Assuring access to state-of-the-art care for U.S. minority populations: the first 2 years of the Minority-Based Community Clinical Oncology Program.

ABSTRACT

BACKGROUND: The Minority-Based Community Clinical Oncology Program (MBCCOP) was initiated in September 1990 to expand the National Cancer Institute's (NCI's) clinical trials network to minority populations. Institutions, organizations, and/or physician groups that had more than 50% of new cancer patients from minority groups were eligible to participate. There has been no previous evaluation of the MBCCOP. PURPOSE: This study was designed to describe the early implementation of the MBCCOP and identify the challenges that have emerged in developing a network aimed at increasing the participation of minority populations in clinical trials. METHODS: Data were taken from primary and secondary sources, including site visits and patient log data, that described performance of 12 MBCCOP centers initially funded in September 1990. Accrual was measured by the number of credits earned per MBCCOP for patients enrolled in research protocols for cancer treatment or for prevention and control, which includes activities such as early detection, pain control, and rehabilitation. These accrual credits, assigned by the NCI, were based on the complexity of the protocol and the amount of resources expected to be required for accrual of patients by the MBCCOP. RESULTS: Data for the first 2 years of the MBCCOP showed that 344 patients were accrued to trials of treatment protocols from June 1, 1990, to May 31, 1991, and this number increased to 470 during the second accrual year, June 1, 1991, to May 31, 1992. Similarly, accrual of patients to cancer prevention and control studies increased from 256 in 1990-1991 to 423 in 1991-1992. More than 70% of the MBCCOP patients entered in studies were from minority populations. The proportion of eligible MBCCOP patients entered into treatment protocols was identical with that experienced by the initial Community Clinical Oncology Program (CCOP). Results also demonstrated that MBCCOP centers operate in an environment characterized by socio-economic decline and limited resources, both having substantial effects on the implementation of clinical trials among minorities. While minority patients are willing to participate in clinical trials, there are profound barriers involving language, logistics, and the appropriateness of available protocols. Participating physicians, nurses, and support personnel report a high level of agreement with program goals and have developed unique approaches to meeting the challenges faced in the implementation of this program. CONCLUSIONS: The MBCCOPs have demonstrated their ability to participate in clinical trials. Evaluation reveals, however, that they are emerging organizations influenced by factors endemic to the community they serve and their own structure. The MBCCOPs are confronting substantial challenges, yet they provide an important link to the overall NCI clinical trials network.