In 2016, 31,468 patients participated in clinical trials that led to the approval of 22 new drugs by the FDA. Of these, 48% were women and 24% were non-white. While not quite matching the same percentages seen in the general population (approximately 51% women and 30% minority, according to the 2010 census), it is an improvement from 2015, when 40% of patients participating on trials for agents that gained FDA approval were women and only 21% were non-white.
Efforts to improve
The inclusion of minorities and women has been a focus of both the FDA and the NIH for over 20 years, since 1993 federal law required that they be included in clinical research (Public Law 103-43). Now there is an entire NIH office focused on women’s health (NIH Office of Research on Women’s Health) as well as an FDA Office of Women’s Health. However, it isn’t as easy as stating that women and minorities have to participate in research to get a representative sample to participate. For decades, women were seen as too fragile to participate in research. Ethical tragedies that have occurred for the past 80 years have negatively affected the participation of minorities in research. Events affecting communities such as the Willowbrook patients, the Havasupai tribe, and syphilis sufferers in Tuskegee are well documented, so I will not take the time to discuss reasons why clinical trial participation from minorities is low. Beyond these ethical issues that have caused distrust with the scientific community, other daily interruptions have affected recruitment. A 2013 survey of clinical research coordinators (CRCs) on recruitment and retention found that top barriers to recruiting research participants included time commitment issues, risk concerns, and distance and/or transportation issues. Twenty percent of CRCs indicated that race/ethnicity impacted recruitment while approximately 75% disagreed or strongly disagreed with the statement that it is easier to recruit minority subjects.
Efforts, particularly since 2010, have been made to reach out to people to gain trust, build partnerships, and increase their representation in research on diseases and conditions afflicting their communities. The Society for Women’s Health Research and the US FDA Office of Women’s Health published “Dialogues on Diversifying Clinical Trials: Successful Strategies for Engaging Women and Minorities in Clinical Trials” in 2011, which discusses the need to address disparities in health with these populations, attitudes, access, and methods to partner with and through the community to increase awareness and participation. Two FDA Commissioners (Dr. Hamburg in 2011 and Dr. Califf in 2016) have spoken on the need to increase diversity in clinical trials. Both highlight the dedication of the FDA to provide opportunities for women and minorities to participate in research as well as offices dedicated to their inclusion in research and tools for researchers to effectively meet the needs of these communities. Many tools can be found online that assist researchers in identifying, engaging, recruiting, and retaining minorities and women in research. A few, publicly available, federal resources include the 2015 NIH Outreach Toolkit on engaging, recruiting, and retaining women in clinical research, the FDA Special Topics Page on Women in Clinical Trials, and the FDA Research, Policy, and Workshops on Women in Clinical Trials page.
The need for greater progress
Although progress has been made to reach these communities, more can still be done to keep moving recruitment numbers closer to population metrics. Human subjects regulations, by which both the NIH and the FDA must adhere, still consider pregnant women a vulnerable population, a patriarchal viewpoint which alienates many women considering research. Researchers and sponsors must make consent documents and resources available to minority populations in their primary language, which may not be English. More work must be done by the scientific community to understand and incorporate cultural wishes of communities to effectively conduct needed research in areas that truly impact those community’s health. Much progress has been made over the last decade, but additional work must continue at the federal and local levels to ensure that these populations continue to be reached in meaningful and respectful ways.