EMA updates guidance on coronavirus (COVID-19) implications for clinical trials

EMA updates guidance on coronavirus (COVID-19) implications for clinical trials

The European Medicines Agency has published updated guidance on the implications of the coronavirus (COVID-19) disease on methodological aspects of ongoing clinical trials following a four-week public consultation between 25 March and 25 April 2020​. The guidance was adopted by the Committee for Human Medicinal Products​ (CHMP) on 26 June 2020. It is believed that ‘the COVID-19 pandemic will interfere with the conduct of many ongoing trials, not limited to the collection, analysis and interpretation of clinical trial data’ however, the Biostatistics Working Party emphasised that ‘it is an ethical mandate to proceed with a trial that has been started so that the efforts taken by study participants and physicians can benefit drug development and inform patient care’. Sponsors have been advised to ‘integrate all available knowledge from the ethical, medical, and methodological perspective into decision making about the future conduct of a trial while carefully considering advice from regulatory and healthcare authorities responsible for study participant and employee safety’.

The guidance can be read in full here.

Source: Implications of coronavirus disease (COVID-19) on methodological aspects of ongoing clinical trials

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