The Food and Drug Administration (FDA) released a new action plan to increase the inclusion of women, minorities, and the elderly in clinical trials.
The action plan follows a 2013 FDA report addressing demographic subgroup participation in clinical trials. The report found that many new drug and device regulatory applications lacked sufficient data for meaningful analysis of treatment effects on patient sex, race, ethnicity, and age subgroups. This report was mandated by Section 907 of the 2012 FDA Safety and Innovation Act (FDASIA), which directed the FDA to investigate the extent to which safety and effectiveness data for demographic subgroups were included in market applications for medical products.
The new action plan, released last week, is aimed at closing the gap in healthcare disparities. The plan includes 27 action items designed to meet the 3 primary goals of increasing quality, participation, and transparency. Among the items on the list are the revision of guidance documents, conducting additional research on specific areas of public health concern related to demographic subgroups, identifying barriers to subgroup participation, and improving communication with underrepresented populations. The plan also includes a projected time frame for each action to be completed, ranging from short term (within 1 year) to long term (within 3 to 5 years).
The FDA is developing a steering committee that will oversee the implementation of the action plan and set metrics for measuring progress toward goals. The FDA has also established a website, which will be updated regularly to allow the public to track the progress of the action plan implementation.
The FDA reopened the docket for public comments on the action plan. Comments must be submitted by October 21, 2014.