Defining “Success” in recruitment of underrepresented populations to cancer clinical trials

Abstract

Although medically underserved groups bear a heavy burden of cancer disease and governmental agencies have required inclusion of minorities and women in cancer clinical trials since 1993, many of these groups are underrepresented in cancer prevention or treatment clinical trials. To assess and enhance recruitment of underrepresented populations into cancer-related clinical trials, investigators and governmental agencies need consistent measurement approaches for recruitment that can be applied to diverse settings where trials are conducted. We conducted a systematic review to evaluate what measurement approaches were used to evaluate the success of recruitment of underrepresented groups into cancer prevention or treatment trials, and whether these recruitment goals were stated a priori. Only two articles reported an a priori recruitment goal. The recruitment measurement approaches varied considerably, with no consistent standard, especially for individual trials. By using the empiric evidence from this review in conjunction with the National Institutes of Health (NIH) guidelines, we constructed a framework for choosing consistent a priori recruitment goals for underrepresented groups based on the research question and study location. Using consistent measurement approaches for underrepresented groups will improve comparability of recruitment strategies across trials, improve equity in distribution of benefits and burdens of cancer-related clinical trials, and may improve applicability of trial results to multiple populations.

Recruitment and retention strategies in clinical studies with low-income and minority populations: Progress from 2004–2014

“…One of the most difficult aspects of the review was comparing recruitment strategies across studies that used different language, i.e., enrollment, recruitment, participant, registrant. Using consistent measurement approaches for underrepresented groups would greatly improve comparability of recruitment strategies across trials and may improve applicability of trial results to multiple populations [61].…”

A Prospective Analysis of the Influence of Older Age on Physician and Patient Decision-Making When Considering Enrollment in Breast Cancer Clinical Trials (SWOG S0316)

“…It is critical that investigators develop a priori recruitment goals for patients Ն65 years of age when designing a therapeutic clinical trial. A framework for deciding upon a recruitment goal has been outlined by Bolen et al, which takes into consideration the current adequacy of care, burden of disease among groups, and the known biologic or cultural differences between groups [28]. It has been successfully demonstrated by Moinpour et al in a prostate cancer randomized controlled prevention trial that set an a priori recruitment goal for African American men based upon the national proportion of African American men in the age subset they were evaluating [29].…”

Recruiting Vulnerable Populations into Research: A Systematic Review of Recruitment Interventions

“…13,18 There is also a question of the methodologic rigor of trial enrollment studies, as prior work has suggested that studies of recruitment interventions vary in their definition of successful recruitment, and others have called for more complete reporting of racial, ethnic and cultural composition of subjects in trials as well as thorough descriptions of recruitment successes and failures. 13,21 We therefore conducted a systematic review to identify which minority recruitment strategies have been attempted and which ones are effective and efficient. We also assessed the methodologic rigor of these studies with regard to quantitative and qualitative data reporting and ability to draw inferences.…”