Sponsors of drugs to treat or prevent COVID-19 should focus on populations that are the hardest-hit and least-represented in clinical trials, including minorities and the elderly, according to a new FDA guidance released last week. Read More
After Gilead Sciences’ remdesivir was approved for emergency use on COVID-19 patients, a number of other trials have gotten underway to test the antiviral’s benefits in combination with other drugs. Read More
The FBI has announced they are investigating China-affiliated cyber organizations that are attempting to steal intellectual property and public health data from U.S.-based research organizations conducting COVID-19 research. Read More
The FDA last week updated its March guidance on managing clinical trials during COVID-19 by saying that sites can conduct patient visits via video conference with some advance planning. Read More
President Trump on Friday outlined a strikingly ambitious plan to have a COVID-19 vaccine approved by the FDA and starting to be deployed by year’s end. Read More
COVID-19 has caused nearly half of all trial disruptions in the past five months, with oncology trials being hardest-hit, according to a new study out of Berlin. Read More
The severity of the COVID-19 pandemic could justify the use of human challenge studies in vaccine development, and their careful use may be worth considering if they’re conducted the right way, a medical ethics expert argued. Read More
To support research teams at sites struggling with the impact of COVID-19, the Association of Clinical Research Professionals (ACRP) has set up a Clinical Research Site Sustainability Fund to provide grants to sites for continuing education and career development resources. Read More