WomenHeart, the National Coalition for Women with Heart Disease, is calling on FDA to develop strategies to ensure appropriate representation of women in clinical research.
Commenting at a public hearing on a proposed rule on an agency plan for the collection, analysis, and availability of demographic subgroup data in applications for approval of regulated medical products, WomenHeart said the extent of differences between men and women in the safety and effectiveness of drugs, biologics, and medical devices has not been studied.
“For more than 30 years, FDA has debated, considered, studied, and reported on this problem,” the group said, “yet the problem has not been fixed.” It urged FDA to commit to the following:
In other comments at the hearing, the National Center for Health Research (NCHR) said that more work needs to be done to adequately address the need for greater diversity in clinical trials. “To be successful at persuading companies to conduct safety and efficacy studies relevant to the major subpopulations that will use their products, FDA must be prepared to consistently demonstrate that they believe those data are essential for proving safety and efficacy,” the group said.
“Currently, the main challenge in conducting subgroup analyses is that the sample sizes are too small and get miniscule when age, race, and sex are all considered,” the NCHR said. “We understand that not every ethnic group or age group can be separately analyzed. However, we disagree with the assumption that it is not feasible to power studies to detect subgroup differences. It can be done, and should be done. If FDA required this practice and held companies accountable, companies will find a way to achieve this.”
Jim Dickinson is MD+DI's contributing editor.
[image courtesy of AMBRO/FREEDIGITALPHOTOS.NET]