COVID-19: EUCOPE Calls for more Regulatory Flexibility

Following the recent EMA guidance on clinical trials management during COVID-19, EUCOPE calls the EMA and all national authorities to allow for flexibility in these exceptional times. In addition, EUCOPE recommends the following:

• Standardised Approaches:  all stakeholders involved in discussing the COVID-19 response make best efforts to align across Member States as much as possible and to be as pragmatic as possible; European-wide approaches are necessary to ensure there is no increased risk of breaking the integrity of the trial and the data it generates.
• Regulatory Flexibility: Consistent with the spirit of providing the maximum level of regulatory flexibility in the clinical trial guidance, flexibility in adjusted timelines for satisfying regulatory requirements in relation to clinical trials.
• Statistical Issues: Inevitably study participants will not be able to attend clinical sites for follow-up visits, leading to missed data points delayed readouts or missing data. This will lead to necessary changes to statistical plans.
• Global Collaboration and Alignment: Global regulatory authorities should leverage and expand existing regulatory collaboration mechanisms to ensure the safety and rights of participants are not compromised and the integrity of the data from the trial is maintained.
• Innovative Clinical Trial Strategies: Since participant travel to clinical trial sites will be limited during the COVID-19 crisis, EU regulators should encourage innovative approaches to evaluate new medical products, such as through master protocols, adaptive studies, and decentralized trial designs.