Posted by Michael Wonder on 15 May 2020
International coordination needed to encourage conduct of large, decision-relevant COVID-19 clinical trials
15 May 2020 - Regulators are highlighting the need for a comprehensive international coordination mechanism to allow the conduct of adequately powered, randomised controlled trials, which can generate sound evidence on the effects of therapeutics or vaccines against COVID-19.
This follows a call made by EMA’s Human Medicines Committee (CHMP) for the research community to pool resources into large, well-designed, multi-arm clinical trials to determine which investigational or repurposed medicines would be safe and effective for the treatment or prevention of COVID-19.
Although the scientific community has responded to the COVID-19 challenge in an unprecedented manner, there are concerns about the growing number of COVID-19 stand-alone clinical trials with a small number of participants and observational studies, which might not generate the data required for regulatory decision-making.
