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Letter to Dr. Francis Collins, Director of the National Institutes of Health - Make Demographic Data Public for All Clinical Trials

June 17, 2014

Dr. Francis Collins

Director, National Institutes of Health

9000 Rockville Pike
Bethesda, MD 20892

Dear Dr. Collins:

Over twenty years ago, it came to the attention of Congress that the vast majority of research at the National Institutes of Health was being done with white male subjects. This exclusion of women and minorities translated into severe health disparities and an unacceptable lack of progress toward the treatment and prevention of diseases like breast and ovarian cancer or sickle cell anemia.

Historically, biomedical scientists and researchers have preferred studying male subjects for a variety of reasons, yet the 2001 Institute of Medicine Report, Exploring the Biological Contributions to Human Health: Does Sex Matter? confirmed that "every cell has a sex" and that sex matters "from womb to tomb." To address gender and racial/ethnic inequity in research, Congress passed the National Institutes of Health (NIH) Revitalization Act of 1993, mandating that women and minorities be included in all NIH-funded clinical trials in a manner sufficient to elicit information about individuals of both sexes/genders and diverse racial and ethnic groups and, particularly in NIH-defined Phase III clinical trials, to examine differential effects on such groups.

NIH's mandate to include women and minorities in numbers to allow for sufficient analysis, while important, only impacts a small percentage of human subject trials. The majority of clinical research in the United States (US) is conducted outside of the scope of NIH and is exempt from the Congressional mandate. This has made determining the true extent to which women and minorities are being included in clinical research impossible to estimate, which continues to put their health at risk.

However, all clinical research involving human subjects in the US is required to be registered on The site serves as the nation's primary resource for information on publicly and privately supported clinical trials for patients, the medical community, researchers, and the public. As such, the website should be reflective of the inclusion of women and minorities in clinical research and be navigable and user friendly so that the public can find information not only on rates of inclusion, but also results analyzed by sex in trials over all disease areas.

The current system provides demographic data for select completed trials; however, it does not allow for all studies to be analyzed by sex or other demographic data, making the examination of the extent of women and minority participation and retention in ongoing clinical trials difficult to monitor. Additionally, completed studies should report biological sex differences that have been observed in analysis, and this data should be included on the website. Further, if only one sex is examined, a justification of why both sexes were not included should be found in the description of the study. This information will aid in designing future studies to address gaps in the research, and be beneficial to both patients and the medical community at large.

Ensuring that is transparent and easily navigable will aid in clinical trial development and advance our scientific knowledge. We respectfully request a response regarding NIH's commitment to providing the data necessary to allow researchers to query all studies on by sex and demographic data in order to advance the health of all citizens and address continuing issues with the participation of women and minorities in clinical trials.


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