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Lost in translation ‐ challenges for academic scientists in writing clinical protocols

Writing clinical protocols is often challenging for early‐career scientists because it requires knowledge and perspectives uncommonly taught during academic training. This presentation from an academic scientist, IRB reviewer, and regulatory professional will focus on challenges in translating a NIH grant proposal into a Phase I/II clinical drug protocol. Numerous required elements in a clinical protocol are not emphasized in grant proposals; these elements will be compared and contrasted. Elements commonly deficient in clinical protocols include: detailed knowledge of FDA‐approved drug labels including risks and indications; inclusion/exclusion criteria that enable timely recruitment while limiting confounders; distinction of primary versus secondary outcomes and statistical power for the primary endpoint; inclusion of primary and secondary safety endpoints; and inclusion of a detailed trial monitoring plan and risk mitigation approaches. In addition, several logistical realities of clinical studies are novel to basic scientists, and these elements affect clinical trial design and execution. In translational research settings, formal training in writing clinical protocols is desirable for junior faculty to facilitate regulatory review and study execution. The author is supported by National Institutes of Health grant number UL1TR000433.