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International Journal of Recent Innovations in Medicine and Clinical Research 2024;6(2):53–55
Content available at: https://www.ipinnovative.com/open-access-journals
International Journal of Recent Innovations in Medicine and
Clinical Research
Journal homepage: https://www.ijrimcr.com/
Short Communication
The role of medical writing in clinical research
Abhijit Trailokya1*
1Dept. of Medical Affairs, Indoco Remedies Limited, Mumbai, Maharashtra, India
ARTICLE INFO
Article history:
Received 20-06-2024
Accepted 12-07-2024
Available online 08-08-2024
Keywords:
Medical writing
Clinical research
ICH GCP
Protocol
ABSTRACT
Medical writing is a specialized field that involves the creation of scientific documents by writers with a
detailed understanding of medical and scientific concepts. In the past few decades, medical writing has
seen substantial growth in India. This field encompasses the creation of regulatory documents, safety
reports, publications, and educational and communication materials pertaining to health and healthcare
products. These documents are crucial in various aspects of healthcare, including clinical research,
regulatory affairs, marketing, and education. Medical writing plays a crucial role in the successful execution
and documentation of clinical trials. This article delves into the responsibilities of medical writers, the
importance of their work in the clinical trial process, and how they ensure regulatory compliance and clear
communication of clinical trial outcomes.
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1. Introduction
Medical writing in clinical research is a specialized field
that involves creating well-structured and scientifically
accurate documents related to clinical research as per
the requirement of regulatory authorities (DCGI, USFDA,
etc.).1These documents are essential for the regulatory
approval of new drugs, biologics, and medical devices, as
well as for the dissemination of clinical trial results to the
scientific community.2,3 Medical writers need to combine
their scientific knowledge and their research understanding
as well as detailed knowledge of GCP and ICH guidelines
to present information at the right level for the target
audience.2Medical writing ranks as the fourth most
frequently outsourced activity in clinical development. Its
global demand has consistently risen, driven by increasing
cost pressures within the pharmaceutical industry.1
* Corresponding author.
E-mail address:abhijit.trailokya@indoco.com (A. Trailokya).
2. Writing for Clinical Trial Documents
Medical writers are critical to the communication process
of outlining the goals, strategies, analysis, and medical
understanding of a clinical trial/program to patients, sites,
sponsors, and regulatory agencies.
Medical writers are involved in writing for various
Clinical research documents highlighted in Figure 1.
3. Responsibilities of Medical Writers in Clinical Trials
Responsibility starts from designing a synopsis and ends
with the publication of trial results or manuscripts in a
reputed journal.
3.1. Synopsis/protocol development
Medical writers were involved in developing a clinical
trial synopsis followed by protocols that outline the study
objectives, design, methodology, statistical considerations,
and operational aspects of the clinical trial in consultation
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54 Trailokya / International Journal of Recent Innovations in Medicine and Clinical Research 2024;6(2):53–55
Figure 1: Various documents related to clinical research
with therapy experts from the respective fields. A well-
written protocol ensures that all investigators follow a
standardized procedure, which is critical for the integrity
of the trial data. Medical writers should have adequate
knowledge and experience not only in clinical trials but also
in the regulations involved in clinical research. He has to
work in collaboration with therapy experts, investigators,
regulatory experts, etc.
3.2. Informed consent documents
They create informed consent documents to ensure
participants understand the study’s purpose, procedures,
risks, and benefits. Clear and comprehensive informed
consent forms help protect participants’ rights and ensure
ethical standards are upheld.
3.3. Clinical study reports (CSRs)
A CSR is a critical document for regulatory submissions and
must present data in a clear, logical, and unbiased manner.
Medical writers prepare CSRs that provide a detailed
account of the trial’s methodology, results, and conclusions
in collaboration with investigator, subject expert, statistician
etc.
3.4. Regulatory submissions
Accurate and complete submissions are essential for
obtaining regulatory approval to market a new drug. They
compile regulatory submission documents, including
Investigational New Drug (IND) applications, New Drug
Applications (NDAs), and Marketing Authorization
Applications (MAAs).
3.5. Manuscripts and publications
Medical writers draft manuscripts in consultation with the
principal investigator, statistician, etc., for publication in
peer-reviewed journals to disseminate trial findings to the
broader scientific community.
Figure 2: Importance of medical writing in clinical trials
3.5.1. Requirements for becoming medical writer for
clinical research
The basic prerequisite for becoming a medical writer is
familiarity with medical concepts and terminology. An
academic qualification in one of the life sciences branches
like medicine, or paramedical sciences such as pharmacy,
science graduates and postgraduates, doctorates (PhD) in
science background can provide the right background which
makes the writer familiar with scientific concepts and
research data. Some degree of command over the language,
reflected by an ability to write grammatically correct text
and an ability to express and present information clearly and
succinctly, is most important. In addition to the above basic
requirements, one needs domain knowledge and language
skills, including: 1) Medical and therapeutic area knowledge
2) Drug development process, pharmacology, drug safety
3) Basic understanding of statistics 4) Technical guidelines
in relation to clinical research and regulatory affairs 5)
Interpretation and presentation of research data.
4. The Demand for Medical Writing in Clinical
Research
The demand for medical writing has gone up considerably
in the last few years. The reasons are many – more research
studies are being conducted today in the biomedical field,
pharmaceutical companies are developing more new drugs
and medical devices, and various scientific documents
need to be generated for submission to regulatory
authorities during their approval process. India offers
unique advantages for outsourcing medical writing services,
including a large workforce of science graduates and
medical professionals proficient in English, coupled with
lower operational costs.1,4,5
Many leading pharmaceutical companies, including
multinationals, maintain in-house medical writing teams.
Several have established captive medical writing teams
in India to leverage the expertise of local medical
writers and address the needs of the expanding clinical
Trailokya / International Journal of Recent Innovations in Medicine and Clinical Research 2024;6(2):53–55 55
trials market in the country. India has steadily attracted
medical writing business from pharmaceutical companies
worldwide, particularly from those in the US and UK. Most
of the top 20 global pharmaceutical companies outsource
their medical writing work to India.4
5. Conclusion
Medical writing is a vital component of the clinical
research process, ensuring that all documentation is clear,
accurate, and compliant with regulatory standards. By
translating complex scientific data into understandable
formats, medical writers play a key role in advancing
medical research and facilitating the development of new
treatments.
6. Source of Funding
None.
7. Conflict of Interest
None.
8. Acknowledgment
Thanks to Mr. Santosh Tompe (Senior Manager Clinical
and Regulatory Affairs, Indoco Remedies Ltd., Mumbai) for
helping with manuscript writing.
References
1. Sharma S. Development of medical writing in India: Past, present and
future. Perspect Clin Res. 2017;8(1):45–50.
2. Korieth K. Demand for medical writing continues to rise. Centerwatch
Mon. 2008;15(12):8–13.
3. Sharma S. How to become a competent medical writer? Perspect Clin
Res. 2010;1(1):33–7.
4. Shirke S. Medical writing on an accelerated path in India. Perspect Clin
Res. 2015;6(3):125–8.
5. Kanade M. Medical writing; 2022. Available from: https://www.
companysconnects.com/post/medical-writing.
Author biography
Abhijit Trailokya, Head Medical Affairs
Cite this article: Trailokya A. The role of medical writing in clinical
research. Int J Recent Innov Med Clin Res 2024;6(2):53-55.