COVID-19: EMA Tackles Trial Data Interpretability

Sponsors Should Assess Likelihood Of Delivering Interpretable Results

 
• By Vibha Sharma

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.

Young businessman working on a virtual screen of the future and sees the inscription: Clinical trial
EMA Will Be Pragmatic In Assessing Data From Trials Hit By Coronavirus • Source: Shutterstock

The European Medicines Agency has issued a draft guideline on the steps that companies can take to support the regulatory interpretation of data from ongoing clinical trials affected by the coronavirus pandemic.

The COVID-19 outbreak has already affected many ongoing trials and is interfering with the collection, analysis and interpretation of data....

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