Welcome

September 2015

Dear Clinical Researcher:

In 1993, medical science took a huge leap forward when Federal law first required that women be included in NIH-supported clinical research. This pivotal legislation, a section within the 1993 NIH Revitalization Act, codified in policy the notion that females are not merely a variation of males and that all people have unique health needs.

In 2015, roughly half of NIH-funded clinical trial participants are women, and we have seen impressive gains in the proportion of people from underrepresented groups in clinical studies. Yet, looking beyond the aggregate data, we do see gaps in research participation across gender, race, and ethnicity and more still at the intersection of these three human characteristics that define people to a similar extent as biological descriptors. If we intend clinical research to address public health issues, we need to include the populations affected by the diseases under study. In short, we need to meet people where they are.

To do this, we need to be creative and savvy in addressing barriers to participation at the person level (e.g., gender affects our family and work obligations), at the systems level (e.g., the likelihood of being asked to participate in a clinical trial depends on where we receive medical care), and where multiple factors interact to influence participation. This electronic resource provides a wealth of tools, stories, and strategies that clinical researchers have deemed successful in conducting high-quality, respectful research studies with varied populations. Importantly, this resource goes well beyond a listing of policies and regulations, although these are included for reference purposes. Herein, you will find practical information: successful practices for engaging people in clinical studies, guidelines on conducting outreach with communities, and—among the most exciting content—a series of case studies that demonstrate real-life clinical research scenarios and provide suggested actions to meet the needs of both researchers and research participants.

Clinical research is one of the most important examples of the vitality of trust in biomedical research. What we learn from federally funded clinical research is the dividend of the public’s investment in science. Our results must be relevant—and thus tested rigorously—for the benefit of the public.

Sincerely,

Janine Austin Clayton, M.D.
NIH Associate Director for Research on Women’s Health