The FDA issued guidance to provide sponsors with statistical advice in order to maintain trial integrity and reduce the impact of the COVID-19 emergency on clinical trials conduct.

This new document follows the agency’s guidances on the conduct of clinical trials amid the pandemic, which has been updated several times since being issued in March.

“To help ensure that the trial will provide interpretable findings with correct statistical quantification of uncertainty, this guidance addresses statistical considerations for proposed changes to trial conduct due to the COVID-19 pandemic that may impact the analysis and interpretation of the primary or key secondary endpoints in the trial”. Morover, FDA states sponsors should “proactively plan to address the impact of COVID-19 on the ability to meet the trial objectives.”

For more details, please see the guidance document from FDA.

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

Contact Meditrial for immediate assistance in Europe or the US.