Points to Consider on Implications of Coronavirus Disease (COVID-19) on Methodological Aspects of Ongoing Clinical Trials

On 29 June 2020 the EMA announced the availability of this guidance.

The Biostatistics Working Party (BSWP) would like to acknowledge the impact of the Coronavirus disease (COVID-19) on trial participants as well as on the resulting measures taken to address the COVID-19 pandemic on methodological aspects of ongoing trials. It is foreseeable that the COVID-19 pandemic will interfere with the conduct of many ongoing trials, not limited to just the collection, analysis and interpretation of clinical trial data.

BSWP would encourage Sponsors to take these points into consideration and to seek Scientific Advice on these matters early in the process if substantial modifications to the original protocols are considered necessary. Sponsors should also be assured that the aspects related to impact on recruitment, data collection, analysis and interpretation of results will be thoroughly reflected upon during the assessment of affected clinical trials data submitted to EMA for Marketing Authorization Application.

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