|
Abstract:
|
An independent data monitoring committee (IDMC) is charged to review the ongoing safety of trial participants and the scientific validity and merit of the trial and to make recommendations to the sponsor whether the trial should continue as planned, modify, or terminate because of safety, futility, or efficacy. Because a statistical analysis plan (SAP) serves as a benchmark for the final report, it needs to be explicit about the contents and format. An interim analysis plan, however, serves as a benchmark for the ongoing review of the safety and efficacy by the IDMC and cannot be codified as in SAP. Instead, it needs to be flexible to address any concerns emerging during the trial and to evolve with the trial. A dialogue will be held among statisticians representing sponsor, independent statistical center, and IDMC to improve the contents and format of the interim reports.
|
