EMA Guidance Calls for Systematic Planning of Trial Alterations
Sponsors of clinical trials in the EU should create a systematic plan for their COVID-19 response that documents reasons for protocol deviations and other trial adjustments, according to a new draft guidance from the EMA.
Pre-planning for and identifying potential trial disruptions will help separate pandemic-related trial data from those that have not been affected by changes, the agency says. Data collection should continue as long as possible unless participant health or safety is at risk.
The guideline also recommends using an independent Data Monitoring Committee (DMC) — usually used to confirm the likelihood of trial success — to assess the likelihood of the affected trial delivering interpretable results. DMCs also can provide support for restarting normal trial operations after the crisis has passed.
Comments on the draft must be submitted to EMA by April 25.
Read the draft guidance here: https://bit.ly/2JhBY0w.