The European Commission published, on Tuesday 28 April, a new version of its guidance on the management of clinical trials during the Covid-19 pandemic, which provides for special time-limited measures.
This document aims to provide a harmonised set of recommendations to ensure the safety of trial participants throughout the EU while preserving the quality of the trial data. The guidelines also ensure that clinical trials for other treatments, in particular those for rare diseases and serious or life-threatening diseases for which no satisfactory treatment exists, are not disrupted by the current crisis.
“We are in the midst of the worst pandemic in recent memory and it is absolutely crucial that we show flexibility in our rules to maintain research on critical treatments, including chronic and rare diseases, through clinical trials”, commented Stella Kyriakides, Commissioner for Health and Food Safety.
That is why the Commission includes social distancing measures in its recommendations. It proposes to interrupt or reduce the recruitment of new trial participants, extend the duration of trials, or maximise telephone or video visits. Remote source data verification could facilitate the marketing authorisation of coronavirus and life-saving medicines. The document also suggests that priority in communication with authorities should be given to testing of Covid-19. More than 200 coronavirus clinical trials are currently registered in the European Union database (EudraCT).
The document is based on a first version published at the end of March by the European Commission's Expert Group on Clinical Trials (CTEG), supported by EMA (European Medicines Agency), the Clinical Trials Coordination and Facilitation Group (CTFG) of the Heads of Medicines Agency (HMA) and the GCP (good clinical practice) Inspectors Working Group of EMA. It is accompanied by a list of the directives given by each Member State.
See the document: https://bit.ly/2yMD8PM and the national guidelines: https://bit.ly/2zDwSu0 (Original version in French by Sophie Petitjean)