The Statistician's Role in Developing a Protocol for a Clinical Trial

As a member of a clinical investigative team developing a protocol for a clinical trial, the statistician has broad responsibilities for ensuring the scientific integrity of the product.To prepare for this role, the statistician must study and learn in detail the clinical subject matter and must be prepared, if necessary, to teach the statistical principles of clinical trials to collaborators.This article discusses various issues that arise in the design of a clinical trial and how the statistician can participate in their resolution.