increase ethnic minority accrual. NCI released a request for applications in 1996 to support regional conferences on the recruitment and retention of ethnic minorities in clinical trials. Eleven such conferences were funded to address particular issues for investigators and patient populations at each locality. These regional conferences followed a national conference entitled Recruitment and Retention of Minority Participants Clinical Cancer Research, held in Washington, D.C., that was cosponsored by the American Cancer Society (ACS), the Oncology Nursing Society, the NIH Office of Research on Women's Health, and ORMH, among others. A monograph of the conference proceedings outlining specific needs and strategies for recruitment and retention of ethnic minority and underserved populations was published by NCI (see Box 5-1).
As noted in Chapter 3, NCI sponsors approximately 500 clinical trials, including those of the Clinical Trials Cooperative Groups and CCOP, intramural clinical trials, and trials conducted at NCI-funded cancer centers. The Clinical Trials Cooperative Group Program performs more than half of the NCI-sponsored trials, conducting approximately 900 of the 1,500 trials. Thirteen cooperative groups that included participants from 194 universities and 1,839 hospitals and more than 23,700 physicians were funded in 1977. CCOP links community-based physicians with Clinical Trials Cooperative Groups and cancer centers for cancer prevention and treatment trials. More than 50 community-based programs in 30 states, nine cooperative groups, and three cancer centers were funded in 1997 and involved more than 300 hospitals and 3,300 physicians. Finally, NCI sponsors four large cancer prevention trials, described in greater detail below and in Chapter 3: the atypical squamous cells of undetermined significance (ASCUS) or low-grade squamous intra-epithelial lesions (LSIL) Triage Study (ALTS) of cervical cancer screening, evaluation, and management; the Prostate, Lung, Colorectal, and Ovarian Cancer (PLCO) Screening Trial; the Prostate Cancer Prevention Trial (PCPT); and the Breast Cancer Prevention Trial (BCPT). The levels of ethnic minority accrual in these trial groups are summarized below. Except in a few instances as noted below, NCI and the trial groups did not report on accrual by socioeconomic status or other indicators of medically underserved populations.
Determinations of whether the level of accrual of ethnic minorities into trials is proportionate to cancer burden can typically be accomplished by comparing the percentage of cancer diagnoses among racial and ethnic groups in the U.S. population within a given time frame and the percentage of minority enrollment within trials for each cancer studied. Such