Twenty Years Post- NIH Revitalization Act: Enhancing Minority Participation in Clinical Trials ( EMPaCT): Laying the Groundwork for Improving Minority Clinical Trial Accrual

BACKGROUNDThe National Institutes of Health (NIH) Revitalization Act of 1993 mandated the appropriate inclusion of minorities in all NIH-funded research. Twenty years after this act, the proportion of minority patients enrolled in cancer clinical trials remains persistently low. Clinical trials are vehicles for the development and evaluation of therapeutic and preventive agents under scientifically rigorous conditions. Without representation in trials, it is projected that disparities in the cancer burden for minorities will increase. METHODSFor this review article, the authors counted the frequency with which minorities were the primary focus of National Cancer Institute-sponsored clinical trials, examined citations from the PubMed database focusing on the search terms NIH Revitalization Act of 1993 and enhancing minority accrual to cancer clinical trials, and supplemented the review with their expertise in NIH-funded research related to minority accrual in cancer clinical trials. RESULTSThe reporting and analyses of data based on minorities in clinical trials remain inadequate. Less than 2% of the National Cancer Institute's clinical trials focus on any racial/minority population as their primary emphasis. The current review of the literature indicated that the percentage of authors who reported their study sample by race/ethnicity ranged from 1.5% to 58%, and only 20% of the randomized controlled studies published in a high-impact oncology journal reported analyzing results by race/ethnicity. Proportionately greater population increases in minorities, accompanied by their persistent and disproportionate cancer burden, reinforce the need for their greater representation in clinical trials. CONCLUSIONSRenewing the emphasis for minority participation in clinical trials is warranted. Policy changes are recommended. Cancer 2014;120(7 suppl):1091-6. (c) 2014 American Cancer Society. Twenty years have elapsed since the 1993 National Institutes of Health (NIH) Revitalization Act mandated the appropriate inclusion of minorities in all NIH-funded research. Despite this legislation, minority accruals to cancer clinical trials persist at a rate below 5%, and the cancer burden has increased; recommendations for amelioration are proposed.