The Innovative Technologies Working Group of the International Society for CNS Clinical Trials and Methodology (ISCTM) held two special meetings to discuss challenges related to implementing remote assessments in CNS clinical trials in the context of COVID-19 precautions. The need for remote assessments is clear. It is also clear that difficulties in implementation and questions about data validity are real. FDA has issued guidance on conducting trials in the context of the COVID-19 pandemic while also recognizing the need for ongoing clarification. The calls provided an open forum for discussion between FDA, industry, academia, and clinical trial sites.
During the initial call on April 3, working group members Bill Horan, VP Clinical Science at VeraSci, Corey Fowler, Associate Director, Global Clinical Development at Otsuka, and Michael Sand, Senior Clinical Program Leader at Boehringer Ingelheim, discussed challenges and offered strategies for switching from in-person assessments to remote assessments in ongoing trials. They addressed four questions:
- What have been the most difficult logistical challenges you have encountered implementing remote assessments?
- Do you have concerns about the impact of switching to remote assessments on future data analysis and interpretation?
- How are you handling the issue of participant access to technologies to enable remote assessments?
- What characteristics of a measure make it more or less suitable to be adapted for remote assessment?
FDA attendees asked clarifying questions, referred working group members to the FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic, and made some comments consistent with the guidance document. The remainder of the first call provided industry participants with an opportunity to ask questions which formed the basis for the second call. The full recording of the April 3 call is available here.
The questions were grouped into seven themes, which formed the basis for the discussion during the second call, held on April 17. During the second call, a panel of FDA representatives along with Dr. Bob Bilder, Professor Psychiatry and Behavioral Sciences at UCLA, and Dr. David Walling, CEO at Collaborative Neuroscience Research, commented on the themes and questions from the initial call. The themes addressed included:
- Data quality
- Remote assessments method validity
- Remote assessments content validity
- Remote assessment methodology
- Technology Access
The ISCTM Innovative Technologies Working Group is co-chaired by Mike Davis, FDA Division of Psychiatry Products Office of New Drugs, and Rich Keefe, CEO at VeraSci.
Do you have questions about using remote assessments for your ongoing study? VeraSci is offering sponsors a complimentary consultation to discuss options for remote assessment as well as other challenges related to the impact of COVID-19 on their studies.
Update: ISCTM held a third meeting on May 15, 2020 which incorporated EMA perspectives with FDA participation. View the recording.