Twenty years post‐NIH Revitalization Act: Enhancing minority participation in clinical trials (EMPaCT): Laying the groundwork for improving minority clinical trial accrual

Abstract

Background The NIH Revitalization Act of 1993 mandated the appropriate inclusion of minorities in all National Institutes of Health-funded research. Twenty years after this Act, the proportion of minority patients enrolled in cancer clinical trials remains persistently low. Clinical trials are the vehicles for the development and evaluation of therapeutic and preventive agents under scientifically rigorous conditions. Without representation in trials, disparities in the cancer burden for minorities are projected to increase. Methods In this review paper, authors counted the frequencies in which minorities were the primary focus of National Cancer Institute-sponsored clinical trials, examined citations from PubMed 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. Results The reporting and analyses of data based on minorities in clinical trials remain inadequate. Less than two percent of the National Cancer Institute's clinical trials focus on any racial/minority population as their primary emphasis. Our review of the literature indicated that the percentage of authors who reported their study sample by race/ethnicity ranged from 1.5% to 58.0%; only 20% of the randomized controlled studies 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. Conclusions Renewing the emphasis for minority participation in clinical trials is warranted. Policy changes are recommended.

Medical research: Missing patients

“…Although black people and other minorities in the United States have greater rates of and mortality from cancer than white people 2 , they are generally less likely to be enrolled in clinical trials. Of the 10,000 clinical trials funded by the National Cancer Institute since 1993, only around 150 studies focused on racial or ethnic minorities 8 . Such gaps and their effect on health care must be assessed.…”

The Ethics of Clinical Trials for Cancer Therapy

“…Amid the general concern about low rates of participation in adult oncology trials, there have been recent calls to reinvigorate and reemphasize the recruitment of ethnic minorities to participate in cancer clinical trials, because the persistently low participation rates among these groups is thought to be associated with ongoing disparities in outcomes [11]. In pediatric oncology, rates of clinical trial participation have historically been very high, and the ability to learn from virtually every patient is credited with being part of the reason for the high cure rates achieved in pediatric cancers over the past several decades [12].…”

Incorporating cultural values and use of technology platforms may help outreach Asian Americans in cancer clinical trial participation

“…[1,2] Asian Americans are the fastest growing racial group in the U.S. and account for 6.3% of the population. [3] Chinese (22.5%) and Filipino (18.5%) are among the largest Asian American groups.…”

“…[7] However, only 1.7% of cancer clinical trial participants are Asian Americans and Pacific Islanders (AAPI). [8] Addressing these disparities in cancer clinical trials is a pressing national priority. [1,7] Studies on Asian Americans have shown evidence of cultural differences in belief and attitude, [9,10] healthcare decision-making [11,12] and perception regarding clinical trial participation.…”

“…[1,[13][14][15][16][17][18][19] Despite growing body of findings related to clinical trial participation, enrollment into clinical trials from Asian Americans remains low. [8] This paper aims to describe findings from a pilot study on barriers, promoters of and recommendations for cancer clinical trial participation among Chinese, Filipino and Hmong Americans.…”