A National Cancer Clinical Trials System for the 21st Century: Reinvigorating the NCI Cooperative Group Program


Report at a Glance

Advances in biomedical research continue to create significant oppor­tunities for improving cancer detection, treatment, and prevention. 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. 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. More than 25,000 patients and thousands of clinical investigators participate in the program’s clinical trials annually. In recent years, however, many stakehold­ers 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 IOM to assess the state of can­cer clinical trials, review the Cooperative Group Program, and provide advice on improvements.

The IOM recommends changes that aim to transform the Cooperative Group Program into a dynamic system that effi­ciently responds to emerging scientific knowl­edge; involves broad cooperation of stakeholders; and leverages evolving technologies to provide high-quality, practice-changing research. The program should maintain a robust, standing cancer clinical trials network by preserving its histori­cal strengths while improving components that are not work­ing well. Four overarching goals should guide improvement efforts:

  • Improving the speed and efficiency of the design, launch, and conduct of clinical trials
  • Making optimal use of scientific innovations
  • Improving selection, prioritization, support, and completion of clinical trials
  • Fostering expanded participation of both patients and physicians

The implementation of the IOM’s collective recommendations will reinvigorate the NCI Clinical Trials Cooperative Group Program and strengthen its position as a critical component of the translational pathway from scientific discov­ery to improved treatment outcomes for patients with cancer.