ABSTRACT
Recalling the process chart for study development introduced in Chapter 2, development of analysis plans begins with considering the objectives of the trial, which are determined from the decisions to be made from the trial. Estimands are chosen to address the objectives. A design is chosen to focus on the primary objective, and to also address key secondary objectives to the degree feasible. With clarity on objectives, estimands and design, analyses and sensitivity analyses can be chosen. It is important to appreciate the benefits from this being an iterative process, essentially then jointly considering all aspects of the process. Iteration can lead to objectives, estimands, and designs that are more relevant given the circumstances, and analyses that are aligned with the design, estimands, and objectives.
