This time, the phase 3 study was a pivotal trial of approximately 350 patients with analyses on half a dozen efficacy endpoints and a dozen safety endpoints. The report contained 50 in-text tables, 10 figures, and over 100 post-text tables and figures (Section 14).
In the end the impossible was done: The first draft was written in 4 working days and the final version was ready for sign-off in 3 weeks, including editing and QC. (Another writer wrote the text Section 12 Safety, which shaved a day off. Without the assistance I would need 5 working days for the entire draft.) Besides the large-scale coordination and collaboration among all the departments involved, I learned a few lessons specific to writing:
1. Preparation. Do as much as possible before the clock starts ticking. Finalize the "shell" by working with the team. Work with biostatisticians and data programmers to review and understand all the tables and figures. Get the appendices lined up. Establish an internal style guide.
2. Immersion. The fastest way of writing a study report is to hold in your brain as much information about the study as possible before and during the writing. If you don't need to look up the definition and assessment method of every endpoint, you can carry on describing the data accurately and correctly without a pause and achieve the "flow" that makes the work enjoyable.
3. Brevity. To write concisely is generally desirable but especially critical in a shortened timeline. Do not repeat every data point in the in-text tables. The text is used to draw attention to key efficacy and safety results. Focus on the data that support the endpoints.
4. Communication. If you need help, ask. Do not wait. The medical monitor and statistician are your most valuable resources to help you make sense of the data. They can help you resolve data anomalies and clarify ambiguity. Report your progress often, so that the team is aware of any risk to the deadline and can lend you a hand if necessary.