EMA Guidance on Management of Clinical Trials during COVID-19 Pandemic
Veristat has published an interesting overview of the EMA guidance:
Summary of Key Considerations Outlined in the Third Edition of the EMA Guidance
“The European Medicines Agency (EMA) has now published its third version of the Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) Pandemic. This guidance addresses the need for sponsors to change the execution of clinical trials during the global COVID-19 pandemic response.
The EMA recommends taking a risk-based approach for trials that remain active during the COVID-19 outbreak. While safety reporting requirements remain the same, the methods for capturing data will need to evolve.
Below is a summary of key points that EMA recommends considering for COVID-19 and non-COVID-19 trials at present:
The EMA suggests that sponsors and clinical trial sites need to agree on when starting new trials or determining how to continue or halt ongoing trials.”
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