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Call for Questions: For Regulatory Response at ISCTM Autumn 2020 Meeting

The COVID-19 pandemic has had a significant impact on the clinical development of medical products. The virtual ISCTM Autumn Conference will include a 90-minute session entitled, “Regulatory viewpoints from EMA and FDA on contemporary challenges and strategies for conducting and analyzing clinical trials in the COVID-19 era.”, Tuesday 22 September.  This session will be in the form of a moderated panel discussion, in which representatives from the EMA and FDA will provide regulatory perspectives in response to questions submitted by ISCTM membership and meeting registrants.

Link to Submit Questions

Panelists from the FDA and EMA include:
Tiffany Farchione – Director (acting), FDA Division of Psychiatry
Bernie Fischer – Deputy Director (acting), FDA Division of Psychiatry
Florence Butlen-Ducuing – Scientific Officer, EMA
Lorenzo Guizarro, Scientific Officer, EMA
Sylva Collins – Director, FDA Office of Biostatistics
Elektra Papadopoulos – Director, FDA Division of Clinical Outcome Assessments
Isaac Rodriguez-Chavez –  Officer, FDA Office of Medical Policy
Leonard Sacks – Associate Director for Clinical Trial Methodology, FDA Office of Medical Policy

Suggested topics for questions include but are not limited to:

  • the effect of changing efficacy assessments after enrollment has begun (i.e., in-person to remote)
  • the effect of changing safety assessments after enrollment has begun
  • the impact of patient safety findings related to COVID-19
  • the effect of conducting interim analyses, based on accumulating data, to inform trial modifications
  • statistical analysis considerations for analysis of datasets modified as a result of COVID-19

We acknowledge that the clinical trial landscape is continuously evolving, and we aim to make this session as current and relevant at the time of the conference.

Therefore, please submit your questions by 22 August, to allow for one month prior to the conference for review and selection of questions, and panelist preparation.

Link to Submit Questions