After an FDA career that has spanned more than three decades, former FDA Acting Commissioner Janet Woodcock — who now serves as principal deputy commissioner — still plays a significant role in guiding the agency.

Woodcock has previously advised industry on the need to restructure clinical trials, including the importance of building and supporting community-based site networks in the U.S. (CenterWatch Weekly, Feb. 1, 2021). We asked for her thoughts on the agency’s work on overhauling the clinical research enterprise.

CWW: You have spoken a lot on the need to restructure the way clinical trials are conducted. What’s the best way to do that and how might the FDA involve itself in the effort?

Woodcock: The most important thing the FDA can do is provide developers and other trialists clarity on when and how they can streamline trial conduct and reduce data collection. Of course, researchers and reviewers often desire as much information as possible from each trial. But there is a hidden cost—the trials that can’t be done and the patients who can’t be enrolled because of the burdens of the trial. So the agency has worked with stakeholders on defining the circumstances in which trial conduct can be streamlined or data collection kept to the essentials without compromising the intent of the study (CenterWatch Weekly, Dec. 12, 2022).

The FDA has also worked closely with stakeholders, including the Clinical Trials Transformation Initiative, to identify innovative trial designs, evaluate the role of decentralized clinical trials and mobile technologies, and help validate novel endpoints that can enable trials to generate reliable evidence needed to assess product safety and efficacy more efficiently. For instance, we have pioneered master protocol trial designs that can evaluate, in parallel, different drugs compared to their respective controls or to a single common control (CenterWatch Weekly, May 24, 2021).

New research paradigms are needed to break down barriers between real-world data and clinical research so evidence can be shared rapidly. For instance, more trials can incorporate data from electronic health records and adopt electronic informed consent to enroll more patients in clinical trials closer to where they live and work (CenterWatch Weekly, March 20). This can reduce commonly cited barriers to clinical trial participation, such as time commitment and lack of understanding of clinical research, and accelerate researchers’ ability to ask and answer important questions.

Additionally, the FDA is committed to increasing enrollment of diverse populations in medical product development and will continue to engage with federal partners, medical product manufacturers, medical professionals and health advocates to encourage this important goal (CenterWatch Weekly, April 3). Ensuring meaningful representation of racial and ethnic minorities in clinical trials for medical products is fundamental to the FDA’s public health mission.

CWW: The FDA has taken fire from Congress and industry on the Accelerated Approval (AA) pathway and the agency’s failure to enforce confirmatory trial requirements. How has the agency changed its thinking/approach on this pathway as a result?

Woodcock: Accelerated Approval is a vital pathway to get promising treatments to patients with serious and unmet medical needs.

The Food and Drug Omnibus Reform Act changes to the AA provisions of the Food, Drug and Cosmetic Act will help provide greater assurance at the time of a drug product’s accelerated approval that the confirmatory study will progress in a timely manner and reap high-quality, interpretable results. These changes will help support the FDA’s regulatory decision-making for drugs approved through the AA pathway and minimize the time that a product is marketed based on accelerated approval before its clinical benefit can be confirmed.

The FDA is currently implementing these new authorities by working to streamline processes and determine best next steps. We will provide updates as appropriate.