The UK is set to launch the world’s first COVID-19 challenge trial in January, the government says. Read More

AstraZeneca (AZ) has released the trial protocol for the late-stage study of its coronavirus vaccine candidate AZD1222 as its investigation into an adverse event continues. Read More

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

COVID-19 Drug Research Roundup 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