The Food and Drug Omnibus Reform Act of 2022 (FDORA), signed into law on 29 December 2022 as part of the Consolidated Appropriations Act, carried a set of clinical trial provisions that sponsors have been working through since.
Diversity action plans
FDORA requires sponsors of phase 3 or other pivotal studies of drugs and devices to submit a diversity action plan, with enrolment goals by demographic group, the rationale for those goals, and how they will be met. FDA was directed to issue guidance on the content and format.
Other provisions
- FDA authority to require post-approval studies for accelerated approvals and to expedite withdrawal if confirmatory trials are not conducted with due diligence.
- Encouragement of decentralised clinical trials and digital health technologies, with guidance to follow.
- Modernisation of FDA inspection practice, including remote regulatory assessments.
Operational impact
Enrolment planning now needs site selection that can reach the target populations, and data capture that can report progress against the plan. Our clinical project managers have added diversity plan tracking to study dashboards for several sponsors. See clinical project management.