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Home » Topics » COVID-19

COVID-19
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T Cells Could Play Crucial Role in COVID-19 Vaccine and Treatment Trials, Experts Say

October 5, 2020
Leslie Ramsey
The first wave of COVID-19 vaccine development has not monitored the response of T cells to the virus, a missed opportunity that should be addressed in the next wave of COVID-19 research, two experts said last week. Read More

UK to Launch First COVID-19 Vaccine Challenge Studies on Healthy Volunteers

September 28, 2020
The UK is set to launch the world’s first COVID-19 challenge trial in January, the government says. Read More

AstraZeneca Unveils COVID-19 Vaccine Candidate Trial Protocol

September 28, 2020
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

Trump Says White House Could Reject Stricter COVID-19 Vaccine Requirements

September 28, 2020
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

All AE Reports Require Investigator Review, FDA Guidance Stresses

September 28, 2020
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 Update

September 28, 2020
COVID-19 Drug Research Roundup Read More

Opyl Unveils AI Platform That Predicts Drug, Vaccine Success in Clinical Trials

September 21, 2020
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

NIH Awards $12M to RTI International to Improve Inclusion of Underserved Populations in COVID-19 Trials

September 21, 2020
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

Survey Cites Regulatory, Technical Obstacles to Remote Monitoring of Clinical Trials

September 21, 2020
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

FDA Guidance Offers Recommendations for PRO Assessments in COVID-19 Trials

September 21, 2020
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
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