Members of the International Coalition of Medicines Regulatory Authorities (ICMRA) are working on comparing protocols of ongoing and planned COVID-19 trials with master protocols in different countries to identify potential overlaps, which may hopefully optimize research of the infection by reducing replication across trials. Read More
Although completed clinical trial visits are 37 percent below pre-COVID-19 levels, scheduled visits rose by the end of May to almost 20 percent above the COVID-19 low of late April, according to a COVID-19 Benchmark Data survey published last week by Bio-Optronics. Read More
Researchers funded by the National Institutes of Health (NIH) are evaluating drugs doctors are using to treat COVID-19 in infants, children and adolescents. Read More
Remote good clinical practice (GCP) inspections of a trial site and/or sponsor may be necessary during the COVID-19 health crisis, according to new guidance from the European Medicines Agency (EMA), but inspection teams should recognize that preparation of remote GCP inspections will be more demanding than on-site inspections as it will require early communication with the sponsor to determine whether a remote inspection is feasible. Read More
The African Academy of Sciences (AAS) is seeking to accelerate the continent’s involvement in COVID-19 trials with the launch of a Clinical Trials Community (CTC) online platform. Read More
Biopharma sponsors reported a 40 percent decrease in clinical trial starts for the first part of 2020 because of COVID-19, according to a new survey that also shows 43 percent of respondents are optimistic that their clinical trial budgets will increase in the second half of the year. Read More
The U.S. government is planning to launch phase 3 trials of three COVID-19 vaccine candidates, starting with Moderna’s as soon as next month, followed by AstraZeneca’s AZD1222 in August, and a Johnson & Johnson candidate in September. Read More
Addressing risks associated with the COVID-19 pandemic while embracing new and more accessible approaches to keep clinical trials running may have uncovered the secret to improving the pharma industry’s return on investment (ROI) in R&D. Read More