Early ‘Scattershot’ Approach To COVID-19 Therapeutic Research Generated Little Actionable Data
Executive Summary
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.
You may also be interested in...
Former US FDA Commish Califf Endorses ‘Tortoise’ Approach To Clinical Trials
The once and likely future FDA commissioner emphasized the value of randomized controlled trials, the fact that not all trials are good for people, and how decentralization and digitization are leaving people behind during a panel discussion.
Robert Califf Offers ‘A Few Words In Favor Of The Tortoise’ When Conducting Clinical Trials
The once and likely future FDA commissioner emphasizes value of randomized controlled trials, the fact that not all trials are good for people, and how decentralization and digitization are leaving people behind. Takeda exec questions if industry is being bold enough.
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.