Outreach efforts to inform ethnic minority groups and populations with low literacy levels about clinical trials include versions of the NCI publication What Are Clinical Trials all About? in Spanish and in a version for people with low literacy levels, and a Spanish-language version of the videotape Patient to Patient: Cancer Clinical Trials and You. Fact sheets on cancer prevention and treatment studies have been developed in both English and Spanish. Similarly, a new training program for health professionals that addresses common patient concerns about the trial process, from initial decision making to trial participation and follow-up was developed in English and Spanish.
To address the increasing complexity of the informed-consent process, representatives from NCI, the Office of Protection from Research Risks, and the Food and Drug Administration have organized a working group charged with developing recommendations to make the informed-consent process more understandable. Informed-consent documents are lengthy, complex, and often difficult to understand, thereby hindering the process of providing accurate information to potential subjects. The working group developed recommendations for an informed-consent template and sample consent documents that are undergoing field testing.
NCI's Cancer Therapy Evaluation Program provided supplemental funding in fiscal year (FY) 1997 for 5 of the 11 Clinical Trials Cooperative Groups (see below for description) as part of an initiative to increase the accrual of ethnic minority populations. Funds were used to support focus groups and educational opportunities for ethnic minority health professionals, to advertise and support outreach efforts in ethnic minority communities, to hire translators, and to conduct other community-based education efforts.
To increase the number of ethnic minority patients enrolled in Community Clinical Oncology Programs (CCOPs), NCI developed the Minority-Based Community Clinical Oncology Programs (MBCCOPs) in 1990. The MBCCOP involve more than 300 physicians and eight program sites located in areas with large minority populations, such as San Juan, Puerto Rico; Mobile, Alabama; Honolulu, Hawaii; and San Antonio, Texas.
The NIH Office of Research on Minority Health (ORMH; see Chapter 3) has provided funding to the NCI Cancer Center Program to support programs and personnel to increase the accrual of ethnic minorities in cancer center trials. These funds have supported the hiring of personnel involved in minority recruitment efforts, such as translators, data managers, bilingual patient liaisons, and others and have supported activities such as the development of recruitment brochures specifically targeted to ethnic minority patients.
Finally, NCI has sponsored several conferences to promote strategies for the development and sharing of information among investigators to