Ever since the holy trinity important things have come in threes—listen up. Study section will not (and should not) cut you slack.

1.) No matter how many clinical trials you have completed, don’t count on your coattails.

We need all the details:  Recruitment, enrollment, randomization, comparison condition, data an specimen collection, estimated retention and cross-over, analytic plan including power for sub-analyses, adverse event definitions, and how your DSMB will work. Best case: have your IRB done and protocol posted.

2) And there is a double standard.

Behavioral and systems-level interventions must clear a higher bar. Clustering, cross-contamination, attention control, and risks must be addressed. You cannot claim your trial has no risks.

3.) Ignore sex and gender and get triaged.

A throwaway sentence about the challenges of including women won’t fly anymore. Don’t go there.

Trialists can get caught up in Good Clinical Practice jargon, boilerplate language, and referencing prior publications. Failing to bring the logistics and operational details of the proposed trial to life will hurt your grant score…and only nearly perfect scores clear the payline.

Need more crankiness:

 

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