How many women are included in clinical trials? Dems want to know

Twenty-two Democratic lawmakers have asked the National Institutes of Health to publicly disclose demographic data for all clinical trials posted on ClinicalTrials.gov.

The House Democrats want to ensure that more trial data is available for women and minorities so they can understand how medical products may affect them differently. Historically women and minorities have been underrepresented in clinical trials.

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Congresswomen Louise Slaughter (D-N.Y.), Rosa DeLauro (D-Conn.), and Lois Capps (D-Cali.) spearheaded the letter and said while the NIH is mandated to include women and minorities in clinical trials, the majority of trials are conducted by the medical industry.

All drug and medical device makers who conduct mid- to end-stage clinical trials in the U.S. or want their products to be approved in the U.S. must register on ClinicalTrials.gov and post summaries of their trials. NIH manages the site.

The congresswomen say the lack of trial data on women and minorities means sometimes they are put at higher risk or they don’t realize the medical product they are using isn’t as effective for them.

“[CinicalTrials.gov] 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,” they state.

“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,” they added.

In the past certain drugs such as the heart drug Plavix has been found to be less effective and potentially more harmful to certain minorities such as Asians and Pacific Islanders.

As a result, Hawaii Attorney General David Louie recently filed a lawsuit against Bristol-Myers Squibb and Sanofi-Aventis, the manufacturer and distributor of the drug, for not being upfront with their demographic data in the past.

The Pharmaceutical Research and Manufacturers of Amercia say Food and Drug Administration regulations prevent companies from proactively communicating most demographic information that they collect to patients and physicians.

They argue the appropriate policy change would be for the FDA to allow companies to share data proactively about the clinical trials.

— This article was updated June 19 at 1 p.m.