Continuing her interview series, Dr. Nimita Limaye further answers questions from our guest audience members surrounding medical writing practices for clinical study protocols. She focuses on the role a medical writer plays in the process of writing these strategic documents.

Jane: Hi Dr. Limaye, why is the clinical study protocol considered to be such a strategic document?

Dr. Limaye: Jane, a clinical study protocol is considered to be a strategic document, since it provides not only the study rationale, but it also serves as the blueprint for the conduct of the trial. A well written protocol can set the stage for a successful trial and plays a key role both in terms of strategy and execution.

Jane: Do protocols get amended frequently?

Dr. Limaye: Yes, you are right, the frequency of protocol amendments is very high. Tufts CSDD had reported that about 40% of protocols are amended even before the first subject receives the first dose, and in phase I studies more that 50% of amendments occur before the first patient has been enrolled. It has highlighted that the average cost of one amendment is $500, 000 and an amendment adds up to 61 days to the protocol timeline.  These delays can prove immensely expensive to a pharmaceutical company. Every day’s delay in bringing the drug to market can cost a company $8 million.

Jane: So why are there so many protocol amendments?

Dr. Limaye: The number of protocol amendments has increased because the complexity of protocols has increased over the years. This includes the number of end points, the complexity of the study design, the number of sites etc. While many of the amendments result from new safety information, new regulatory requests, changes in the standard of care or study objectives, nearly one-fourth of protocol amendments are considered to be completely avoidable.

Jane: So what role does the medical writer play in this process?

Dr. Limaye: The medical writer plays a strategic role in authoring this document. The writer should be included in the protocol strategy meeting and should work with the key stakeholders such as the clinical project manager, clinical scientists, medical monitors, data managers, biostatisticians, regulatory affairs and even investigators to help develop a protocol synopsis. The protocol synopsis should clearly outline the research question, the target population, the study hypothesis, the study design, clear objectives and well defined primary and secondary endpoints. This document shall set the stage for the protocol development process. While there is enormous pressure to get that protocol approved, a rushed job will only result in multiple amendments and expensive delays.

Jane: What are the important skills that a medical writer requires for authoring study protocols?

Dr. Limaye: Well, it is important that the medical writer needs to recognize that the audience for the study protocol may include regulators, the principal investigator and his team and IRBs. Hence, the writer needs to structure the document in a manner that the needs of each stakeholder are appropriately addressed. The medical writer also requires excellent negotiation skills and the ability to drive alignment between multiple stakeholders. The ability to patiently create multiple drafts of the protocol and sometimes, even circle back to the original one, is a skill to be admired, Other skills include co-authoring skills, as well as the ability to present the study rationale in a manner that is objective and scientific, yet building both confidence and interest in the trial. An eye for detail and a high focus on quality, need to be complemented by strong project management skills.

About CSOFT Health Sciences

CSOFT Health Sciences provides end-to-end medical translations for all phases of the product lifecycle, from pre-clinical to post-launch. We also specialize in market access consulting, medical writing, and CTD/eCTD submissions with the FDA, EMA, and NMPA. Our operations are compliant with ISO 17100 and certified in ISO 9001:2015 and ISO 13485:2016, ensuring our customized solutions meet the rigorous regulatory requirements of global submissions.


CSOFT International is a leading provider of cross-border communications for enterprises seeking growth in global markets. Our expertise in localization, documentation, and branding encompasses a full range of end-to-end content and consulting services that we deliver in over 250 languages. With a focus in health sciences and smart technology, we work closely with our clients to deliver precision solutions to the challenges of engaging markets, consumers, and regulatory environments worldwide.