F07 - Ethical Issues in Complex Trial Design

Friday, November 19, 2021

1:30 PM – 2:30 PM ET

Location: Livestreamed

Complex clinical trial designs (e.g., 'adaptive' designs that modify key features of studies mid-stream, 'platform' or 'umbrella' designs that test multiple therapies on multiple populations, human challenge studies, etc.) promise greater efficiency, but carry distinctive ethical and practical concerns, and can be challenging for IRBs to review. This session will give IRB members and human research professionals the tools needed to identify and distinguish different types of complex study designs, identify the distinctive ethical and regulatory challenges they raise, and effectively navigate those challenges.

Learning Objectives:

Provide a clear taxonomy of clinical trial designs so IRB members can effectively identify and distinguish complex designs, based on their key features
Review the most important distinctive ethical and practical challenges these study designs raise for IRB review
Share actionable recommendations for how IRBs can navigate these challenges in ways that satisfy regulatory and ethical obligations and effectively protect participants

Speaker(s)

Marianne Kearney Chase

MGH
Boston, MA
Luke Gelinas, PhD

Advarra
The Mult-Regional Clinical Trials Center of Brigham & Women's Hospital and Harvard Medical School
Dartmouth, MA

Resource Person(s)

Jerry A. Menikoff, MD, JD

Office for Human Research Protections
Rockville, MD