Posted by Michael Wonder on 09 Apr 2020
Global regulators stress need for robust evidence on COVID-19 treatments
9 April 2020 - International regulators have published a report today highlighting their considerations on the development of potential COVID-19 therapeutics, clinical trials and compassionate use programmes.
The report presents the outcomes of a workshop on COVID-19 therapeutic medicine development that was organised by EMA under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA).
At this point in time, no medicine has yet clearly demonstrated efficacy in treating COVID-19. Workshop participants stressed that the fastest way to serve patients was to collect robust evidence to determine which investigational agents or repurposed medicines would be safe and effective for the treatment of COVID-19. Regulators agreed that multi-centre randomised controlled studies are the best way to generate the data required to enable rapid development and approval of potential treatments for COVID-19. They also agreed on a harmonised approach to make best use of the available supply.
