In a stunning departure from how FDA guidances are issued by the agency, President Donald Trump said Wednesday evening that he might move to reject a guidance that is expected to impose stricter thresholds for any COVID-19 vaccine Emergency Use Authorizations (EUAs). Read More
In an update to the FDA’s guidance on conducting trials during the pandemic, the agency has reminded investigators of their responsibility to review all adverse events (AE) and report to their IRBs any potential risk to trial participants. Read More
Artificial intelligence (AI) company Opyl has launched a new AI software platform that can predict the success or failure of vaccines or antibody therapies targeting COVID-19 in clinical trials. Opyl’s AI forecasting model has examined 475 registered COVID-19 trials across the globe to help predict the drugs or devices that have the greatest chance of success. Read More
The National Institutes of Health (NIH) has awarded a $12 million grant to nonprofit research institution RTI International to support research teams across 11 U.S. states in developing programs to improve awareness of COVID-19 vaccine and treatment research among underserved minority communities. Read More
A survey of sponsors and CROs found two-thirds of respondents cited regulatory and technical obstacles to implementing remote monitoring in clinical trials, but the COVID-19 pandemic has still accelerated adoption of the practice. Read More
COVID-19 outpatient treatment and prevention trials can use a new 14-point symptom scale for assessing patient reported outcomes (PRO), according to a direct-to-final guidance the FDA released last week. Read More
Health regulators abroad have begun giving the OK for AstraZeneca to resume its phase 3 COVID-19 vaccine trial following a single unexplained patient illness, but the FDA has still not cleared the trial to start back up, with FDA Commissioner Stephen Hahn saying the agency will engage in “very significant work” with the company to unravel the safety issue. Read More
The CEOs of nine pharmaceutical companies racing to develop COVID-19 vaccines made an unprecedented pledge last week to “uphold the integrity of the scientific process” in the trials they are conducting for vaccine approval. Read More
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