National Cancer Institute-sponsored cooperative groups: changing process to speed progress.

Recent independent analyses of the National Cancer Institute’s (NCI) clinical trials systems have indicated an urgent need to re-evaluate ingrained processes and to find novel solutions if investigators are to take full advantage of the scientific opportunities available today for clinical research.1-3 The NCI-sponsored Cooperative Groups remain NCI’s primary outlet for phase III definitive trials in cancer prevention, control, and treatment.4 Cooperative Groups have the significant advantage of maintaining a regulatory and operational foundation that is readily available and fully experienced in the conduct and coordination of large, multicenter trials. This infrastructure has undergone a series of changes since 2000 that have positively affected Group operations. Some of the most important ones include the pivotal role of the Cancer Trials Support Unit (CTSU), the NCI’s Central Institutional Review Board (CIRB), and the recently introduced Disease-Specific Steering Committees (DSSC). In order for these projects to achieve their aims, however, increased attention must be devoted to the numerous processes underlying clinical trial development.