Essential knowledge areas for good protocol writing
Medical writing has always been my passion. After all these years of experience, when I reflect back, I always feel gratitude towards almighty for giving me all those experiences across all my job functions to become well versed with medical writing. Across various types medical and scientific writing tasks, protocol writing is the most important task in clinical research. Any research starts with protocol and ends with clinical study report/manuscript.
It is easy to write a protocol, but it is very difficult to write a good protocol, which fits the purpose – scientifically robust, easy to execute and results in meaningful conclusion. These are my takes on knowledge areas of good protocol writing:
Understanding of research question :
It is very important to understand objective of the study. What is the purpose to conduct a particular study? What outcomes are desired from this study? Interaction and brainstorming with project director and project team helps a lot. Don’t shy away from asking questions to your seniors. This is the biggest mistake most the novice writers do.
Gain the scientific knowledge:
Extensively read about drug of interest and indication to be pursued. Do thorough literature search for endpoint selection, study design and study population. Literature search for protocol development is the art which can be mastered with practice and combinations of different MESH terms. Use databases like PUBMED, Scopus, Sciencedirect etc. at abundance.
Research regulatory requirements:
Decide, whether the study is regulated research or non-regulated research. Try to gather information about regulatory submission destination and study conduct geography. This will help in understanding regulatory requirements and built them in protocol. Regulatory compliance is a major determining factor in acceptance of the study. Global the study, more detailing is required. Clinical practice varies in different countries for the same indication, and it is important to balance practice with research for optimum patient enrollment.
Understand operational challenges:
A protocol can only be execution friendly if operational factors are kept in mind. An experience as a site coordinator and clinical research associate can help a lot. In fact, as per my view, to prepare operationally easy protocol is not possible if you don’t have basic knowledge of site operations dynamics. This experience helps in decreasing protocol deviations at a large and improving protocol compliance at site level.
Identify stakeholders:
Prepare a synopsis and share for review to various stakeholders. Stakeholders related to protocol preparation are medical monitors, statisticians, data management teams, laboratory personals, clinical operation teams, quality assurance team, product manufacturing team, safety team, pharmacokinetic teams and other applicable stake holders. External review from few Key Opinion Leaders (KOLs) can also add tremendous value to protocol. Carefully reviewed and discussed protocol produces magical results.
Know your standard operating procedures and template:
Go through your SOPs and templates and choose the wise one. Make sure that protocol template you select is compliant with regulatory requirements.
Don’t forget to do self Quality Check:
Re-read your own written document. Use Grammar and Spell check function of Microsoft word intelligently. Look for copyrights of resources used in protocol and refrain from plagiarism. Quality protocol require quality oriented mindset. Don’t compromise with quality at the expense of time. Discrepancies leads to more rework and waste of time.