ABSTRACT
A protocol has to be developed for each clinical trial. A most important responsibility of the statistician or biostatistician assigned to the protocol is to provide its statistical content. This includes ensuring that the objectives are clear; recommending the most appropriate design (experimental design and determination of sample size) for the condition being studied; assessing the adequacy of endpoints to address study objectives; assigning participants to protocol interventions to minimize bias; and developing the statistical analysis section. In addition, it is imperative that the biostatistician provides a review of the protocol for completeness and consistency. Sections 6.1 through 6.5 provide a simple outline for a protocol. Biostatis-
tical input to these sections is discussed.
