Posted by Michael Wonder on 31 Jul 2020
Global regulatory workshop on COVID-19 therapeutics #2: agreement on acceptable outcomes for clinical trials
31 July 2020 - International regulators have published a report today on the acceptability of various primary outcomes in the clinical trials conducted for the development of treatments for COVID-19.
The report summarises the main outcomes of the second workshop on COVID-19 therapeutics and clinical trials organised under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA). The workshop was co-chaired by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) and EMA on 20 July 2020.
Many developers of medicines for the treatment of COVID-19 have already or are in the process of conducting clinical trials and have approached their regulatory authorities with proposals for phase 3 clinical trials.
