Impact and costs of targeted recruitment of minorities to the National Lung Screening Trial

Background To promote results in the National Lung Screening Trial (NLST) that are generalizable across the entire US population, a subset of NLST sites developed dedicated strategies for minority recruitment. Purpose To report the effects of targeted strategies on the accrual of underrepresented groups, to describe participant characteristics, and to estimate the costs of targeted enrollment. Methods The 2002–2004 Tobacco Use Supplement was used to estimate eligible proportions of racial and ethnic categories. Strategic planning included meetings/conferences with key stakeholders and minority organizations. Potential institutions were selected based upon regional racial/ethnic diversity and proven success in recruitment of underrepresented groups. Seven institutions submitted targeted recruitment strategies with budgets. Accrual by racial/ethnic category was tracked for each institution. Cost estimates were based on itemized receipts for minority strategies relative to minority accrual. Results Of 18,842 participants enrolled, 1576 (8.4%) were minority participants. The seven institutions with targeted recruitment strategies accounted for 1223 (77.6%) of all minority participants enrolled. While there was a significant increase in the rate of minority accrual pre-implementation to post-implementation for the institutions with targeted recruitment (9.3% vs. 15.2%, p < 0.0001), there was no significant difference for the institutions without (3.5% vs. 3.8%, p = 0.46). Minority enrollees at the seven institutions tended to have less than a high school education, be economically disadvantaged, and were more often uninsured. These socio-demographic differences persisted at the seven institutions even after adjusting for race and ethnicity. The success of different strategies varied by institution, and no one strategy was successful across all institutions. Costs for implementation were also highly variable, ranging from $146 to $749 per minority enrollee. Limitations Data on minority recruitment processes were not consistently kept at the individual institutions. In addition, participant responses via newspaper advertisements and the efforts of minority staff hired by the institutions could not be coded on Case Report Forms. Conclusions Strategic efforts were associated with significant increases in minority enrollment. The greatest successes require that a priori goals be established based on eligible racial/ethnic proportions; the historical performance of sites in minority accrual should factor into the selection of sites; recruitment planning must begin well in advance of trial launch; and there must be endorsement by prominent representatives of the racial groups of interest.

[1]  L. Minasian,et al.  Minority recruitment to the Selenium and Vitamin E Cancer Prevention Trial (SELECT) , 2005, Clinical trials.

[2]  Garnet L Anderson,et al.  The Women's Health Initiative recruitment methods and results. , 2003, Annals of epidemiology.

[3]  D. Federman,et al.  Reviews and Notes: Ethics: Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies , 1995, Annals of Internal Medicine.

[4]  A. McAlearney,et al.  Recruitment of minority and underserved populations in the United States: the Centers for Population Health and Health Disparities experience. , 2008, Contemporary clinical trials.

[5]  Shari Bolen,et al.  Barriers to recruiting underrepresented populations to cancer clinical trials: A systematic review , 2008, Cancer.

[6]  Harlan M Krumholz,et al.  Participation in cancer clinical trials: race-, sex-, and age-based disparities. , 2004, JAMA.

[7]  D. Bruner,et al.  Reducing cancer disparities for minorities: a multidisciplinary research agenda to improve patient access to health systems, clinical trials, and effective cancer therapy. , 2006, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[8]  A. Yancey,et al.  Effective recruitment and retention of minority research participants. , 2006, Annual review of public health.

[9]  D. Federman,et al.  COMMITTEE ON THE ETHICAL AND LEGAL ISSUES RELATING TO THE INCLUSION OF WOMEN IN CLINICAL STUDIES , 1994 .

[10]  E. Bass,et al.  Knowledge and access to information on recruitment of underrepresented populations to cancer clinical trials. , 2005, Evidence report/technology assessment.

[11]  Lois Lamerato,et al.  Recruitment methods employed in the prostate, lung, colorectal, and ovarian cancer screening trial , 2009, Clinical trials.