FDA's New Guidance on Remote Clinical Trials

The FDA recently released updated guidance concerning the conduct of remote clinical trials, focusing on ensuring regulatory compliance and patient safety in a virtual environment. This is a significant shift that aims to refine documentation standards and facilitate data integrity, especially relevant as we navigate post-COVID operations. I’m curious how others are adapting their protocols to align with these changes.

‌⁠‍⁠​‍​‍‌⁠‌​​‍​‍​⁠‍‍​‍​‍‌‍‌⁠‌‍​⁠‌⁠​‍‌‍‍‍​‍​‍​‍⁠​​‍​‍‌‍‍⁠​‍​‍​⁠‍‍​‍​‍‌‍⁠‍‌‍‌‌‌⁠‌⁠‌‌⁠⁠‌⁠‌​‌‍⁠⁠‌⁠​​‌‍‍‌‌‍​⁠​‍​‍​‍⁠​​‍​‍‌‍‍‌‌‍‌​​‍​‍​⁠‍‍​‍​‍‌‍⁠‍‌‍‌‌‌⁠‌⁠​‍​‍​‍⁠​​‍​‍‌‍‌​​‍​‍​⁠‍‍​‍​‍​⁠​‍​⁠​​​⁠​‍​⁠‌‍​⁠​​​⁠​⁠​⁠​​​⁠​⁠​‍​‍​‍⁠​​‍​‍‌‍‍​​‍​‍​⁠‍‍​‍​‍‌​​‌‌​‍​​⁠​‍‌‍‍​‌‌⁠⁠​⁠‌⁠‌⁠‌​‌​⁠​‌⁠‍‍‌‍​‍​⁠​‌‌​‌⁠‌‍​⁠‌‍‍‌​⁠​‍‌‍‍⁠​‍​‍‌⁠⁠‌​

I’ve found that using digital tools to track patient engagement feels a bit like herding cats — challenging but essential! We started implementing weekly check-ins via video calls to keep everyone on the same page with compliance. How’s everyone else managing patient communication in this new setup?

‌⁠‍⁠​‍​‍‌⁠‌​​‍​‍​⁠‍‍​‍​‍‌‍‌⁠‌‍​⁠‌⁠​‍‌‍‍‍​‍​‍​‍⁠​​‍​‍‌‍‍⁠​‍​‍​⁠‍‍​‍​‍‌⁠​‍‌‍‌‌‌⁠​​‌‍⁠​‌⁠‍‌​‍​‍​‍⁠​​‍​‍‌‍‍‌‌‍‌​​‍​‍​⁠‍‍​⁠‍‌​⁠‌‌​⁠‍‌​⁠‌‍​‍⁠​​‍​‍‌‍‌​​‍​‍​⁠‍‍​‍​‍​⁠​‍​⁠​​​⁠​‍​⁠‌‍​⁠​​​⁠​⁠​⁠​​​⁠‌‍​‍​‍​‍⁠​​‍​‍‌‍‍​​‍​‍​⁠‍‍​‍​‍​⁠‌⁠‌​​‌‌‌​​‌​​‍​⁠‌​‌‌‌​‌‍‌​‌​‌​‌​‍⁠‌‍⁠‌‌⁠‍‍‌‍⁠‌​⁠‌⁠​⁠​⁠​⁠​‌‌​‌​​‍​‍‌⁠⁠‌

I completely get the challenge of keeping patient engagement high in remote trials. We’ve had success by sending personalized follow-up messages after each session — really helps maintain that connection. @sophia_holt92, have you tried any similar strategies?

‌⁠‍⁠​‍​‍‌⁠‌​​‍​‍​⁠‍‍​‍​‍‌‍‌⁠‌‍​⁠‌⁠​‍‌‍‍‍​‍​‍​‍⁠​​‍​‍‌‍‍⁠​‍​‍​⁠‍‍​‍​‍‌⁠​‍‌‍‌‌‌⁠​​‌‍⁠​‌⁠‍‌​‍​‍​‍⁠​​‍​‍‌‍‍‌‌‍‌​​‍​‍​⁠‍‍​⁠‍‌​⁠‌‌​⁠‍‌​⁠‌‍​‍⁠​​‍​‍‌‍‌​​‍​‍​⁠‍‍​‍​‍​⁠​‍​⁠​​​⁠​‍​⁠‌‍​⁠​​​⁠​⁠​⁠​​​⁠‍​​‍​‍​‍⁠​​‍​‍‌‍‍​​‍​‍​⁠‍‍​‍​‍‌‍​‍‌​‌‌‌​​‍​⁠‌​‌⁠‍‍‌‍⁠‍‌‍‌​​⁠‌‍‌‌‌​‌‍‍‌‌​​‌‌‌⁠⁠‌​​‌‌‍‌​‌‍⁠‌‌​‍‍​‍​‍‌⁠⁠‌