PYA’s readiness assessment checklist for clinical trial programs was recently published in the Health Care Compliance Association’s (HCCA) Report on Medicare Compliance. Keeping with the Biden administration’s push for health equity, the Food and Drug Administration (FDA) has issued draft guidance to encourage a more diverse group of research subjects in clinical trials.
PYA Principal Deborah Biggs is quoted in the article “FDA Plan Strives to Increase Diversity in Research, Build Trust,” which is followed by the firm’s checklist. According to the article, the FDA’s draft guidance “encourages clinical-trial sponsors to have a diversity plan that’s designed to increase enrollment in research of ‘underrepresented racial and ethnic populations in the U.S.’”
Subscribers may access the article on HCCA’s COSMOS, an online platform for easy access to the latest compliance information.
Download a printable color copy of PYA’s checklist here.
If you would like additional guidance with implementing clinical trials or with any matter related to compliance, valuation, or strategy and integration, one of our executive contacts would be happy to assist. You may email them below, or call (800) 270-9629.
