FDA to address diversity in new drug and device studies

The Women’s Health Research Institute at Northwestern University applauds the recent release of a new Action Plan developed the Food in Drug Administration in response to a Congressional directive to look closer at the inclusion and analysis of demographic subgroups including women and minorities in applications for new drugs and devices.

The Action Plan to Enhance the Collection and Availability of Subgroup Data, released August 18,  includes 27 action steps that address the quality of data collection,  reporting and analysis; barriers to subgroup inclusion in clinical trials; and availability and transparency of sub group data in new drug/device applications.    Members of the WHRI Leadership Council, composed of researchers, educators and clinicians at Northwestern Medicine committed to women health and the study of sex differences will be reviewing and commenting on the plan.   In addition, several Council members will be participating in workgroups helping the National Institute of Health develop guidelines to increase the inclusion of female subjects in all basic science, translational and clinical research.