Clinical Trial Investigator Status: You Need to Earn It

Abstract

The clinical trials that are conducted by the National Cancer Institute (NCI) represent the core of the clinical program of the NCI’s Center for Cancer Research. At the Center for Cancer Research, clinical and basic science are integrated with the goal of reducing the burden of cancer through discovery, exploration, and bench-tobedside translational treatment and prevention modalities. The goal of the NCI clinical trials program is to answer questions about particular cancers and to identify new therapeutic and prevention interventions, which are performed across the United States at centers participating in NCI-supported research. Sadly, only 2% to 7% of adult patients with cancer across the United States participate in these clinical trials. To make matters worse, the following populations are under-represented among participants in NCI-funded clinical trials: Latinos/Hispanics, Asian and Pacific Islanders, African American men, American Indians/Alaskan Natives, adolescents, older adults (age 65 years), individuals who reside in rural areas, and individuals of low socioeconomic status. The lack of diversity in clinical trials populations reduces the opportunity for discovering effects that may be relevant to a particular under-represented population. The literature has focused on barriers to participation in clinical trials—including both physician and patient issues—such as cost, lack of support personnel, limited access to clinical trials, and the distance that patients may live from centers that participate in NCI clinical trials. In a study by Meropol et al, cognitive, affective, and practical barriers to participation in clinical treatment trials were characterized among Pennsylvania oncologists. Eligible physician participants were practicing medical oncologists in Pennsylvania, and eligible patients were adults at least 18 years of age with cancer undergoing follow-up by medical oncologists in Pennsylvania. Of 137 oncologists and 170 patients who completed the surveys, of patients, 84% were aware of clinical trials, and both oncologists and patients generally agreed that clinical trials were important to improve cancer treatment. It was interesting that oncologists and patients in this report were more likely to consider clinical trials in advanced or refractory disease. When considering seven potential barriers to clinical trials, random assignment and fear of receiving a placebo were highly ranked by both patients and oncologists. Patients identified fear of adverse effects as the greatest barrier to clinical trial participation, whereas oncologists ranked this psychosocial barrier as of least importance to their patients. Although the study found that oncologists and patients in Pennsylvania were aware of clinical trials and had favorable attitudes toward them in principle, psychosocial barriers existed for patients that more than likely reduced participation. One of the key issues in this study was the fact that the oncologists who were surveyed had favorable attitudes toward clinical trials. Surely, there must be oncologists who don’t have favorable attitudes toward clinical trials and are not advocates of clinical trials. This is reflected in the fact that 30% of oncologists are responsible for 70% of the accrual to NCI clinical trials. Although some important pragmatic issues, such as fiscal and administrative support, may affect participation, these are issues that affect all oncologists to varying degrees, yet some oncologists are more successful than others in accruing patients to clinical trials. As reported by the Coalition of Cooperative Groups, community-based practices are responsible for 64% of adult patients accrued in cooperative group–sponsored clinical trials. Academic centers are responsible for 34%, whereas military/Veteran’s Administration hospitals contribute the remaining 2%. Hence, the NCI Community Clinical Oncology Programs (CCOPs) play a major role in adult recruitment to NCI-sponsored clinical trials. Created in 1983 by the National Cancer Institute, the CCOP network allows patients and physicians to participate in state-of-the-art clinical trials for cancer prevention and treatment in their local communities. There are 50 CCOPs and 13 minority-based CCOPs currently funded in 35 states across the United States, the District of Columbia, and Puerto Rico. The Delaware Christiana CCOP was initially funded in 1987. After a restructuring of the cancer program at the Helen F. Graham Cancer Center at Christiana Care in 2001, accrual to NCI clinical trials increased from 9.9% in 2001% to 20% in 2006. There are many reasons for this dramatic increase in clinical trial accrual over a 5-year period, which represents six times the national average. All the reasons for this increase in patient accrual to NCI clinical trials are beyond the content of this article. Briefly, however, this increase has been partly due to the establishment of multidisciplinary disease site centers, placing clinical research nurses in the private practice offices, with a continuous marketing campaign. Nevertheless, despite the improvement of this clinical trials accrual, there is a core of physicians participating in the cancer program whose track record to clinical trial accrual can best be described as dismal. This is despite the fact that there are more than 110 clinical trials available for their patients covering every disease site, with personnel support to help in the recruitment to clinical trials. These individuals are designated members of the NCI Cooperative Groups and many have membership in cooperative groups on their curriculum vitaes. Some investigators have suggested that access to clinical trials should be an objective and a component of state-of-the-art cancer JOURNAL OF CLINICAL ONCOLOGY COMMENTS AND CONTROVERSIES VOLUME 26 NUMBER 15 MAY 2