8

  • Being over 50, particularly post-menopausal
  • Having BRCA1 or BRCA2 gene mutations
  • A family history of ovarian, breast, or colorectal cancer
  • A history of endometriosis
  • Never having been pregnant
  • Long-term use of hormone replacement therapy
  • Obesity

In individuals with these risk factors, proactive monitoring and timely screening become even more critical.

How is Ovarian Cancer Detected Early?

Unfortunately, there is no universally recommended screening test for ovarian cancer in asymptomatic women at average risk. However, several biomarkers and imaging tools are used—especially in high-risk individuals or when symptoms are present.

Key biomarkers encompass elevated levels of CA-125 (Cancer Antigen 125) and HE4 (Human Epididymis Protein). Diagnostic modalities like Risk of Ovarian Malignancy Algorithm (ROMA) integrates CA-125, HE4, and menopausal status to generate a risk score for malignancy, thereby facilitating the early detection of ovarian cancer. Furthermore, OVA1 test, a multivariate index assay, evaluates multiple protein levels in the blood to determine the risk of ovarian cancer in women presenting with an ovarian mass.8

There exist specific imaging tools that contribute to the early detection of ovarian cancer. Transvaginal ultrasound (TVUS) is instrumental in visualizing the ovaries and identifying abnormalities, such as masses or cysts, while pelvic MRI or CT scan may further assist in evaluation when ultrasound findings lack clarity.8

In women with familial predisposition to breast or ovarian cancer, genetic testing is crucial for the identification of BRCA1/2 mutations and other hereditary cancer syndromes linked to ovarian cancer. Understanding one’s genetic risk facilitates the implementation of preventive measures, including enhanced surveillance or prophylactic surgical interventions.8

Where Medical Communication Comes In?

While awareness of symptoms and risk factors is essential, medical communication serves as the cornerstone in bridging knowledge and action. Its role is multifaceted, benefitting both patients and healthcare providers.

Empowering Patients Through Education: When patients understand early signs of ovarian cancer, they’re more likely to seek care promptly. Campaigns like the CDC’s Inside Knowledge show that clear, accessible information leads to earlier recognition and action.9

Facilitating Early Diagnosis: Empathetic, attentive dialogue from healthcare providers encourages patients to report unusual symptoms, building trust and enabling earlier detection.

Enabling Shared Decision-Making: Clear, compassionate communication helps patients understand their diagnosis, explore treatment options, and actively participate in their care—improving both outcomes and satisfaction.

Overcoming Communication Barriers: Poor communication can delay diagnosis. Culturally sensitive, respectful interactions make patients feel safe, heard, and more likely to engage in their care.

Enhancing Screening and Prevention: Regular discussions about risk, symptoms, and family history motivate patients to adopt preventive behaviours and pursue early screening—critical for early-stage detection.

The Role of Medical Communication Agencies

At every stage—from raising awareness to supporting diagnosis, treatment decisions, and prevention—medical communication agencies act as strategic partners in improving outcomes. By transforming complex medical information into patient-friendly content, developing provider training tools, and designing culturally sensitive campaigns, these agencies ensure that critical health messages resonate. Their expertise in crafting clear, compassionate, and actionable communication bridges the gap between medical knowledge and patient engagement, ultimately driving earlier detection and better care experiences across the board.

Conclusion

Ovarian cancer remains challenging due to its silent onset and rapid progression, but early detection can shift outcomes dramatically. Medical communication is not just supportive—it’s a strategic enabler, driving awareness, encouraging timely symptom reporting, and building trust between patients and providers. As diagnostics advance, the impact of clear, compassionate communication remains vital in bridging the gap between symptom onset and timely intervention.

Turacoz specializes in in transforming complex medical information into clear, actionable content that supports both patients and healthcare providers. From developing symptom awareness tools to creating dialogue aids and educational campaigns, we enable early recognition, informed decision-making, and timely action. With expertise in oncology communication, we craft materials that foster trust, encourage preventive behaviour, and enhance patient-provider conversations—ultimately contributing to earlier detection and improved outcomes in ovarian cancer care.

References

  1. Feeney L, et al. Liquid biopsy in ovarian cancer: Catching the silent killer before it strikes. World J Clin Oncol. 2020;11(11):868-889.
  2. World Ovarian Cancer Coalition. Available at: https://worldovariancancercoalition.org/wp-content/uploads/2024/04/2024-Global-Priority.pdf. Last accessed: May 2025.
  3. Wang M, Bi Y, Jin Y, and Zheng ZJ. Global Incidence of Ovarian Cancer According to Histologic Subtype: A Population-Based Cancer Registry Study. JCO Glob Oncol. 2024;10:e2300393.
  4. Elias KM, Guo J, and Bast RC Jr. Early Detection of Ovarian Cancer. Hematol Oncol Clin North Am. 2018;32(6):903-914.
  5. Fishman DA and Bozorgi K. The scientific basis of early detection of epithelial ovarian cancer: the National Ovarian Cancer Early Detection Program (NOCEDP). Cancer Treat Res. 2002;107:3-28.
  6. Kim SY and Lee JR. Fertility preservation option in young women with ovarian cancer. Future Oncol. 2016 Jul;12(14):1695-8.
  7. Ovarian cancer. Available at: https://www.nhs.uk/conditions/ovarian-cancer/symptoms/. Last accessed: May 2025.
  8. Fernandes B. A Review on Emerging Biomarkers for Early Detection of Ovarian Cancer. Ind J Pharm Pract. 2024;17(1):17–20.
  9. Cooper CP, Polonec L, and Gelb CA. Women’s knowledge and awareness of gynecologic cancer: a multisite qualitative study in the United States. J Womens Health (Larchmt). 2011;20(4):517-524.

4 Ways in Which HEOR is Transforming Healthcare with RWE

Medical Publishing, Medical Writing,

The healthcare landscape is being reshaped at an unprecedented pace, powered by sophisticated data analytics, emerging technologies, and the escalating demand for real-world evidence (RWE). At the heart of this shift, Health Economics and Outcomes Research (HEOR) harnesses RWE to sharpen clinical decision-making, tailor treatment pathways, and elevate patient care. By embedding authentic, real-world insights into healthcare systems, HEOR is not just adapting to change — it is redefining the future of medical practice. Here’s how:

  1. Accelerating drug approval and access through real-world data

Bringing a new drug to market is a complex and highly scrutinized process. Traditional clinical trials, while essential, often have limitations, such as strict patient selection criteria that may not fully represent real-world populations. HEOR bridges this gap by utilizing RWE to offer a more comprehensive understanding of a drug’s effectiveness and safety across diverse patient groups.

For example, post-marketing RWE studies have been instrumental in demonstrating the long-term efficacy and safety of cancer drugs, helping pharmaceutical companies negotiate with regulators and payers for broader market access.1 By analyzing patient outcomes, healthcare resource utilization, and adherence patterns in real-world settings, HEOR strengthens the case for reimbursement and pricing strategies, ensuring that innovative treatments reach those who need them most.

  1. Driving value-based care and smarter reimbursement models

The shift from volume-based to value-based healthcare means that reimbursement is increasingly tied to patient outcomes rather than the quantity of services provided. HEOR, supported by RWE, plays a crucial role in assessing the cost-effectiveness and clinical benefits of medical interventions, leading to the adoption of value-based pricing models.

Payers and policymakers rely on HEOR data from sources like electronic health records (EHRs), insurance claims, and patient registries to determine whether treatments justify their costs. For instance, RWE analyses of diabetes treatments have influenced insurance providers to support outcome-based contracts, where reimbursement is tied to patient improvements rather than fixed pricing.2 This approach ensures that high-value treatments are rewarded, reducing inefficiencies and unnecessary healthcare spending.

  1. Personalizing care with precision insights from RWE

One of the most significant advances in modern medicine is the move toward personalized healthcare. HEOR, powered by RWE, helps identify patient subgroups that benefit most from specific treatments, enabling more targeted and individualized care strategies.

For example, RWE-driven HEOR studies have shown that certain genetic markers can predict a patient’s response to targeted cancer therapies, allowing oncologists to tailor treatment plans accordingly.3 This precision approach minimizes trial-and-error prescribing, reduces adverse events, and improves overall healthcare resource allocation. By aligning therapies with real-world patient data, HEOR enhances the efficiency and effectiveness of medical interventions, leading to better patient outcomes.

  1. Shaping public health strategies and improving population outcomes

Beyond individual care, HEOR and RWE provide essential insights for population health management and policy formulation. Governments and healthcare providers use this data to craft targeted interventions, address disparities, and respond to public health emergencies.

During the COVID-19 pandemic, HEOR-supported RWE helped evaluate vaccine efficacy across varied populations, guiding immunization strategies worldwide.4 With data-driven policymaking, healthcare systems can allocate resources more effectively and improve health outcomes on a broader scale.

Conclusion

At Turacoz, we aim to integrate HEOR and RWE is revolutionizing healthcare by delivering actionable insights that enhance drug development, refine reimbursement models, personalize treatment approaches, and inform public health strategies. As the healthcare landscape continues to evolve, the role of HEOR in leveraging real-world data will only grow, fostering a more efficient, evidence-driven, and patient-centered healthcare system.

With stakeholders across the healthcare spectrum embracing these advancements, we are moving toward a future where treatments are not only innovative but also accessible, cost-effective, and tailored to patient needs.

How is HEOR transforming healthcare in your region? Join the conversation.

 

References:

Dang A. Real-world evidence: a primer. Pharmaceutical medicine. 2023 Jan;37(1):25-36.

  1. Peasah SK, Huang Y, Palli SR, Swart ECS, Donato BMK, Pimple P, et al. Real-world impact of empagliflozin on total cost of care in adults with type 2 diabetes: Results from an outcomes-based agreement. J Manag Care Spec Pharm. 2023 Feb;29(2):152–60. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10387982/
  2. Agarwala V, Khozin S, Singal G, O’Connell C, Kuk D, Li G, et al. Real-world evidence in support of precision medicine: Clinico-genomic cancer data as a case study. Health Aff (Millwood). 2018 May;37(5):765–72. Available from: https://www.healthaffairs.org/doi/10.1377/hlthaff.2017.1579

EUPATI. Real-World Data (RWD) & Real-World Evidence (RWE). EUPATI Toolbox. 2025 Feb 19. Available from: https://toolbox.eupati.eu/resources/patient-toolbox/real-world-data-rwd-real-world-evidence-rwe/

The Role of HEOR in Payer Decisions to Switch from Originators to Biosimilars

Medical Publishing, Medical Writing,

Biosimilars—biologic medicines that are highly similar to FDA-approved originator biologics—offer a cost-effective alternative without compromising clinical efficacy.1,2 Since the first U.S. biosimilar approval in 2015, however, their market adoption has progressed more slowly than expected, despite a steady increase in FDA approvals and their proven safety and effectiveness.3,4 Payers have been cautious in fully embracing biosimilars, even though they are pivotal in reimbursement decisions and prescribing patterns. Understanding the barriers to biosimilar adoption and exploring how Health Economics and Outcomes Research (HEOR) can address these challenges is crucial for unlocking the full potential of biosimilars in transforming healthcare access and affordability.

Why Are Payers Hesitant to Adopt Biosimilars?

Several key challenges slow biosimilar adoption among payers:4

  • Lack of confidence in interchangeability: Payers often demand robust safety and efficacy data to feel comfortable substituting originators with biosimilars
  • Limited financial incentives: Without clear cost savings or reimbursement benefits, payers may not prioritize biosimilar uptake
  • Administrative burdens: Complex approval processes involved in switching the treatments can deter payers from encouraging biosimilar use

These concerns have created a cautious environment, slowing down the transition from originator biologics to biosimilars. This is where HEOR plays a pivotal role by generating comprehensive evidence that addresses payer concerns through cost-effectiveness analyses (CEA), budget impact models (BIMs), and real-world evidence (RWE).

How HEOR Supports Biosimilar Adoption

  1. Cost-Effectiveness Analysis (CEA)

The value of biosimilars, in comparison to originator biologics, can be assessed through CEA, which considers both their lower costs and comparable clinical efficacy.

For instance, CEA conducted in Canada for the treatment of metastatic colorectal cancer found that the biosimilars MVASI® and Zirabev® offered annual cost savings of €6379 compared to the originator drug, Avastin, without compromising survival outcomes. The study also supported the initial policy decision to mandate using bevacizumab biosimilars over the originator formulation. This approach helped reduce budget allocation toward bevacizumab and facilitated more efficient resource allocation while maintaining effective care.5 These savings highlight the potential for biosimilars to reduce healthcare expenditures without compromising patient outcomes.

  1. Budget Impact Models (BIMs)

While CEAs assess value, BIMs estimate the actual financial consequences of adopting biosimilars on healthcare systems. BIMs help payers understand potential cost savings and resource allocation implications, which are critical for reimbursement decisions.

The practical impact of BIMs is evident in several European countries. The introduction of biosimilar adalimumab and tocilizumab across seven European nations—including the UK, Germany, and France—was projected to yield cumulative savings of €462 million and enable treatment for an additional 65,593 patients.6 Similarly, a U.S. study on biosimilar adalimumab showed that faster conversion rates from originator to biosimilar led to greater savings, with cumulative savings reaching $28.8 million in a fast-conversion scenario.7 This demonstrates that not only the decision to adopt biosimilars but also the speed of adoption impacts financial outcomes.

  1. Real-World Evidence (RWE)

By leveraging RWE, researchers can better understand the clinical effectiveness and safety of biosimilars outside the structured environment of clinical trials. This data is crucial in building payer confidence by demonstrating that biosimilars perform similarly to originators in everyday clinical practice.

For instance, a real-world population-based study in British Columbia found no significant differences in healthcare resource utilization or clinical outcomes between biosimilar and originator etanercept users.8 This evidence helped underpin the province’s biosimilar switching policy. This policy dramatically increased biosimilar prescriptions: etanercept and infliximab biosimilar use rose by 76.98% and 58.43%, respectively. The switch generated substantial cost savings and improved patient access to biologic therapies without compromising safety or efficacy.9

How HEOR Influences Payer Decisions

HEOR evidence directly informs payer strategies in several ways:

Practical Influence

  • Cost Savings: Payers are motivated by the potential for significant cost reductions. For example, EU-5 markets saved €303.86 million with biosimilar rituximab.10 These savings can be reinvested to expand patient access or improve healthcare services.
  • Reimbursement Policies: HEOR informs the design of reimbursement frameworks, including price discounts, tendering processes, and mandatory switching policies. Countries like the UK and Germany have successfully implemented these strategies, which have been instrumental in driving biosimilar uptake.11,12

Theoretical Influence

  • Value-Based Healthcare: HEOR aligns with value-based healthcare principles by prioritizing interventions that deliver optimal outcomes at the lowest cost. Biosimilars exemplify this approach by reducing treatment costs without compromising quality.13
  • Policy Formation: Policymakers use HEOR findings to shape regulations encouraging biosimilar use. British Columbia’s biosimilar switching policy is a prime example, where evidence-based policy led to increased biosimilar uptake and substantial cost savings.9

Conclusion

In conclusion, as the healthcare system faces mounting pressures to deliver high-quality care while managing costs, adopting biosimilars stands out as a compelling opportunity that cannot be ignored. The collaborative efforts of regulators, payers, and providers, guided by robust HEOR evidence, are key to ensuring that the transition from originators to biosimilars is clinically sound and economically advantageous. HEOR has provided clear insights into cost-effectiveness, budget impact, and real-world performance, enabling payers to make informed decisions, optimize reimbursement strategies, and contribute to forward-thinking policy development. Ultimately, HEOR’s role in biosimilar adoption is not just supportive but transformative, paving the way for a more sustainable and accessible healthcare future.

References:

  1. Yang J, et al. Greater uptake, an alternative reimbursement methodology needed to realize cost-saving potential of oncology biosimilars in the United States. J Manag Care Spec Pharm. 2021;27(12):1642-1651.
  2. Mroczek DK, et al. Obstacles to Biosimilar Acceptance and Uptake in Oncology: A Review. JAMA Oncol. 2024;10(7):966-972.
  3. Shubow S, et al. Prescriber Perspectives on Biosimilar Adoption and Potential Role of Clinical Pharmacology: A Workshop Summary. Clin Pharmacol Ther. 2023;113(1):37-49.
  4. Edgar BS, et al. Overcoming barriers to biosimilar adoption: real-world perspectives from a national payer and provider initiative. J Manag Care Spec Pharm. 2021;27(8):1129-1135.
  5. Lu B, et al. Cost-Effectiveness Analysis of Bevacizumab Biosimilars Versus Originator Bevacizumab for Metastatic Colorectal Cancer: A Comparative Study Using Real-World Data. Value Health. 2024;27(12):1689-1697.
  6. Shastri K, et al. AB1428 Adalimumab and Tocilizumab Biosimilars in Europe: Budget-impact and Opportunity for Expanded Patient Access. Ann Rheum Dis. 2024;83:2069-70.
  7. Chaplin S, et al. Budget impact analysis of including biosimilar adalimumab on formulary: A United States payer perspective. J Manag Care Spec Pharm. 2024;30(11):1226-1238.
  8. Lacaille D, et al. POS0874 Comparable Safety and Effectiveness Among New Users of Biosimilar vs Originator Anti-NFTs in Inflammatory Arthritis: Population-based Evidence From a Policy Change. Ann Rheum Dis.;83:595-6.
  9. McClean AR, et al. Uptake and Spending on Biosimilar Infliximab and Etanercept After New Start and Switching Policies in Canada: An Interrupted Time Series Analysis. Arthritis Care Res (Hoboken). 2023;75(9):2011-2021.
  10. Jang M, Simoens S, and Kwon T. Budget Impact Analysis of the Introduction of Rituximab and Trastuzumab Intravenous Biosimilars to EU-5 Markets. BioDrugs. 2021;35(1):89-101.
  11. Zhang W, et al.
  12. Machado S, et al. Policy measures and instruments used in European countries to increase biosimilar uptake: a systematic review. Front Public Health. 2024;12:1263472.
  13. Chen HH, Yemeke T, and Ozawa S. Reduction of biologic pricing following biosimilar introduction: Analysis across 57 countries and regions, 2012-19. PLoS One. 2024;19(6):e0304851.

Content’s Industrial Revolution: Shaping the Future of Pharma

Medical Publishing, Medical Writing,

Communications

In a rapidly evolving digital ecosystem, the pharmaceutical industry’s relationship with content is undergoing a seismic shift. At the recent Reuters Pharma event in Barcelona, Dr. Namrata, Founder of Turacoz, led a thought-provoking panel discussion titled ‘Content’s Industrial Revolution’. The dialogue explored how content in pharma is undergoing a transformation driven by technology, collaboration, and an evolving mindset.

This transformation isn’t just about producing more content – it’s about producing smarter content that is personalized, compliant, and delivered at speed and scale. Here are the key takeaways that highlight how pharma companies can adapt to this revolution.

From linear to circular: Rethinking the content supply chain

Traditionally, the content supply chain in pharma has been linear – ideation, creation, review, and deployment. But the industry is waking up to a powerful realization: a circular content supply chain is the way forward. This means insights from content consumption must loop back into content creation.

It’s about listening, learning, and evolving continuously. When feedback and performance metrics inform the next content iteration, the result is more relevant, targeted, and effective communication.

Upfront partnerships: Shifting left in the review process

Another game-changing approach discussed in the panel was the concept of “shifting left” – engaging reviewers early in the content lifecycle. Instead of waiting until the end of the process for medical, legal, and regulatory (MLR) reviews, involving them upfront leads to fewer iterations and a higher rate of getting content right the first time. “Involving reviewers early and leveraging AI is no longer optional—it’s the only way to create content that’s both fast and flawless,” noted Dr. Namrata during the panel. This proactive alignment improves efficiency, saves time, and ensures clarity from the start.

AI and GenAI in Action: Smarter, Faster, Compliant

Nearly 80% of pharma companies are now embedding AI into their content workflows.1 The path forward lies in industrialization—standardizing content processes to eliminate duplication and reduce costs. This includes:

  • Tiered review systems based on content similarity
  • Modular content structures for reuse and recycling
  • AI-led automation for reference linking and claims validation

 These innovations reduce manual effort and error, speed up reviews and improve compliance and traceability.

Reduce, reuse, recycle: Sustainable content practices

Content sustainability is now a business imperative. Strategies like modular content creation, centralized digital libraries, and approved content recycling help reduce production time and content fatigue—while ensuring consistency across global teams.

Let’s break down what reduce, reuse, and recycle means in the pharma content world:

  • Reduce
    Minimize duplication by avoiding the creation of redundant content. Use centralized libraries and templates to streamline creation and approval processes.
  • Reuse
    Build modular content blocks that can be repurposed across different channels, regions, and campaigns. One approved module (e.g., a product description) can be reused in emails, websites, and brochures.
  • Recycle
    Refresh and repackage existing high-performing content instead of always starting from scratch. This ensures content stays relevant and reduces production time.

These sustainable practices improve efficiency, maintain global consistency, and cut down costs.

Mindset, toolset, and skillset: The three pillars of change

Technology is only part of the equation. To truly embrace this revolution, organizations need the right:

  • Mindset: Be curious, open to learning, and willing to fail fast
  • Toolset: Adopt tech that enables agility without sacrificing compliance
  • Skillset: Invest in training and upskilling teams for the future of content

Internal and external collaboration will be the glue that holds these pillars together ensuring that strategy, execution, and innovation move in sync.

Human + Machine: A balanced equation

While technology is a powerful enabler, the human touch remains irreplaceable. Keeping humans in the loop ensures contextual accuracy, emotional intelligence, and ethical responsibility especially critical in healthcare communications. The goal is to strike the right balance between automation and human oversight.

Final thoughts

As the content landscape shifts from volume to value, pharma companies need to focus on crafting impactful content that resonates with the audience. This means not just doing things faster but doing them better – with clarity, compliance, and compassion.

At Turacoz, we are proud to be at the forefront of this transformation, driving change that empowers our clients to communicate with precision and purpose. The content revolution is here—and we’re ready to lead it.

Ready to transform your content strategy? Connect with Turacoz to explore how we can help you scale smarter.

Reference:

Kudumala A, Konersmann T, Israel A, Miranda W. Biopharma digital transformation: Gain an edge with leapfrog digital innovation. Deloitte Insights. 2021 Dec 8. Available from: https://www2.deloitte.com/us/en/insights/industry/life-sciences/biopharma-digital-transformation.html​

Health Journalism: Combating Misinformation with Accuracy

Medical Devices, Medical Publishing, Medical Writing,

By Turacoz Healthcare Solutions | World Liver Day 2025

In a world where social media dominates wellness discussions, liver health is a popular topic — albeit not always a well-informed one. From miracle cures to detox diets, the liver is the focus of myriad health claims with little scientific basis. On this World Liver Day, we highlight the vital role of health journalism in separating fact from fiction and delivering accurate, science-based information.

Emergence of Misinformation about Liver Health

Digital media have opened health information to everyone—but with such openness comes an influx of unfiltered information. Wellness bloggers, often with little to no medical training, tout liver ‘cleanses’ and ‘superfoods’ without accountability. These messages, though alluring, can mislead consumers, undermine patient education campaigns, and jeopardize liver health.

False information not only causes confusion but also can delay treatment and accurate diagnosis. With early treatment being essential in conditions such as non-alcoholic fatty liver disease (NAFLD), hepatitis, and cirrhosis, patients are at a loss if discussion centers around misinformation.

The Role of Health Journalism in Public Health

Evidence-based health journalism acts as a link between health practitioners and the general population. Accurate, accessible, and understandable health reporting translates complex medical jargon into clear messages, enhancing health literacy and supporting informed decision-making.

Medical writers and journalists have an obligation to:

  • Confirm information from evidence-based sources like peer-reviewed journals and clinical practice guidelines.
  • Work with specialists such as hepatologists, nutritionists, and scientists.
  • Employ health information management systems to track, interpret, and share accurate data.

Fact-checking in the Social Media era

With misinformation traveling at lightning speed on the internet, fact-checking now forms a bedrock of trustworthy health communication. Using health information technology like automated content verification systems and AI-based surveillance, medical communicators can quickly address misleading claims and disseminate accurate content to the masses.

Agencies, along with journalists, should also predict patterns. Tracking social media discussions enables them to correct misleading reports in a timely fashion and present scientifically correct counter-information.

Empowering Patients Through Education

Correct health information not only educates, it empowers. Liver health education should be centered in useful, actionable information: comprehending liver function, identifying risks, adopting evidence-based dietary practices, and recognizing warning signs that necessitate medical care.

By ensuring that educational resources are synchronized with national health goals and governmental standards, medical communicators contribute effectively to national campaigns promoting liver health.

A Partnership with Health Professionals

Effective health journalism does not exist in a vacuum. It is developed in close collaboration with health professionals, patient advocacy organizations, and public health organizations. Such collaborations help guarantee that information is up to date, applicable, and consistent with clinical best practices.

The way forward

Combating misinformation on matters related to the liver necessitates a multifaceted approach:

In Conclusion

Being a trusted medical communications agency, Turacoz is of the opinion that science-based, accessible, and honest communication is central to improved health outcomes. On this World Liver Day, we reaffirm our values of truth, science, and service—because timely information is a matter of saving people’s lives.

 

Patient Voices Matter: How Patient-reported Outcomes Are Redefining Market Access

Medical Devices, Medical Publishing, Medical Writing,

The healthcare industry is experiencing a paradigm shift as patient voices take center stage in drug development and approval processes. While clinical trial data continues to be the cornerstone of drug development and approval, patient-reported outcomes (PROs) are emerging as the gold standard for demonstrating real-world value, particularly when it comes to market access approvals offering valuable insights into the patient experience and treatment impact. As healthcare systems worldwide shift toward value-based care, PROs are getting more and more widely used in clinical trials and approval processes. For example, the proportion of industry-sponsored oncology trials including PROs assessments rose from 26% (2007–2013) to 75% (2014–2018).1 This increased integration of PROs into clinical trials and regulatory submissions reflects a growing acknowledgment of their value in evaluating therapies from the patient’s perspective.

The Evolution of Healthcare Metrics

Historically, drug approvals focused primarily on “hard” clinical endpoints, while these metrics remain important, they tell only part of the story, and do not completely capture the picture of quality of life (QoL) or daily functioning. PROs that reflect the patient’s direct perspective on their symptoms, functional status, and overall well-being capture this crucial dimension that clinical data alone cannot measure complementing the traditional clinical outcomes. This holistic view of treatment effects is particularly important for chronic and debilitating conditions, where symptom burden and QoL are critical determinants of treatment success.2,3

Regulatory Recognition

Regulatory bodies worldwide have recognized this gap and are increasingly demanding PRO data as part of approval submissions:

  • The U.S. Food and Drug Administration (FDA)1 has established Patient-Focused Drug Development (PFDD) to encourages patient participation in R&D decision-making process with an aim to develop a drug which better meets the patients’ needs. PROs were included in FDA’s 53% of medical device authorizations.4
  • The EMA’s regulatory guidance explicitly recommends PROs inclusion for many therapeutic areas. For example, 78.1% of oncology approvals by EMA included PROs.5
  • Health technology assessment (HTA) bodies and reimbursement agencies are leveraging PROs to evaluate the value of treatments in real-world settings. This trend is supported by studies showing that PROs can identify low-value care and inform cost-effectiveness analyses, thereby optimizing resource allocation in healthcare systems.6 

The increasing integration of PROs into regulatory submissions underlines their significance in demonstrating treatment benefits from a patient perspective.

The Market Access Imperative

For pharmaceutical companies PRO data is becoming essential for market access success. Here’s why:

Differentiation in Crowded Markets

PRO data can help to distinguish therapies, especially in oncology post-progression scenarios. A study has indicated that positive PRO data such as superior symptom relief, improved physical functioning support continued therapy at the physician’s discretion upon regulatory approval, even in progressive disease.7

Pricing and Reimbursement Leverage

The U.S. healthcare system is shifting from fee-for-service to value-based payment models to enhance patient care quality and control costs. Under the 2015 Medicare Access and Children’s Health Insurance Program Reauthorization Act, providers will be assessed on quality and cost efficiency, affecting their reimbursement rates. PROs play a key role in this transition by offering insights into patient preferences, experiences, and perceptions of benefits and risks. These insights inform pricing, reimbursement, and benefit-risk assessments, ensuring treatments align with patient values. PROs also influence health technology assessments by evaluating the impact of medical technologies on quality of life, guiding more equitable pricing decisions based on what patients value.8,9

Formulary Placement and Treatment Guidelines

Clinical practice guidelines are giving greater weight to PROs evidence when making recommendations. For example, European Society for Medical Oncology (ESMO) recommends symptom monitoring using patient-reported outcome measures (PROMs) for patients with stage IIIB/IV lung cancer who have completed initial or maintenance treatment. Additionally, it also recommends PROMs in survivorship care of patients after treatment of cancer, to improve communication and identify late toxicities, symptoms or functional impairment warranting supportive care.10

Beyond regulatory initiatives, incorporating PROs can increase the “value” of your therapeutic from a payor perspective, ultimately helping formulary placement.11

Advances in Digital Data Collection Have Made Collecting PROs Easy

The advent of digital health technologies has facilitated the collection and analysis of PROs, making them more accessible and actionable. Electronic patient-reported outcome measures (ePROMs) enable real-time data capture, reducing barriers to implementation and improving the quality of PRO data.6,12  For example, digital platforms are being used to collect PROs in large-scale studies, such as the PROMchronic study in Germany, which aims to evaluate the effectiveness of ePROMs in improving care for patients with chronic diseases like diabetes and asthma.6 Additionally, AI and machine learning help analyze PRO data to identify patterns and insights.

Challenges and Opportunities

Despite their growing importance, the use of PROs in market access approvals is not without challenges. Issues such as the lack of standardization, variability in data quality, and the need for robust methodologies remain. However, ongoing research and policy initiatives are addressing these challenges, with a focus on developing validated instruments, improving data collection practices, and integrating PROs into regulatory frameworks.13,14

For example, the European Medicines Agency (EMA) has emphasized the need for harmonization of PRO measures to facilitate their use in drug development and regulatory decision-making. Similarly, initiatives like the Innovative Medicines Initiative (IMI) PREFER project are working to establish best practices for incorporating patient preferences into regulatory evaluations.14,15

The Future of PROs in Market Access

The future of PROs in market access approvals is promising, with ongoing advancements in technology, policy, and methodology. As regulators and payers increasingly recognize the value of patient-centered data, PROs are likely to become even more integral to healthcare decision-making. Their ability to capture the patient’s perspective, complement traditional outcomes, and support real-world evidence makes them indispensable in the era of value-based healthcare.16

Conclusion

In conclusion, PROs are becoming the gold standard for market access approvals because they provide a patient-centered perspective, complement traditional clinical outcomes, and support regulatory and reimbursement decisions with real-world evidence. As healthcare systems continue to evolve, the integration of PROs into decision-making processes will remain a cornerstone of value-based, patient-centered care.

References

  1. Cao K, et al. From the Formation of Conceptual Framework to Regulatory Decision-Making: Considerations for the Developments of Patient-Reported Outcome Instruments. Drug Des Devel Ther. 2024;18:5759-5771.
  2. Bonsel JM, et al. The use of patient-reported outcome measures to improve patient-related outcomes – a systematic review. Health Qual Life Outcomes. 2024;22(1):101.
  3. Jeyaraman N, et al. Voices that matter: The impact of patient-reported outcome measures on clinical decision-making. World J Methodol.2025; 15(2):98066.
  4. Matts ST, et al. Inclusion of patient-reported outcome instruments in US FDA medical device marketing authorizations. J Patient Rep Outcomes. 2022;6(1):38.
  5. Teixeira MM, et al. A review of patient-reported outcomes used for regulatory approval of oncology medicinal products in the European Union between 2017 and 2020. Front Med (Lausanne). 2022;9:968272.
  6. Nikkhah J, et al. Evaluating the Population-Based Usage and Benefit of Digitally Collected Patient-Reported Outcomes and Experiences in Patients With Chronic Diseases: The PROMchronic Study Protocol. JMIR Res Protoc. 2024;13:e56487.
  7. Brogan AP, et al. Payer Perspectives on Patient-Reported Outcomes in Health Care Decision Making: Oncology Examples. J Manag Care Spec Pharm. 2017;23(2):125-134.
  8. Chachoua L, et al. Use of Patient Preference Information in Benefit-Risk Assessment, Health Technology Assessment, and Pricing and Reimbursement Decisions: A Systematic Literature Review of Attempts and Initiatives. Front Med (Lausanne). 2020;7:543046.
  9. Squitieri L, Bozic KJ, and Pusic AL. The Role of Patient-Reported Outcome Measures in Value-Based Payment Reform. Value Health. 2017;20(6):834-836.
  10. Di Maio M, et al. The role of patient-reported outcome measures in the continuum of cancer clinical care: ESMO Clinical Practice Guideline. Ann Oncol. 2022;33(9):878-892.
  11. Oderda G, et al. Payer perceptions on the use of patient-reported outcomes in oncology decision making. J Manag Care Spec Pharm. 2022;28(2):188-195.
  12. Joeris A, et al. Real-world patient data: Can they support decision making and patient engagement?. Injury. 2023;54 Suppl 3:S51-S56.
  13. Almeida D, et al. Leveraging patient experience data to guide medicines development, regulation, access decisions and clinical care in the EU. Front Med (Lausanne). 2024;11:1408636.
  14. Janssens R, et al. How can patient preferences be used and communicated in the regulatory evaluation of medicinal products? Findings and recommendations from IMI PREFER and call to action. Front Pharmacol. 2023;14:1192770.
  15. Ciani O, et al. Patient-reported outcome measures in drugs for neurological conditions approved by European Medicines Agency 2017-2022. Neurol Sci. 2023;44(8):2933-2937.
  16. Adeghe EP, Okolo CA, and Ojeyinka OT. The influence of patient-reported outcome measures on healthcare delivery: A review of methodologies and applications. OARJBP. 2024;10(2):013-21.