Research Ethics and Policy Series (REPS): "Regulatory and Ethical Perspectives on Pragmatic Trials: Lessons from Three Cases"- Mark Neuman, MD, MSc

Regulatory and Ethical Perspectives on Pragmatic Trials: Lessons from Three Cases

Mark Neuman, MD, MSc

Director, Research Partnerships, Leonard Davis Institute of Health Economics
Associate Professor, Anesthesiology and Critical Care, Perelman School of Medicine
Director, Penn Center for Perioperative Outcomes Research and Transformation (CPORT), Perelman School of Medicine | University of Pennsylvania

Mark Neuman, MD, MSc, Professor of Anesthesiology at Penn, will discuss regulatory and ethical issues raised in the process of designing, implementing, and reporting multi-center pragmatic trials, with a focus on 3 recently completed or planned studies focusing on aspects of anesthesia care for older surgical patients:

REGAIN (Regional versus General Anesthesia for Promoting Independence after Hip Fracture; NCT02507505), DROP-Benzo (De-adopting Routine Preoperative Benzodiazepines for Older Surgical Patients; NCT05436392); and My Anesthesia Choice-Hip Fracture (www.myanesthesiachoice.org; registration pending).

Key areas of discussion will include:

• Navigating clinician attitudes towards comparators and questions around equipoise
• Implementing single IRB processes
• Designing an approach to human subjects research review for a study conducted in partnership with a national private medical group working at hundreds of hospitals, surgery centers, and physician offices across multiple states

Lunch provided.
Streaming available via Zoom.