educate patients about the availability and value of clinical trials. Educational efforts should focus on making the general population more aware of clinical trials. One reason is that it can be difficult for patients to sort through a large volume of new information and make complex decisions just after they have received a diagnosis of a life-threatening illness. Patients often lack comprehensive and reliable information about clinical trials and may not be able to identify the trials for which they might be eligible. Patients value reliable information from trusted sources, including family members, so appropriate education efforts could provide useful information that would allow patients to make informed choices about participation in a clinical trial. In addition, as noted in more detail in Recommendation 9, user-friendly electronic tools would increase awareness of clinical trials and make it easier for physicians and patients to enroll in the most appropriate studies.
Collectively, the implementation of these recommendations would reinvigorate the Clinical Trials Cooperative Group Program for the 21st century and strengthen its position as a critical component of the translational pathway from scientific discovery to improved treatment outcomes for patients with cancer. Modifying any particular element of the Program or the clinical trials process will not suffice; changes across the board are urgently needed. All participants and stakeholders, including physicians, patients, and health care insurers, as well as NCI, other federal agencies, academia, foundations, and industry, must reevaluate their current roles and responsibilities in cancer clinical trials and work together to develop a more effective and efficient multidisciplinary trials system.
The Cooperative Group Program is beset by serious problems, but they are not intractable. The committee envisions a system that retains the current strengths, but moves beyond collaboration to integration, with reorganized structures and operations in a truly national clinical trials network and with sufficient funding and support to enable the rapid completion of well-designed, high-priority cancer clinical trials that advance patient care.