Prioritizing and Supporting Trials
The increasingly complex environment in which cancer clinical trials are conducted has created considerable challenges for the Cooperative Group Program. Inefficient interactions among the various stakeholders are contributing to delays in the system. To increase the speed of advances in oncology care, NCI should shift its primary focus from oversight to the facilitation of Cooperative Group trials. As part of this effort, NCI should streamline processes for prioritizing, selecting, and supporting clinical trials and for enrolling patients quickly after a trial is launched. Participating sites should be credentialed to enroll patients in any high-priority trial, and sites with low patient accrual should be eliminated.
NCI should allocate a larger portion of its research portfolio to the Cooperative Group Program. However, the trial prioritization and selection process should be strengthened so that only well-designed clinical trials that have the greatest possibility of improving survival and quality of life for cancer patients are undertaken. Launching only the highest-ranked trials would improve quality, speed advances, and ensure that patients are enrolling in the most meaningful and potentially beneficial trials.
Patient and Physician Participation
A robust clinical trials infrastructure depends on a critical mass of physicians and patients willing to participate. But participation is not the norm today. Participation in clinical trials requires substantial resources and support staff. Clinical investigators and sites are not adequately reimbursed for the costs of participating in Cooperative Group trials. Moreover, the current system does not adequately reward collaborative work, and at academic medical centers, clinical investigation often is accorded less value than either basic research or patient care. Given the limits in funding and capacity of the system, it is unrealistic to expect all or most clinicians to participate in trials, but those who are motivated to do so should be supported and encouraged. NCI and other stakeholders should explore and expand approaches for reducing career and financial concerns, such as providing salary support for protected research time.
Even if patients are eligible for trials and are informed about the option by their physicians, they may decline participation because of financial concerns, as coverage of patient care costs in clinical trials by health insurers is inconsistent. Among other actions, federal and state health benefits plans, private health insurers, and the Centers for Medicare and Medicaid Services should establish consistent payment policies to cover patient care costs (except for specific study-related costs that should be paid for by the drug or device manufacturer) in clinical trials approved through the NCI prioritization mechanism. As a quid pro quo, private insurers should be able to eliminate coverage of experimental therapies delivered outside of the clinical trial setting, but any such limitation in coverage should not affect off-label use that is backed by evidence from clinical trials published in the scientific literature, as evidence-based off-label use constitutes the standard of care for many cancer therapies and is therefore not experimental.
Improved treatments for cancer will be delayed and patient lives will be lost unnecessarily unless the efficiency and effectiveness of the clinical trials system improves. The implementation of the report’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. Modifying any single element of the Program or the clinical trials process will not suffice; changes across the board are urgently needed. All stakeholders, including physicians, patients, and health care insurers, as well as NCI, other federal agencies, academia, foundations, and industry, must reevaluate their roles and responsibilities in cancer clinical trials and work together to develop an improved, efficient multidisciplinary trials system. The health of nearly 1.5 million patients diagnosed with cancer in the U.S. each year depends on these efforts.