Update: ISCTM Brings Together FDA, EMA, & Industry for Working Group on Adapting Trials for Remote Assessment

We recently wrote about the first two special meetings of the Innovative Technologies Working Group of the International Society for CNS Clinical Trials and Methodology (ISCTM) to discuss challenges related to implementing remote assessments in CNS clinical trials in the context of COVID-19 precautions. These calls provided an open forum for discussion between FDA, industry, academia, and clinical trial sites. There has since been a third call, which also included participants from EMA sharing their views.

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Facing the Challenge: Considerations for Conducting Remote Video Assessments

With many study subjects isolating themselves at home and many sites concerned about seeing subjects in-person for routine study visits, we are seeing an increased interest in remote visits. Sponsors that consider this for their studies often choose to complete the remote visits with video conferencing tools in order to allow more interaction between sites and subjects. Even for those with experience using video in clinical trials, using it in a home-based setting brings unique challenges.

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Common Rater Errors in Pediatric Rare Disease Clinical Trials

Many rare diseases lack the well-characterized endpoints that we associate with outcome measures in more common diseases and disorders. Given that most clinical trials for rare diseases are small and often rely on assessments that are not designed specifically for the disease, it is important that every assessment is administered and scored correctly. In trials conducted in very small populations, missing, erroneous, or invalid data can have an outsized impact.

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