EU Addresses Clinical Trial Integrity Concerns In Face Of COVID-19 Crisis
Risk Assessment Of Pandemic Impact Should Be Done On Blinded Data
EU guidance offers high-level recommendations on the steps that clinical trial sponsors should take to assess the impact of COVID-19 on the quality and reliability of data being generated in ongoing studies. Early scientific advice is recommended if changes must be made to existing protocols or data analysis plans.
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A draft EU guideline explains how companies can ensure that data from ongoing clinical trials remains relevant for regulatory decision-making despite problems posed by the COVID-19 pandemic.
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