A much anticipated report published by Baylor College’s Eliminating Disparities in Clinical Trials [EDICT] project has provided a nine-step action plan for improving the policies surrounding the conduct of clinical trials. The EDICT project set out to create a series of policy proposals designed to help patient recruitment and retention in clinical trials. The four-year project is supported by an unrestricted grant from Genentech.
Among the issues the policies meant to address are minority participation, patient insurance, informed consent, and standards and accreditation.
“Although disparities in clinical trials has been discussed and debated extensively, this problem has generally been under-addressed and, as a result, has received little direct, systematic, or sustained intervention,” said Armin Weinberg, Ph.D., director of Baylor College of Medicine’s Chronic Disease Prevention and Control Research Center and EDICT’s principal investigator.
“This report is intended as a nationwide call to action and is provided as a blueprint for removing the barriers to clinical trial participation, which is a critical step to improving the health status of all Americans.” The report calls on the U.S. Food and Drug Administration to align its policies with the National Institutes of Health’s rules, mandating inclusion of “under-represented populations” in all human studies performed to bring treatments to market.
It seeks to implement policies to let medical journals help address minority representation by requiring researchers to tabulate demographic data versus subject recruitment when submitting data. The report addresses the need for more investment in institutional review board (IRB) training and states that “IRB members often lack the training needed to recognize disparities, and thus regularly approve research protocols that do not provide for inclusion of under-represented populations.”
It also calls for more government and industry collaboration within the entire clinical research arena, the need to scrutinize funding for “duplicative research,” and address the growing problems associated with insurance coverage for subjects enrolled in trials.
EDICT is a collaborative alliance between Baylor College of Medicine’s Chronic Disease Prevention and Control Research Center and the Intercultural Cancer Council.