of accomplishments, the Cooperative Group Program is facing numerous challenges that threaten its ability to continue to undertake large-scale, innovative trials that benefit patient care. Confronting these challenges is essential. A national cancer clinical trials enterprise is necessary “to ensure that the advances in understanding the biological basis of cancer, generated by the past 40 years of research, are harnessed effectively to bring measurable, meaningful benefits to patients” (NCI, 2005).

IMPORTANCE OF CANCER CLINICAL TRIALS

Clinical trials are essential for establishing the evidence base that the oncology community uses to make treatment decisions and to determine the direction of future clinical research. By evaluating the safety and efficacy of new therapies, comparing the effectiveness of existing therapies, and assessing different prevention, screening, and detection strategies, clinical trials are responsible for setting the standard of patient care. In fact, today’s most effective therapies began as hypotheses tested within the clinical trials environment (C-Change and Coalition of Cancer Cooperative Groups, 2006). Clinical trials also provide fundamental information about the biology of cancer, which investigators leverage to advance preclinical research and drug development.

Numerous stakeholders conduct clinical trials with various goals across the spectrum of research. While industry trials primarily focus on drug discovery and development activities with the potential for a substantial return on investment, publicly sponsored trials have a more diverse portfolio, from small, proof-of-concept Phase I and II studies that typically enroll patients with metastatic disease who have already had one or more lines of therapy to large Phase III studies that may focus on adjuvant or neoadjuvant therapy, first-line therapy for metastatic disease, or prevention strategies. Publicly sponsored trials are also more likely to study less common cancers that are not often a focus of industry research and development.

The National Cancer Institute (NCI) supports the largest U.S. network for clinical trials of any type through the use of several different funding mechanisms. NCI supports individual trials through grant mechanisms and research contracts, funds programs that use clinical trial data to advance preclinical research, and also partially funds cancer centers that conduct clinical trials as a component of their overall research and patient care activities. In addition, NCI supports trials through cooperative agreements, such as the Clinical Trials Cooperative Group Program. The various recipients of the funds provided by the use of these different funding mechanisms bring different strengths to the research portfolio.

The largest component of the NCI-supported clinical trials portfolio is the Clinical Trials Cooperative Group Program. The Cooperative Group



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