SCOPE Summit for Clinical Ops Executives
Panel Real World Evidence track
Regulatory Initiatives to Enable Pragmatic Trials
Tue, Feb 4, 2025 · 11:05–11:50 AM EST Rosen Shingle Creek
About this session
Panel Discussion.
This panel will delve into regulatory initiatives that have been launched in pragmatic trials, including demonstration projects announced by the new CDER center C3TI, the crowdsourcing effort by FDA, and recent efforts within the EU, including the position paper by EFPIA on pragmatic trials and the recent ACT-EU meeting. The panel will also discuss how to reduce hurdles that drug developers may encounter while designing pragmatic trials.
