EMA GCP IWG Points to Consider Regarding the Management of Ongoing Clinical Trials Impacted by Political Conflicts, Natural Disasters or Other Major Disruptions

5 April 2023 – the EMA published GCP IWG points to consider regarding the management of ongoing clinical trials impacted by disruptions in society.

This points to consider document draws from the experience of past major disruptions in society, including the Covid-19 pandemic and the most recent developments of the Russo-Ukrainian War. These are varied in nature but may have similar, multiple consequences on clinical trials performed in the affected geographical areas. This document aims to help sponsors address the resulting challenges and mitigate risks to the rights, safety, dignity, and well-being of trial participants — a particularly vulnerable population — and to the scientific value of the clinical trials.

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