Tag Archives: #THS

Role of a Medical Writer in Publication Documents

Medical Writing, , , , , , , ,

Background

Writing is a medium of human communication to express one’s thinking in easily understandable but effective way. The strength of writing is displayed by its knowledge-transforming effects. Knowledge is vital at every stage of research-based endeavours in basic research, clinical research, drug development lifecycle, drug approvals, phases of clinical trials, and post-marketing research.  At each stage, this knowledge is passed on in writing to communicate the findings of research to the scientific community, clinicians, regulators as well as public.

Importance of publication

Publishing biomedical research, in the form of case reports, original articles, literature reviews etc. in peer-reviewed journals, is important. Doing so, augments understanding of health, diseases and their management, drug risks and benefits, and helps to improve medical practice benefitting the patients, health community and society at large.

Reasons to not publish

However, despite the fact that most clinicians and researchers understand the need to publish their work, this task may prove challenging to them because of various reasons including lack of time to write and submit, inadequate data analysis support and technical writing expertise, and lack of knowledge of publication practices and guidelines (1).  But, we all understand and admit that scientific information can be difficult to read and to comprehend. A poorly written information could easily confuse the reader and leave the audience misinformed. For these reasons, numerous papers are rejected by top peer-reviewed journals.

Medical Writing services

Medical writing is communication of scientific and clinical information in a clear, accurate, unbiased, and logical way to a specific set of target audiences such as clinicians, healthcare professionals, regulators, scientists, patients, and general public. This includes the preparation of different types of documents: Regulatory (e.g. clinical trial protocols, clinical study reports, investigator’s brochures, new drug applications, research proposals, informed consent documents); Publications (e.g. original articles, literature reviews, case reports, editorials, abstracts for conferences); Medical education (e.g. posters, continuing medical education (CME), e-learning modules, slide decks for meetings, brochures and internet content for physicians and patients); and Medico-marketing (e.g. literature for product promotion) (5).

Medical Writing – need and demand

There’s pressing need for effective presentation and dissemination of knowledge to accelerate publishing and decision-making in healthcare. Supporting this, a Portuguese report highlighted the importance of medical writing skills for successful publishing in top-rated journals (2). Furthermore, according to a report, global demand for medical writing market was valued at approximately USD 2.03 billion in 2018 and is expected to generate a revenue of around USD 2.95 billion by the end of 2025 (3). Even in India, the medical writing industry is on an upward growth path (4).

Medical Writer – skills and role in publication

Researchers and clinicians may be best at their jobs, but they may not necessarily have the skills to present their data in an effective manner. A medical writer (MW) is a scientific writing and editing expert with an advanced degree in biomedical sciences (e.g. MBBS, PhD) and robust understanding of biomedical and clinical research, reporting guidelines and publication practices such as ICH, ICJME, GPPs, CONSORT (6). He/she would possess substantial data analysis skills to be able to summarise and present even the most complex clinical research data in a coherent manner. This helps the researchers to achieve objectives such as getting their work published in a respected journal, receiving funding for research projects or finding acceptance of their work by their professional peers.

Therefore, the documents prepared with the support of medical writers are less likely to get rejected or retracted by the peer-reviewed journals as they adhere to the reporting and publication guidelines specified by the journals. Such documents are accepted for publication quickly as good writing fastens the review process as compared to the ones without any such support (7). All this suggests that a MW makes a substantial contribution towards a good quality research publication. In addition to providing writing assistance, a MW advise on the right journals for an article and offer support for editing, journal styling and submitting the manuscript for publication (Figure 1).

A MW has the ability to model his/her writing in terms of most suitable language and level of technical information depending on the target audience. For instance, the documents entitled for medical professionals usually include detailed clinical information or data while the ones intended for common people are in simple language and free of core scientific details. In regulatory writing, a MW is well aware of the prescribed formats and regulatory guidelines to be strictly followed in order to produce the high-quality documents.

MWs are not involved in the conception, design or execution of clinical research, so they are not listed as authors, but their contributions are mentioned in the acknowledgments section of the manuscript (8).

Conclusion

Clear, logical, and accurate writing reinforces the dissemination of reliable research information through good quality publications to varied target audience. MWs play an important role to speed up the publication process to meet the growing need for high-quality, timely publications. Clear understanding of the role of a medical writer in publication development will pave the way for their appropriate use by clinicians and scientists to communicate their research findings to the scientific community.

The Medical Writers at Turacoz Healthcare Solutions (THS) understand and abide by the reporting guidelines and publication practices such as ICH, ICJME, GPPs, CONSORT to deliver high-quality documents communicating scientific and clinical information. Turacoz is a medical communications company, which offers services to healthcare professionals in clinical research, regulatory writing, publication writing, medico-marketing writing, and support for conducting medical advisory board meetings.

If you have any queries, email us at [email protected].

References

  1. Sharma S. Professional medical writing support: The need of the day. Perspectives in clinical research 2018; 9:111-112.
  2. Marinho RT, Donato H, Fernandez-Llimos F, Massano J, Silva JM, Almeida M, et al. Think Tank: Relatório estratégico sobre publicação científica biomédica em Portugal. Acta Med Port. 2014;27:1-3.
  3. Global Industry Perspective, Comprehensive Analysis and Forecast, 2019 – 2025. Available from: https://www.zionmarketresearch.com/report/medical-writing-market. Accessed on 15 July 2020.
  4. Shirke S. Medical writing on an accelerated path in India. Perspect Clin Res. 2015;6:125-128.
  5. Bissau J, Borrego P. Professional medical writing: A tool for high quality publications. Acta Med Port. 2015;28:545–7.
  6. Das N, Das S. Hiring a professional medical writer: is it equivalent to ghostwriting? Biochem Med. 2014;24:19-24.
  7. Wager E, Woolley K, Adshead V, Cairns A, Fullam J, Gonzalez J, et al. Awareness and enforcement of guidelines for publishing industry-sponsored medical research among publication professionals: the Global Publication Survey. BMJ Open. 2014;4:e004780.
  8. Angela Stocks, Donna Simcoe, Dikran Toroser & Lisa DeTora. Substantial contribution and accountability: best authorship practices for medical writers in biomedical publications. Current Medical Research and Opinion 2018;34:1163-1168.

Good Clinical Practice Guidelines by WHO

Clinical Trials, , , ,

Good Clinical Research Practice (GCP) is an established international ethical and scientific quality standard process for the design, conduct, performance, auditing, monitoring, recording, analysis, and reporting of clinical studies. GCP ensures that the reported data and results are credible and accurate, and the rights integrity and confidentiality of study subjects are respected and protected. All the stakeholders must adhere to the GCP standards including research subjects, sponsors, investigators, contract research organizations (CROs), site staff, ethics committees, and regulatory authorities.

Goals of Good Clinical Practice

The GCP is established with the following aims:

  • To protect the rights,safety, and wellbeing of humans involved in research
  • To assure the accuracy, reliability, quality and integrity of data collected
  • To provide standards and guidelines for a well-conducted clinical research
  • To speed up the marketing and promotion of new products
  • To ensure benefit to both sponsors and consumers by reducing the cost of trial and investigation products.

Figure 1: Goals of GCP

Compliance of GCP assures public that the safety,rights and well-being of human subjects involved in research are protected and are consistent with the principles stated in the Declaration of Helsinki and other internationally recognized ethical guidelines.

Foundations for Ethical Conduct

Declaration of Helsinki

Declaration of Helsinki (1964) was developed as a statement of ethical principles to guide physicians and other participants in medical research involving human subjects.

The other foundations for the ethical conduct of clinical research include:

  • The Nuremberg Code (1947): After the second world war, Nuremberg trials of war criminals resulted into introduction of 10 elements of medical ethics, known as ‘Nuremberg Code’, in August 1947, to protect human subjects from cruelty and exploitation while conducting human experiments.
  • The Belmont Report (1979): As a result of National Research Act of 1974, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research had written ‘The Belmont Report’. It was created to identify the basic ethical principles for the conduct of biomedical and behavioral research involving humans and develop guidelines to make sure that the research is conducted in accordance with the principles.
  • International Conference on Harmonization (ICH-GCP): ICH provided the international quality standard to harmonize technical procedures and standards, enhance quality and accelerate time to market.
  • International Standards Organization (ISO): ISO 14155:2011 developed international standards to protect the rights, wellbeing and safety of human subjects, ensure the accuracy and reliability of results, define the responsibilities of sponsorsand clinical investigators, and assist sponsors, investigators, regulatory authorities, ethics committees, and others involved in the conformity assessment of medical devices.
  • Code of Federal Regulations (CFR): CFR is the codification rules and regulations published in the Federal Register by the federal government of the United States. The CFR includes FDA regulations on human subject protection and the conduct of clinical studies.

Background

WHO organized a ‘Scientific Group on Principles for Clinical Evaluation of Drugs’ in 1968 and then in 1975 to review and formulate principles and guidelines for clinical evaluation of drugs, new indications or dosage forms for marketed drug products and new combination products, and covering all aspects of drug development.In 1995,the WHO published ‘Guidelines for good clinical practice for trials on pharmaceutical products’ based on these reports.

WHO Principles of GCP

There are 14 principles of WHO GCP and are summarized as follows:

Principle 1 –Ethical Conduct: All clinical trials must adhere to basic ethical principles which have their origin in the Declaration of Helsinki, namely equal importance for persons, beneficence, and justice, permeate all other GCP principles.

Principle 2 –Protocol: A detailed, clear protocol including background, rationale, objective(s), design, methodology, statistical considerations, information, and organization of a trial should be laid out for every clinical research involving human subjects and comply with scientific standards.

Principle 3 – Risk Identification: Beforea study/trial is initiated, all foreseeable inconveniences and risks should be assessed against the estimated benefit(s)for the individual trial subject and society. A proposed clinical trial should be supported by sufficient non-clinical and clinical information for source of information, knowledge of literature, and on adequate lab, and where applicable, animal experimentation.

Principle 4: Benefit-Risk Assessment: Trial with human subjects should be initiated and continued only if the predicted benefits outweigh the risks for the individual and society. The safety and well being of the trial subjects should be considered most important over the interest of science and society.

Principle 5 – Review By IEC/IRB:A protocol review of a clinical trial involving humans,should be submitted for consideration, guidance, evaluation, comments, and approval by specially appointed independent ethics committee/institutional review board (IEC/IRB).

Principle 6 – Protocol Compliance: Research with humans should be well-conducted in compliance with the protocol after approval by IEC/IRB. Any deviation or changes of the protocol shouldn’t be applied by the investigator without the sponsor’s agreement and documented approval/favorable opinion by IEC/IRB.

PRINCIPLE 7 – Informed Consent: A freely provided informed consent from each human subject before participation in any clinical trial should be obtained in compliance with the national culture(s) and requirements. The subjects should volunteer as informed participants. If giving informed consent is not possible for any subject, a legally authorized representative should give permission,by applicable law.

Principle 8 – Continuing Review/Ongoing Benefit-Risk Assessment: Clinical trials having humans as research subjects should be continued only if the benefit-risk assessment remains favorable. The sponsors should ensure a process to assess and evaluate the drug development continuously during the clinical trial. The ethics committee should conduct reviews during the research and monitor its progress.

Principle 9 – Investigator Qualifications: On behalf of the trial subjects, the decisions and medical care should be made by a qualified and duly licensed medical professional, i.e., physician or, when appropriate, a dentist.

Principle 10 – Staff Qualifications: Every individual who is involved in directing a trial must be qualified by training, education, and experience to perform their respective task. This includes the investigator and his/her supporting staff to assist him.

Principle 11 – Records: All the information during the clinical trial should be recorded, handled, and stored in a way to allows accuracy in its interpretation, reporting, maintenance, and verification.

Principle 12 –Confidentiality/Privacy: The confidentiality of records that could identify subjects must be protected, respecting the privacy and confidentiality rules in compliance with the applicable regulations This is done to safeguard the integrity of subjects.

Principle 13 – Good Manufacturing Practice (GMP): Manufacturing, handling, and storage of investigational product(s) should be in accordance with applicable GMP and should be used in accordance with the approved protocol.

Principle 14 – Quality Systems: Systems with procedures that assure the control assure and improve the quality of every aspect of the clinical trial must be implemented.

Turacoz Healthcare Solutions understands and abides by the GCP. We aim to deliver the best of the information about clinical research. Turacoz is a medical communications company, which offers services to healthcare professionals in clinical research, regulatory writing, publication writing, medico-marketing writing, and support for conducting medical advisory board meetings.

If you have any queries, email us at [email protected].

References

  1. World Health Organization. Handbook for Good Clinical Research Practice (GCP), 2002. Available at https://www.fda.gov/files/medical%20devices/published/Presentation–Good-Clinical-Practice-101–An-Introduction-%28PDF-Version%29.pdf. As accessed Apr 14, 2020.
  2. Vijayananthan A, Nawawi O. The importance of Good Clinical Practice guidelines and its role in clinical trials. Biomed Imaging Interv J. 2008;4(1):e5.
  3. S. Food and Drug Administration. Good Clinical Practice 101: An Introduction. Available at https://www.fda.gov/files/medical%20devices/published/Presentation–Good-Clinical-Practice-101–An-Introduction-%28PDF-Version%29.pdf. As accessed Apr 14, 2020.
  4. Permissible Medical Experiments. Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10: Nuremberg October 1946–April 1949. Washington: U.S. Government Printing Office (n.d.), 2,181-182.
  5. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (1979).
  6. International Organization for Standardization. ISO 14155:2011: Clinical investigation of medical devices for human subjects — Good clinical practice (2011). Available at https://www.iso.org/standard/45557.html.As accessed Apr 14, 2020.
  7. S. Food and Drug Administration: FDA Regulations Relating to Good Clinical Practice and Clinical Trials (2015). Available at https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/fda-regulations-relating-good-clinical-practice-and-clinical-trials.As accessed Apr 14, 2020.

[/et_pb_text][/et_pb_column][/et_pb_row][/et_pb_section]

Significance of Publication Planning

Publication Writing, , , ,

Publication planning is that part of the pharmaceutical landscape that ensures that data from pharma companies (clinical trials, commentaries on drug/device class, and other publications supporting the efficacy of drug/device) is disseminated through medical journal articles–an important aspect of pharma companies’ overall marketing strategy. To publish a mix of editorials, primary and secondary publication, and review papers is the goal of efficient publication planning. Strategic publication planning can maximize product visibility throughout its life cycle. The launch of new drug/device in the market can be successful if the key clinical messages reach the target audience at the right time, for which publication planning is essential. The most successful drugs launched in the last 10-15 years have ridden on the back of a very well-implemented publication strategies. Overall, publication planning aids in the accurate reporting of scientific research, thereby promoting ethical transparency at every stage of medical research through the involvement of investigators, journal editors, and publication professionals.

An effective publication planning team is the key to an efficient publication plan. It is the publication planning team that creates a proactive plan to deliver client‑focused solutions and enable strategic planning and timely implementation of the publication plan. The first step in a publication plan is a “GAP analysis”, which can identify gaps in the literature. Thereafter, the team does an analysis of strengths, weaknesses, opportunities, and threats (SWOT) comprising product strengths, weaknesses, market opportunities, and market threats to understand which areas need maximum focus during implementation of the publication plan. For example, if the product in question has more safety issues compared to its competitors, then the publications would mostly be aimed to showcase that the safety concerns are unfounded. The publication planning team also analyzes the Health Economics and Outcomes Research (HEOR) related to the product and various competitors available in the market. In addition, it is the responsibility of the publication planning team to discuss issues related to authorship and data interpretation, and to ensure all the professionals involved in the publication process meet scientific and ethical standards. A good publication planner gets the best key opinion leaders (KOLs), study investigators, and a publication agency (if needed) to write the papers. This allows authors to concentrate only on scientific discussion, and not on logistical issues. Moreover, it encourages transparent communication between researchers and contributors.

There are also a few ethical issues that the publication planning team needs to deal with. These are shown in Figure 1.

Figure 1: Ethical issues relating to publication planning

Apart from ethical considerations the publication strategy team should know the audience; whether they intend to reach out to primary-care physicians, specialists, allied health specialists, managed care specialists, hospital pharmacists, retail pharmacists, formulary managers, and calibrate their publication plan accordingly. Based on this, they should select the journals for publication. Although publishing in a top-tier journals is prestigious, and adds substantially to a product’s first impression, it should be balanced against the length of time to publication. Prestige cannot make up for a publication that arrives too late. Early publication planning helps to ensure both goals are achieved. Finally, ensuring that a publication coincides with important meetings is an important part of efficient publication planning. This can ensure that the medical representatives at these scientific meetings have evidence to back their claims regarding the drugs/devices they are promoting.

With new guidelines such as GPP3 in place, there is an increased scrutiny on publication planning. Therefore, understanding good publication practices for providing structure and ethical implementation of the publication plan are important.

Turacoz Healthcare Solutions (THS), a medical communication company, offers services to healthcare professionals in clinical research, regulatory writing, medico marketing writing, publication writing and support for conducting medical advisory board meetings. Turacoz understands the importance of a good publication which is in line with the new GPP3 guidelines. We follow the same updated guidelines for all our publications and comply with all legal, ethical and regulatory requirements. To know more about our specialization, please do visit our services section.

World Rabies Day: September 28th, 2018

Awareness Day/Month, , , , , , ,

Rabies, a viral disease that is mainly transmitted by an infected animal bite, is a 100% preventable disease. However, it is still major a public health problem with one death reported every 15 minutes worldwide. Therefore, to raise awareness regarding the burden of rabies, and to unite efforts for its prevention and control, 28th September is celebrated globally as World Rabies Day. This day also marks the anniversary of Louis Pasteur’s death, the French chemist and microbiologist, who developed the first rabies vaccine. Celebrating the World Rabies Day serves a reminder that our fight against this deadly disease is far from over.

The first World Rabies Day was observed in 2007, which was a collaboration between the Global Alliance for Rabies Control and the Centers for Disease Control and Prevention, Atlanta, USA, with the co-sponsorship of the World Health Organization (WHO), the World Organization for Animal Health (OIE) and the Pan American Health Organization. It proved to be an extremely successful campaign, and by 2009, nearly 100 million people worldwide had been educated about rabies and ~3 million dogs had been vaccinated (as estimated by the Global Alliance for Rabies Control). On the last World Rabies Day in 2017, several major health organizations, including WHO, OIE, and the Food and Agriculture Organization of the United Nations (FAO), pledged to eliminate human deaths from dog-transmitted rabies by 2030.

The World Rabies Day has been identified as an important tool that can assist in rabies prevention by educating and mobilizing at-risk communities, animal health workers, public health practitioners, governments, key opinion leaders, and experts. Today, we have safe and efficacious animal and human vaccines that can eliminate human deaths from rabies; however, lack of awareness is the major roadblock in successfully engaging communities for rabies prevention. Rabies prevention and control has two broad components: animal rabies control and human rabies prevention. Pictorial description of both are shown in Figure 1.

 

 

Figure 1          Rabies prevention and control

The World Rabies Day campaign has a centralized online platform where groups can register their World Rabies Day events and download resources, in print and online, that can support their message for rabies prevention. Moreover, since rabies is a disease that can easily cross borders, especially in wild animal populations, the campaign encourages trans‑national collaboration of rabies control and prevention. The World Rabies Day logo represents the complexity of rabies, which can infect human beings, wildlife and domestic animals, and therefore, needs an interdisciplinary approach to control it.

Overall, the World Rabies Day is a campaign for education, awareness, and action to encourage organizations across all levels-international and local-to increase the spread of messages for rabies prevention. With this blog, Turacoz Healthcare Solutions (a medical communication company) aim to raise awareness about rabies prevention and highlight progress in defeating this animal transmitted viral disease.

Borderline Medical Devices – European Commission Update (December 2017)

Medical Devices, , ,

When a device seems to fit onto the definitions of two or more product types, and cannot be clearly classified as a medical device, an in vitro diagnostic medical device, or an active implantable medical device, it is referred to as a borderline medical device. The 18th version of the Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices (Borderline Manual) was issued by the European Commission’s Medical Devices Expert Group (MDEG) on Borderline and Classification in December 2017. The manual complements MEDDEV 2.1/3 Rev. 3, which provides guidance on borderline products and other medical devices that incorporate pharmacological or biological substances. The appropriate classification of a medical device is important as it determines the device’s authorization process and marketing strategy. From a regulatory standpoint, the classification is usually based on its primary mode of action, intended use, and product claims.

The updated Borderline Manual includes recommendations on a total of 94 devices, including guidance on the classification of 12 additional product types; however, these recommendations are not legally binding. It is important to note that the decisions on the classification of a product remain a competence of the Member States, which may lead to different interpretations among different countries within the EU. However, to ensure a uniform approach, difficult cases may be discussed in the informal MDEG; the consensus statements from this meeting are published in the Borderline Manual.

The revised Borderline Manual indicates that the following products should generally be classified as medical devices:

  • Mobile application for the assessment of moles (Class I)
  • Liquid nitrogen for cryopreservation of cells and tissues of human origin for medical purpose (Class IIa)
  • Alum styptic pencils (Class IIa)
  • Dura guard for use with a craniotome (Class III)
  • Heart bypass cannulae (Class III)
  • Tissue expanders used in the breast (Class III)

On the contrary, the following products should, in principle, not be considered as medical devices:

  • Mobile application for managing pictures of moles
  • D-mannose for the prevention of urinary tract infections
  • 8-MOP solution in extracorporeal photochemotherapy
  • Products intended to reduce the effect of alcohol
  • Radiation shields
  • Microplate washers

It is important to note that based on criteria proposed by the Court of Justice of the European Union (CJEU) for borderline determinations, each product’s assessment should include several elements and be very factual; however, the guidance provided in the Borderline Manual often lacks such a detailed and balanced review. Moreover, some of the positions taken in the Borderline Manual may require reconsideration due to potential reclassifications brought by new European Commission Regulations. The new Regulations broaden the definition of a medical devices and also include some products without medical purpose within the purview of the new rules (especially products for aesthetic use). Although changes introduced by the new regulations may help resolve some of the existing borderline questions, divergent views on the classification of more complex products may persist.

Turacoz Healthcare Solutions, a medical communication company, specializes in various kinds of medical writing documents (Publication, Regulatory and Medico marketing) which covers a vast arena of clinical trials, drugs, medical devices, health economics and outcome research, observational studies etc.  We take pride in providing customized, guideline compliant documents which are well within the committed timelines.

Writing an Original Research Article

Medical Writing, , , ,

What is an Original Research Article?
Original research articles, the primary sources of scientific literature, are considered to have the highest level of evidence/quality of evidence. An article is considered an original research if;

  • It is an article by the researchers who have conducted the study
  • It is a report that elaborates the methodology and results of a randomized controlled trial/observational study/survey/real world evidence study
  • It is an article that describes a hypothesis or research question

Overall, the goal of an original research is to answer the question about specific scientific method, compare two treatments (experimental vs comparative), or establish a hypothesis.

How to Plan a Manuscript?
Conception of a manuscript to submission, has several steps in between. Before we discuss the content that must go in each section, let us read through the steps that must be followed to plan, draft, and complete a manuscript draft as illustrated in Figure 1.
Among the steps involved in drafting a manuscript, understanding the therapeutic area and conducting a literature search appropriately are the most important steps. Literature search is usually done based on the research question of the study. Identifying relevant articles during the literature search is dependent on picking the right search terms, electronic databases to be searched, region of the study, and time duration in which the articles are required.

Figure 1: Steps Involved in Planning and Completing a Scientific Manuscript

What is the Format to be Followed while Writing an Original Research Article?

Drafting an original research article requires adequate knowledge of the different sections in it along with the relevant guidelines. The uniform requirements for manuscripts submitted in biomedical journals by International Committee for Medical Journal Editors (ICMJE) has defined a standard format for presenting information in an original research article. As per this guideline, the IMRAD (Introduction, methods, results, and discussion) format must be followed.
IMRAD defines the overall format of the manuscript. However; the equator (Enhancing the QUAlity and Transparency Of health Research) network is an international initiative that aims to improve the reliability and value of published health research literature (http://www.equator-network.org/).

What goes Where: Know the Sections and their Content
Although IMRAD broadly defines the format of an original research article. One must be clear, and specific about the information that must be added in each section for a well written manuscript (Figure 2). This not only makes the manuscript clear to understand but also increases the chances of it getting accepted in the journal the author plans to submit it to.

Figure 2: IMRAD, Section-wise Description of a Scientific Manuscript

Turacoz Healthcare Solutions (THS), a medical communication company, offers services to healthcare professionals in clinical research, regulatory writing, medico marketing writing, publication writing and support for conducting medical advisory board meetings. The aim of the blog was to appraise its readers regarding the importance of following guidelines and their importance for writing and getting original research articles published.

Healthcare Advertising

Medical Writing, ,

“Are you into healthcare advertising?”

“Yes!”

“Oh! It involves so much medical jargon, and little opportunity for creativity! Do you enjoy your job?”

I have been part of several such conversations, and through this blog, I would like to touch upon some facets of healthcare advertising that may partly undermine (and partly reinforce!) the stereotypes associated with this field.

Based on data from a 2015 US-based study, nearly $10 billion is spent by the healthcare industry into advertising and marketing. Despite the huge amount of money involved, the healthcare advertising segment is often typecast as “lacking in creativity/innovation” and “boring”. Well, this is not surprising considering that every print, website, banner, and video advertisement gets scrutinized by a medical review team and needs to pass a rigorous risk mitigation assessment. In fact, dissemination of safety information takes up almost half of a 30 second TV spot and rules for short-form messaging may run up to 10-15 pages. With such extensive regulations in place, it is often difficult to be creative! Most advertising professionals, therefore, create campaigns that are safe and obvious to avoid getting caught in the legalities of the system.

In addition, creating advertisements from data provided by doctors, is quite challenging. The key is to understand the underlying motivation behind the drug/campaign from an emotional perspective, including purchasing decisions and consumer behavior.

Future of healthcare advertising

How can healthcare advertising evolve in the near future? Here are a few pointers:
1)  Optimizing advertisements for mobile phones (smartphones) and using social media apps, such as Facebook and Twitter, as marketing platforms
2)  Developing smart (read: social-media shareworthy) content that is interesting, fresh, reliable, and authoritative
3)  Individualizing marketing delivery systems using digital marketing tools: Contemporary marketing methods identify user interests and deliver timely, personalized and relevant content on a one-to-one basis
4) Target patients by location: Such a strategy can adapt the advertisement according to social and personal preference of the audience, and also inform them about nearby facilities
5)  Going live! “Programmatic video” is the new buzzword in the field, and according to some estimates, it will account for the majority of digital video spending over the next couple of years. Programmatic video basically uses real time data and presents video advertisements to precisely qualified customers at exactly the right time.

Overall, it can be concluded that healthcare advertising may not be as creative as the fast-moving consumer goods (FMCG) segment; however, the challenges it poses make it all the more interesting to work in this field. With the evolution of new marketing strategies, the constraints of healthcare advertising can prove to be an asset in a non-conventional marketing set-up of the future.

Turacoz Healthcare Solutions provides high quality end to end scientific/medical writing support to the industry and academia. We expertise in different kinds of medicomarketing solutions like leave behind literature (LBL), slide-decks, posters, newsletters, patient education materials, customized books/booklets, visual aids etc. Turacoz strongly follows good marketing practices backing every product claim with scientific relevance and ensuring that the message rightly resonates with the target audience.

Health Economics and Outcome Research

Publication Writing, , , , , , , , ,

Health economics and outcomes research (HEOR) activities comprise of Pharmacoeconomics (PE) research and health technology assessment (HTA) activities. Health economics (HE) is applied to analyze the economic aspects of health and healthcare, with focus on the costs and consequences of healthcare interventions.

PE, a sub-discipline of HE, provides a comparative value assessment between two pharmaceutical products or treatment mix. Outcome research (OR) helps in evaluating the effect of healthcare interventions on patient-related clinical, humanistic, and economic outcomes.

Thus, HEOR is a discipline that helps the stakeholders to fully understand the product value and its potential in real-world clinical practice. In healthcare industry, the stakeholders and payer rely on HEOR to gain market access and remain competitive. For this, pharmaceutical and medical technology manufactures provide clinical development information (i.e. efficacy, safety and quality) and economic evidences to guide decision makers regarding patient access to specific drugs and services. These evidences help in determining whether the treatment is effective in the populations they serve.

Sources of HEOR Evidence

To generate outcomes to monitor and evaluate healthcare services, we need to collect evidences from different sources which can be further used for decision-making processes. These evidences can be collected from different sources as shown in Figure 1:

Health Economics and Outcome Research 2

Figure 1: Sources of health economics and outcome research (HEOR) evidence

Need of HEOR Evidences

The HEOR evidences are helpful in identifying unmet needs and addressing evidence gaps. The real-world data can be used to determine primary randomized control trial (RCT) endpoints (e.g. laboratory test results) which is considered as the most relevant clinical outcomes for physicians and healthcare decision makers. These evidences also help in promoting the patient-centered research and helps in developing and evaluating the cost containment strategies.

Tools for HEOR

There are several approaches which can be applied to the collected evidences through which a meaningful outcome can be achieved. Below are some tools which are used to analyze data.

  • Exploratory Data Assessment
  • Epidemiology study
  • Cost-benefit Analysis (CBA)
  • Cost of Illness Analysis
  • Budget Impact Model (BIM)
  • Cost-effectiveness Analysis (CEA)
  • Satisfaction Assessment
  • HRQL Analysis
  • Assessment of Analysis Compliance and Persistence
  • Market Assessment
  • Pricing Strategy

Types of Outcomes

Generally, the outcomes are of three types namely, clinical outcomes, economic outcomes and humanistic outcomes.

Health Economics and Outcome Research-2Today there is increased emphasis on HEOR activities due to the growing power of payers in the healthcare decision-making. This has led to HEOR professionals covering all aspects of drug development to ensure they have the right data and analysis. This growing importance of HEOR is reflected in the phenomenal increase in the field-based HEOR professionals employed by the pharma companies.

Turacoz Healthcare Solution (THS) aim to deliver the best quality and guideline compliant documents to the pharma and different sectors of healthcare industry. We are dedicated in providing scientific/medical writing support to the industry and academia. With expertise in several clinical trial related documents like Investigator Brochures (IBs), Protocols, Clinical Study Reports (CSRs) Prescribing Information (PI), and Common Technical Documents (CTDs). We also provide services for health economics and outcome research.

Transparency in Scholarly Publishing

Publication Writing, , , , , , ,

A research publication is considered as the highest-level medium of dissemination of research findings. Scholarly publications play an important role in disseminating findings, thoughts, and analysis to the scientific, academic, and lay communities. Transparency is an ethic that strengthens the credibility and integrity of research work as well as bonding among the scholarly communities. Due to frequent questioning on research credibility, pressure for open access by governments, and high incidences of research frauds, it has become important to form and follow the principles of transparency.

Principles of Transparency

The Committee on Publication Ethics (COPE), the Directory of Open Access Journals (DOAJ), the Open Access Scholarly Publishers Association (OASPA), and the World Association of Medical Editors (WAME) together have structured the principles of transparency, discuss all aspects of publication ethics and formulate the best practices to overcome any issue in this regard. The various principles of transparency and best practice in scholarly publishing are described as under:

These principle also help in differentiating the legitimate journals and publishers from the non-legitimate ones.

As per transparency, the scholars should give an access to the research data and methods employed for deriving the conclusion. The data production methods should be shared in a much wider platform. If scholar’s research is based on another researcher’s data, he or she should always cite their data clearly. The rules of data confidentiality, wherever applicable should be followed ethically.

Both the perspectives of transparency, viz. transparency in policy context and transparency in research process should be followed to make the scholarly publishing stronger and more reliable.

Publication plan carrying complete information about all types of publications or articles to be formed from the research or clinical studies also contributes towards ethical practice. A proper and firm publication planning can help researchers follow appropriate publishing practices, in time publication of research and hence, increased transparency.

Turacoz Healthcare Solutions (THS) provides end-to-end medical publication writing support including scholarly or academic publication, research publication, manuscripts, slide deck as well as regulatory writing support for clinical trials which includes Prescribing Information (PI), Investigator Brochures (IBs), Protocols, Clinical Study Reports (CSRs), Clinical Evaluation Reposts (CERs) and Common Technical Documents (CTDs). Our documents are guideline compliant and are as per the current pharma and the healthcare standards. We aim to extend our services to different domains of the industry around the globe.

World Malaria Day (25th April 2018)

Awareness Day/Month, , , , , ,

“Ready to Beat Malaria”

World Malaria Day has become a global phenomenon and is celebrated on 25th April every year since its inception in 2007. This year’s global theme for World Malaria Day is ─ “Ready to Beat Malaria”. This theme encloses the universal goal of developing a malaria-free world. Further, it emphasizes the progress achieved in the past to tackle one of humanity’s oldest diseases; and at the same time grabs our attention towards the escalating trends reported in the 2017 World Malaria Report. After a remarkable period of success in controlling the spread of malarial cases, the progress appears to have slowed down. Hence, this year, World Health Organization (WHO) demands a greater expansion and investment of recognized tools that can prevent, diagnose, and treat malaria.

Malaria is an infectious disease caused by Plasmodium parasites that are transmitted to people through bite of infected female Anopheles mosquitoes (malaria vector). Initial symptoms include mild fever, headache, and chills, which might become lethal if left untreated for more than 24 hours. Severe malaria often leads to development of cerebral malaria or severe anaemia or involvement of multiple organs.

Statistical Facts according to the 2017 World Malaria Report:

  • In 2016, 216 million cases of malaria were estimated in 91 countries, corresponding to a surge of 5 million cases over those reported in 2015.
  • A total of 445,000 fatality cases were reported in 2016 compared to 446,000 in 2015.
  • In 2016, African regions shared a high global malaria burden, with 90% of malaria cases and 91% of mortality cases.
  • In 2016, India reported 6% of the world’s new malaria cases.

Prevention:

Transmission of malaria can be prevented and reduced with effective vector control. Vector control can be achieved in the following ways:

  • Insecticide-treated mosquito nets: WHO recommends the use of long-lasting insecticidal nets (LLINs) for people residing in areas at high risk of malaria. Pyrethroids are the only class of insecticides presently recommended for use in LLINs.
  • Indoor residual spraying with insecticides: This is a powerful method for rapid reduction of malaria transmission. The effect of indoor spraying persists for 3-6 months, depending on formulation of the insecticide used.
  • Antimalarial drugs: The travelers can use chemoprophylaxis as an effective method for prevention of malaria, as it suppresses the blood stage of malarial infections. WHO recommends the use of sulfadoxine-pyrimethamine for pregnant women at risk, and monthly courses of amodiaquine in addition to sulfadoxine-pyrimethamine for children at risk below 5 years during high transmission season.
  • Vaccines: Partial protection in children can be achieved by administration of an injectable vaccine “Mosquirix”. The vaccine is a complementary malaria tool rather than a replacement for treatment strategies.

Diagnosis and Treatment:

The diagnosis and treatment of malaria at an early stage limits transmission of the disease, reduces the risk of complications, and prevents death. Parasite-based diagnostic testing (either microscopy or rapid diagnostic test) is suggested by WHO prior to administering the treatment. Post-parasitological confirmation, artemisinin-based combination therapy (ACT) is used for treatment of Plasmodium falciparum malaria.

Turacoz Healthcare Solutions aims to spread awareness about malaria and strategies for its prevention, to aid ‘World Health Assembly’ achieve the global target of reducing 90% of incidence and mortality rates by 2030. Turacoz is a medical communications agency, which offers services to healthcare professionals in clinical research and regulatory writing, publication writing, medico-marketing writing, and support for conducting medical advisory board meetings.