More than a month after pressing the US Food and Drug Administration (FDA) to do more to promote the participation of women and minorities in clinical trials, more than a dozen members of Congress are again pressing government officials to take action on the issue, this time focusing their efforts on clinical data transparency.
In March 2014, a bipartisan group of female senators wrote to FDA, urging it to do more to ensure the equitable participation of women in clinical research.
Their letter followed the passage of the Food and Drug Administration Safety and Innovation Act (FDASIA) two years earlier. Section 907 of FDASIA required FDA to publish a report "addressing the extent to which clinical trial participation and the inclusion of safety and effectiveness data by demographic subgroups-including sex, age, race and ethnicity-is included in product applications submitted to FDA."
The thinking of regulators and legislators was that if a trial does not adequately represent patients who will ultimately use a medical product, that product may be more or less effective or safe in some of those populations.
While FDA's report would go on to state that most companies were doing a pretty good job of documenting the sex of their clinical trial participants and analyzing subgroup data, progress was far from uniform, and some industries (pharmaceutical companies) did better than others (medical device companies). Not all trials had enough participants to allow for subgroup analyses, FDA noted.
The legislators who wrote to FDA in March 2014 indicated that they hoped FDA would include new requirements for companies conducting studies, including that "representative proportions of women and minorities be included in industry-sponsored clinical trials," that industry be required to conduct subgroup analyses, and that these requirements be enforced and tracked over time.
The legislators wrote a similar letter to the Government Accountability Office (GAO) at the time, urging it to study the National Institutes of Health's (NIH) clinical trials system, with a focus on the participation of women in those trials and the factors that impact their enrollment.
New Interest, More Specific Focus
Now a different group of lawmakers from the House of Representatives is pressing the government to take action on the topic of women in clinical trials, but from a slightly different standpoint.
The legislators noted that while NIH conducts only a small proportion of clinical research in the US, it still controls ClinicalTrials.gov, the government's repository for clinical trial information.
And that, the legislators said, posed an opportunity to improve the exchange of public information.
The legislators pressed NIH to reform the site to make it easier to find information on how many women and minorities participated in clinical trials registered on the site, saying it should 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 legislators continued:
"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."
The letter was co-signed by 22 representatives.
Letter to NIH