Expanded Access With COVID Therapeutics Were ‘Worst-Case Scenario’ For Informed Consent
High-profile programs, such as convalescent plasma, also created public confusion about role of preapproval access and highlighted the importance of prospectively planning for reliable data collection, experts said at the DIA global annual meeting.
You may also be interested in...
US FDA and NIH leaders cite lack of early clinical trial coordination as a weakness in the pandemic response that led to use of compounds that were potentially harmful and, even today, still not proven to be effective.
Since the WHO’s pandemic declaration, the agency has granted 10 EUAs for therapeutics and three for vaccines, all of which were reviewed in less than 90 days; EUA requests from government entities boast two of the three fastest review times but were revoked or limited in the face of emerging evidence.
Given concerns about completing Phase III trials, advisory committee member asks whether US FDA has considered ‘the possibility of an expanded access protocol,’ but agency official points to added complexity that comes with the pathway; bioethics experts talk to the Pink Sheet about pros and cons of expanded access vs. EUA pathways.