Report at a Glance
A National Cancer Clinical Trials System for the 21st Century: Reinvigorating the NCI Cooperative Group Program
Advances in biomedical research continue to create significant opportunities for improving the detection, treatment, and prevention of cancer. But generating knowledge is only a start. Clinical trials that test the safety and therapeutic benefit of promising treatments are essential in translating new knowledge into tangible benefits for patients with cancer—the second leading cause of death in the United States, behind heart disease.
For the past 50 years, the National Cancer Institute’s (NCI) Clinical Trials
Cooperative Group Program has played a key role in developing new and improved cancer therapies. The program’s 10 Cooperative Groups conduct clinical trials through networks of cancer centers and community oncology practices across the country. More than 25,000 patients and thousands of clinical investigators participate in the program’s clinical trials annually. Its efforts complement the clinical trials that pharmaceutical and biotechnology companies conduct, particularly by addressing questions that are less likely to be among industry’s top priorities. In recent years, however, many stakeholders—
including clinical investigators, patient advocates, Cooperative Group leadership, industry participants, as well as the NCI—have expressed concerns
that the program is falling short of its potential to conduct the timely, large-scale, innovative clinical trials needed to improve patient care. As a result, NCI asked the Institute of Medicine (IOM) to assess the state of cancer
clinical trials, review the Cooperative Group Program, and provide advice