摘要: A carefully conceived and written protocol document is essential for the conduct of the phase I trial. The rationale for the study, background drug information, population to be included, selection of starting dose, how escalation will proceed, and the endpoints that will be employed are all vital elements. Furthermore, description of how data will be analyzed and decisions made regarding dose escalation and phase II dose recommendations must be included. This chapter will detail and offer examples of all these basic protocol elements for a phase I first-inhuman trial. Where relevant, comments on how these elements should be modified for combination phase I trials will be included.