Global regulators reach accord on COVID-19 therapeutics' trial endpoints

31 July 2020

International regulators have published a report today on the acceptability of various primary endpoints in the clinical trials conducted for the development of treatments for COVID-19.

The report summarizes the main outcomes of the second workshop on COVID-19 therapeutics and clinical trials organized 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 European Medicines Agency on July 20, 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 III studies.

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