Advancing Randomized Clinical Trials in Surgery: Role of Exception From Informed Consent, Central Institutional Review Board, and Bayesian Approaches

Advancing Randomized Clinical Trials in Surgery: Role of Exception From Informed Consent, Central Institutional Review Board, and Bayesian Approaches
Review
Amelia W. Maiga, Rebecca A. Snyder, Lillian S. Kao, Mehul V. Raval, Mayur B. Patel, Martin L. Blakely
Journal of Surgical Research, 25 April 2024
Introduction
…In order to address the unique challenges of designing and conducting randomized clinical trials in surgery, surgeon investigators from the Society of University Surgeons and the Association for Academic Surgery hosted a didactic session at the 2023 Academic Surgical Congress. In this paper, we summarize the key discussion points presented in this session and outline opportunities to promote the design of feasible and generalizable surgical RCTs. In particular, we will review the use of exception from informed consent (EFIC) in surgical trials, central institutional review board (IRB) review for multicenter trials, currently recommended statistical methods to increase clarity of trial findings and avoid dichotomy around the P value, and opportunities to incorporate Bayesian methods into study design and interpretation…