Synergy in Action

Adapting Trials (In a Hurry) for Remote Assessment: ISCTM / FDA and EMA Webinars

Public Access – In order to serve the field at large during this time of unusual and trying circumstances, the ISCTM has made the following recent webinars available to the public.

3 April – Webinar 1 – Identifying some of the key questions
17 April – Webinar 2 – FDA responses and discussion
15 May – Webinar 3 – EMA perspectives with FDA participation

Innovative Technologies Workgroup held an ad hoc call on 3 April to discuss adapting trials for remote assessment in light of the impact of COVID-19 on clinical trials and subsequent increased interest in remote assessments. The meeting was attended by visitors from the FDA Office of Medical Policy, Division of Clinical Outcome Assessments, and Division of Psychiatry who participated in the discussion.  During the course of the 3 April discussion, many questions were raised, and the FDA participants agreed to address those questions on a second call held Friday 17 April.
On Friday 15 May a third discussion was held with regulatory panelists from the EMA and EU network as well as FDA to focus on European regulatory perspectives. Differences between EU and US regulatory considerations were noted.