Only 2-4% of all adult patients with newly diagnosed cancer participate in clinical trials, including early phase studies, annually. In addition, representation of minorities and the elderly in clinical trials has been low. Low accrual rates have a negative impact, prolonging trial duration, delaying analysis of results, or leading to early study closure. Barriers to patient enrollment must be identified and overcome to increase accrual. Work by UC Davis investigators and others have identified several barriers, including misperceptions, misinformation, an ethnically homogenous population, geographic and data management problems, reimbursement issues, and physician bias, which may translate into deficient interactions with patients. This proposal will explore and address the issues surrounding early phase trial accrual through an intensive investigation of barriers encompassing various layers of cancer care access: from macro-level, population-based information-gathering and dissemination strategies to meso-level efforts in overcoming eligibility/clinical trial design barriers, to micro-level interaction-based barriers. The overall hypothesis of this two-year plan is that patient accrual into early phase trials will be enhanced by developing and testing interventions to overcome these barriers, and will be addressed through the following three objectives: 1) To increase patient, public, and physician awareness of early phase clinical trials and the attendant reimbursement issues; 2) To develop a novel phase I trial design that enhances patient access to novel investigational anti-cancer agents; 3) To improve communications between patients, family, health care providers, and the clinical trials research team. This proposal is strengthened by the expertise of a multi- disciplinary team (medical oncology, cancer control, health services research and communications, bioethics, sociology, epidemiology, marketing, and advertising, among others), led by Principal Investigator Dr. Primo N. Lara, Jr., MD. To oversee the conduct of this 2-year research plan, a Barriers Steering Committee (BSC) comprised of established leaders in cancer control and health services research will be organized. The underserved, minority, elderly, and women populations, and where possible, children will be specifically targeted where appropriate, to increase their participation in early phase trials.
