Dialogues on Diversifying Clinical Trials: Successful Strategies for Engaging Women and Minorities in Clinical Trials

Abstract

There is mounting scientific evidence pointing to genetic or physiologic distinctions between genders and among racial and ethnic groups that influence disease risk and severity and response to treatment. The diverse enrollment of subjects engaged in clinical trials research is, thus, critical to developing safer and more effective drugs and medical devices. However, in the United States, there are striking disparities in clinical trial participation. To address this problem, the Food and Drug Administration (FDA) Office of Women's Health and the Society for Women's Health Research (SWHR) together convened the 2-day meeting, Dialogues on Diversifying Clinical Trials. The conference was held in Washington, DC, on September 22-23, 2011, and brought together a wide range of speakers from clinical research, industry, and regulatory agencies. Here, we present the major findings discussed at this meeting about female and minority patients and physicians and their willingness to participate in clinical trials and the barriers that sponsors face in recruiting a diverse trial population. We also discuss some recommendations for improving trial diversity through new technologies and greater efficiency in trial regulation and review.

Participation of Women and Sex Analyses in Late-Phase Clinical Trials of New Molecular Entity Drugs and Biologics Approved by the FDA in 2007–2009

“…The issue was the focus of a 2011 symposium, Dialogues on Diversifying Clinical Trials, organized by the FDA Office of Women's Health and the Society for Women's Health Research (SWHR) that brought patients, patient advocacy groups, clinicians, regulators, and industry participants together for a 2-day discussion. 25 Another initiative by the FDA that would enable efficient estimation of women's participation in clinical trials and help understand adverse outcomes in women and other subgroup populations is the FDA's data standardization initiative. 26,27 Through this initiative, clinical trial data submitted to the FDA are being harmonized for consistency by adopting the standards from the Clinical Data Interchange Consortium, 28 which will enable pooling of data from several studies for efficient queries of women's participation in clinical trials and assessment of sex differences in the safety and efficacy outcomes of drug products which is a difficult task if each dataset from the clinical trials were to be analyzed separately.…”

Evaluating Acupuncture and Standard carE for pregnant women with Back pain (EASE Back): a feasibility study and pilot randomised trial

“…54,55 Methods consisted of focus groups or individual interviews (in person or by telephone) with pregnant women, midwives and physiotherapists. Given that both health-care professionals 56 and women 57 can be difficult to engage in research, the offer of choice over interview format was pragmatic rather than methodological and intended to meet the needs of participants in terms of convenience. All participants were given full information about the study ahead of deciding to participate, with the option of focus groups or individual face-to-face or telephone interviews.…”

“…Previous research has pointed to frequent difficulties in recruitment to randomised trials. 57,62 Such difficulties pose major threats to external validity, increase costs and reduce research staff productivity. [63][64][65] Such research also highlights the importance of a clear understanding among potentially eligible participants of the concept of clinical equipoise, of threats to recruitment because of patient preferences 66,67 and of tensions in the process of informed consent.…”

Involving Disparate Populations in Clinical Trials and Biobanking Protocols: Experiences from the Community Network Program Centers

“…Only approximately 3 to 5 percent of adults with cancer in the U.S. participate in such trials and historically, clinical therapeutic trial participation among NHWs far exceeds that of minority populations (15, 23). For example, Hispanics make up 16 percent of the U.S. population but only 1 percent of trial participants (24). From 2003 to 2005, African Americans made up only 8 percent of participants in Phase I-III treatment studies that were publicly funded by the National Cancer Institute.…”

“…There are a number of factors that contribute to this discrepancy, including fear and apprehension as a result of past abuses, cultural and ethnic views of Western medicine, language barriers, and lack of invitation (15, 24, 25). It is imperative that these and other factors be addressed in order to increase minority participation in clinical trials.…”