The Cooperative Groups: past and future.

Abstract

The Cooperative Group system of the National Cancer Institute (NCI) has been in existence since the 1950s and has evolved to comprise 11 groups, the membership of which includes universities, Community Clinical Oncology Programs, and Cooperative Group Outreach Programs. The Cooperative Groups serve as models for cancer clinical trials throughout the world. However, in today's changing healthcare environment in the USA the Cooperative Groups need to adjust how they operate to ensure the continuation of their leadership role in cancer clinical trials. Government funds, the main source of support for the Cooperative Groups' activities, are shrinking and currently funding is only 50% of the recommended level. If the Cooperative Groups are to remain at the forefront, adjustments must be made in several areas: the Cooperative Groups need to provide an efficient and rapid scientific and legal mechanism to execute large phase III studies of the increasingly important portfolio of compounds being developed by industry more effectively. Industry has come to rely on contract research organizations for expedited testing of their products due to perceived inefficiency in these areas in the Cooperative Group mechanism. The Cooperative Groups are uniquely situated to provide in-depth evaluation of the newest therapies for regulatory agencies and interested health insurers, as well as provide health outcomes data, which are now much sought after by the healthcare industry. Managed care is shaping medical practice, including cancer care, throughout the USA. Finally, the Cooperative Groups need to foster greater international cooperation to speed technology transfers. The leaders of the Cooperative Groups are discussing new approaches to address these deficiencies, while complementing the existing NCI structure and recognizing the independence of each group. The objectives of these new approaches would be: to establish a structure whereby better contracts with industry for conducting trials can be established; to enhance international cooperation in clinical trials; to encourage greater involvement of third-party payers in clinical trials; to build on the scientific breadth of the members; to identify the most appropriate therapies to consider for reimbursement; to establish a framework which builds on the strengths of each of the members; and to integrate health outcomes and economic measures into the protocol activities. The Cooperative Groups are making changes to ensure they remain the leaders in cancer clinical trials well into the 21st century. The benefits of these adjustments will be realized not only by patients, but also by health professionals and the healthcare industry.