Introduction

This chapter illustrates via retrospective analyses of a longitudinal clinical trial how the principles and recommendations outlined in previous chapters can be applied a priori, such as would be required in regulatory settings for confirmatory trials and for optimum decision making in early phase trials. The next section describes the setting, the data, and the originally reported results from the trial used in the present re-analysis. Section 14.3 specifies the objectives and Section 14.4 describes the analysis plan for the retrospective analyses as they could be prespecified, using ideas presented in Chapter 12. The results from the retrospective analyses are presented in Section 14.5, followed by a discussion on how principled inferences can be drawn from the results.

Having proper tools to conduct sensitivity analyses is essential if they are to be a routine part of clinical trial analysis and reporting. Software tools to implement the various analyses presented in this chapter are made available in Chapter 15.