Early viewing of noninferiority trials in progress. Clinical Oncology

摘要

Randomized clinical trials have a relatively brief history, and the implementation of structured interim-monitoring plans is even more recent, with the majority of developments related to group sequential methods taking place beginning in the 1970s and gaining wide adoption in the 1980s.1 These ideas were readily taken up in oncology2'3; indeed, early in its history the Journal of Clinical Oncology featured articles describing what were essentially policy statements regarding the conduct of interim monitoring in cancer clinical trials.4'5 In those articles, principles were laid out for incorporation of appropriate interim-monitoring plans into the trial design, establishment of a data-monitoring committee that is empowered to act with authority on information obtained from interim analyses, and-most relevant to this discussion-limits on access to the interim-analysis results to the data-monitoring committee until such time that results are definitive or other circumstances dictate that the trial shouldbe closed.