National Cancer Institute
National Cancer Institute U.S. National Institutes of Health


“This is not just about getting the clinical trial groups properly retrofitted or making things run more quickly, it’s about injecting a new kind of science into the way we do clinical trials.” Harold Varmus, M.D., Director, NCI, September 7, 2010

For over 50 years, NCI has supported a standing infrastructure — the NCI Clinical Trials Cooperative Group Program — to conduct large scale cancer clinical trials across the nation, with successful completion of many important trials that have led to new treatments for cancer patients. Over time, however, oncology has evolved into a more molecularly-based discipline including genetic sub-classification of tumors and individualized treatments. It is truly an exciting time in oncology research, and we are presented with immense scientific opportunities to be systematically explored. NCI must ensure that the Cooperative Groups are optimally situated and well-prepared to design, enroll and complete state-of-the-art trials for cancer patients.

Transforming the NCI Clinical Trials Cooperative Group Program

The 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, and 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 on improvements.

Learn more about the process NCI has put in place to take the beginning steps in transforming the Cooperative Group Program

Designing a More Efficient National Clinical Trials System: Progress Related to the IOM Recommendations (2010)

The IOM Report highlighted 4 major goals for a National Clinical Trials System for the 21st century:

  1. improve the speed and efficiency of the design, launch, and conduct of clinical trials
  2. incorporate innovative science and trial design into cancer clinical trials
  3. improve prioritization, selection, support, and completion of clinical trials
  4. incentivize the participation of patients and physicians in clinical trials

NCI has made progress related to many of the goals and recommendations included in the IOM Report on the Cooperative Group program.

Learn more about the progress NCI has made in accomplishing these four major IOM goals