‘Elites’ Need To Understand Clinical Development Remains Necessary For Drug Discovery, Woodcock Says
US FDA’s principal deputy commissioner continues to preach clinical trial reform, saying stakeholders must remember that understanding a molecule does not equate to understanding its impact on the body.
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Access to expedited regulatory pathways, marketing exclusivity and tax credits in exchange for enrolling and retaining diverse clinical trial populations could provide a ‘carrot’ to the ‘stick’ in US FDA guidance and legislative proposals; attorneys Sarah Thompson Schick and Winston Kirton also call for a re-examination of concerns about remuneration for trial participants.
FDA Commissioner’s recent Twitter threads highlight the challenges of discussing the unknowns of therapeutic interventions – and raise questions about why FDA isn’t doing more to close the information gaps.
The idea seems to stem from thinking that human interaction is the best way to combat rumors and false statements.