The purpose of this workshop was to discuss the possibilities for improving the efficiency and effectiveness of phase III clinical trials as conducted by the Cooperative Groups Program. Speakers and discussants had the opportunity to suggest potentially transformative steps that may be taken to address the challenges faced by the research institutions and health-care providers working to create the highest-quality cancer treatments for their patients.
For more than 50 years, NCI Cooperative Groups have united cancer centers, academic medical institutions and community hospitals in the pursuit of new cancer treatments. The Cooperative Group Program has grown to include 1,700 separate institutions under 12 groups that recruit about 22,000 patients to cancer clinical trials each year. Because of their public and academic nature, it has been possible for the cooperative groups to conduct clinical trials that extend beyond the usual focus and capacity of pharmaceutical companies, including trials on methods of cancer prevention and early detection, patient quality-of-life, and new trial designs for combination therapies and proof-of-concept studies.
Nonetheless, due in part to eroding financial support and increasing regulatory burdens, the program has been increasingly described as unwieldy, inefficient, slow, and underfunded. In the last several years, the budget of the Program has flat-lined so that it has lost ground to inflation and supports a shrinking minority of the costs of trials. These problems are particularly acute with respect to phase III clinical trials, such that some physicians and clinical research staff choose not to participate in the trials and that many of the trials are never published. In the face of these challenges, NCI has struggled to determine ways to improve the Cooperative Groups Program. Despite internal and external review of the program, it has remained essentially unchanged over its existence, except for the gradual increases of regulations and oversight.