The European Medicine Agency (EMA) released a guidance to illustrate some points to consider on implications of COVID-19 on methodological aspects of ongoing clinical trials.

“At this point in time it is not possible to provide general advice on how the different aspects related to the COVID-19 pandemic should be handled, as implications on clinical trials are expected to be manifold. Impact on recruitment, data collection, analysis and interpretation of results for each trial will need a thorough case-by-case assessment.–Safety of study participantsis paramount and must be at the heart of every decision taken, regardless of anypotential consequences for an ongoing trial. Beyond this, it is an ethical mandate to proceed with a trial that has been started so that the efforts taken by study participants and physicians can benefit drug development and inform patient care.”

For more details, please see the original document from EMA.

Meditrial can help, Contact us now

Meditrial has developed rapid workflows to conduct risk assessment, implement rescue plans and execute solutions for ongoing clinical trials:

• Identify patients requiring follow-up
• Conduct investigator and study nurse calls for training to address the situation
• Obtain authorizations for decentralized data collection
• Support to patients for alternative access to needed care
• Prepare procedures and worksheets for remote collection of patient clinical data
• Monitor work instructions and trainings for site support and remote monitoring
• EDC and ePRO solutions to enable study continuity
• Privacy protection measures