Although many important clinical trials are undertaken by the pharmaceutical industry, relying solely on pharmaceutical companies and contract research organizations to maintain a clinical trials infrastructure would be detrimental for a variety of reasons. First, companies are primarily responsible to their shareholders and have less incentive to conduct certain types of clinical trials that are in the best interests of society. An industry-only clinical trials infrastructure may neglect important areas of research, including research on the comparative effectiveness of different therapeutics, research on novel indications for older drugs, determination of dose intensity, the development of combination products from multiple companies, research on the development of drugs for the treatment of rare diseases, evaluation of different surgical and radiation treatment methods, research on screening and prevention strategies, and research on rehabilitation and quality of life following therapy. In addition, industry trials are increasingly moving away from the United States (Agres, 2005; Glickman et al., 2009; IOM, 2009b; Normile, 2008), which could lower U.S. patient access to clinical trials and, in some instances, lower the applicability of the findings of clinical trials to the U.S. population. This movement of clinical trials overseas threatens the capacity of the United States to maintain a clinical trials infrastructure and workforce. Academic centers and community practices play a crucial role in training and mentoring the next generation of clinical investigators, but recent evidence suggests that the number of U.S.-based principal investigators is declining (Getz, 2007), potentially shrinking the training pipeline for new clinical investigators and negatively affecting the U.S. economy.

Rather than rely on a pharmaceutical industry-centered clinical trials infrastructure, the committee concluded that incentives must be realigned so that clinical investigators and patients will choose to participate in a publicly sponsored clinical trials system. The committee took a broad view of the disincentives preventing high rates of participation. For clinical investigators, the committee emphasized issues related to reimbursement, extensive regulatory burdens, and academic procedures related to tenure, promotion, and career development. For patients, the committee discussed third-party coverage for participation in clinical trials and patient and physician attitudes about participation in clinical trials, including knowledge of the availability of clinical trials. Many of these issues have been addressed in prior evaluations of the Clinical Trials Cooperative Group Program (NCI, 1997, 2005b), but low rates of participation in cancer clinical trials remains a significant barrier to the efficient translation of scientific discoveries into advances in patient care.

CLINICAL INVESTIGATOR PARTICIPATION

Retaining a workforce competent in conducting clinical trials is essential to maintaining a strong publicly funded clinical trials infrastructure.



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