COVID-19: EMA Tackles Trial Data Interpretability
Sponsors Should Assess Likelihood Of Delivering Interpretable Results
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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New EU guidance on managing clinical trials in the context of COVID-19 requires sponsors to critically assess the feasibility of starting a new clinical trial or including new participants in an ongoing trial. A separate survey indicates that patient willingness to participate in new trials has dramatically declined due to the pandemic.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Sixty-nine guidance documents have been posted on the tracker since its last update.
A UK regulator with the MHRA is concerned that bioanalytical laboratories are not being given enough time to do their job properly by drug companies under pressure to ensure their clinical trials remain on schedule.