Europe – Points to consider on implications of Coronavirus disease (COVID-19) on methodological aspects of ongoing clinical trials

BSWP would like to acknowledge the impact of the Coronavirus disease (COVID-19) on trial
participants as well as of the resulting measures taken to address the pandemic on methodological aspects of ongoing trials. It is foreseeable that the COVID-19 pandemic will interfere with the conduct of many ongoing trials, also with the collection, analysis and the interpretation of clinical trial data.

Most importantly, patient safety is paramount and at the heart of every decision taken, regardless of any potential consequences for an ongoing trial. Beyond this, it is an ethical mandate to proceed with a trial that has been started as long as there is an opportunity that the efforts taken by patients and physicians can benefit drug development and patient care. Although it might be desirable from a methodological point of view to continue trials or, in some cases, pause them temporarily, Sponsors are strongly recommended to integrate all available knowledge from the ethical, the medical, and the methodological perspective into decision making about the future conduct of a trial while carefully considering advice from regulatory and healthcare authorities responsible for patient and employee safety. Reference is made to other guidance related to the COVID-19 pandemic, including (Guidance to sponsors on how to manage clinical trials during the COVID-19 pandemic (EMA/141885/2020))…