Lawmakers Call on NIH to Make Demographic Data Public for All Clinical Trials

Slaughter, DeLauro, and Capps Push For Greater Transparency to Ensure Women and Minority Participation in Critical Research


WASHINGTON— Today, Congresswomen Louise M. Slaughter (D-NY), Rosa DeLauro (D-CT), and Lois Capps (D-CA) led a letter with their colleagues calling on the National Institutes of Health (NIH) to make demographic information pertaining to all clinical trials public, including those performed by pharmaceutical companies.


Before 1993, research at NIH, the country’s premier federal sponsor for health research, was almost exclusively conducted on white males. Because drugs can have different effects on women and persons of color, scientists and government officials were getting a skewed picture of a drug’s effectiveness and safety. According to Scientific American, “eight out of 10 drugs pulled from the market by the Food and Drug Administration (FDA) between 1997 and 2001 posed greater health risks for women than men.” In 1993, Congress passed the groundbreaking NIH Revitalization Act to address the issue of gender and racial disparities in NIH trials by requiring women and minority participants in Phase III clinical trials.


However, a majority of clinical trials in the U.S. are conducted by pharmaceutical companies outside the jurisdiction of the NIH, and the mandate for inclusion does not apply, meaning there is no verification that women and minorities have been given equal opportunities to participate in clinical trials. Representatives Slaughter, DeLauro, and Capps called on the NIH to require that the demographic data from clinical trials performed by NIH as well as those performed by pharmaceutical companies be published on ClinicalTrials.gov.


“Ensuring that ClinicalTrials.gov is transparent and easily navigable will aid in clinical trial development and advance our scientific knowledge,” the Representatives wrote. “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.”


Read the full letter below:


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 ClinicalTrials.gov. 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 ClinicalTrials.gov 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 ClinicalTrials.gov 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.


Sincerely,


Hon. Louise M. Slaughter                                              
Hon. Rosa DeLauro
Hon. Lois Capps
Hon. Elijah Cummings
Hon. Diana DeGette
Hon. Raul Grijalva
Hon. Marcy Kaptur
Hon. Barbara Lee
Hon. Michelle Lujan Grisham
Hon. Carolyn Maloney
Hon. Doris Matsui
Hon. Betty MucCollum
Hon. Jim McDermott
Hon. Gwen Moore
Hon. Carol Shea-Porter
Hon. Mike Thompson
Hon. Paul Tonko
Hon. Henry Waxman
Hon. Judy Chu
Hon. Ami Bera
Hon. Eric Swalwell
Hon. Eleanor Holmes Norton


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