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EDG: Writing Clinical Study Reports for Studies with Complex Protocols
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Description
Clinical studies are increasingly complex. Although Phase 1 studies usually have simple designs, time, cost, and ethical pressures have led to clinical researchers designing studies with options for change according to results as they arise. The modified-Fibonacci dose-escalation design for chemotherapy studies was among the first adaptive designs. More recently, complex statistics are applied to enable decision making during ongoing studies. Umbrella, basket and platform studies are a few examples of clinical study designs from which medical writers are called upon to write a clear, comprehensive, and coherent clinical study report (CSR), or several CSRs, or one CSR with several parts … or another approach.
The purpose of this EDG is to share experience and ideas on the best way(s) of approaching writing CSRs for studies with complex designs.