Closeout and Reporting
We have seen that before enrollment in a trial begins, the protocol, which establishes all trial procedures, outcome measures, and analyses, must be in place. A similar set of procedures must be established to bring the trial project to a close once subject follow-up is complete. There are multiple tasks to be completed at the clinics, by the sponsor and study leadership, and by the statistical or data coordinating center. The literature on these topics is extensive and we will consider only some of the major issues that have important statistical implications. First, we will discuss important issues in the closeout of a clinical trial. We will emphasize those challenges commonly encountered by the statistical center. We will then focus on reporting issues. There are at least three types of reporting activities: presentation of results at professional meetings, publication of results in scholarly journals, and regulatory reporting for product approval. Of these, we will focus on the publication and presentation aspects. Regulatory aspects were briefly discussed in Chapter 1.
12.1 Closing Out a Trial