Challenges of Conducting Risk-Benefit Analysis of Early Phase Clinical Trials: Results of a National Survey of IRB Chairs.

ABSTRACT: Institutional review boards (IRBs) are charged with conducting risk-benefit analysis for early phase clinical trials that often involve high levels of uncertainty regarding a trial's potential risks and benefits. Our study used a survey of IRB chairs to explore how IRBs conduct risk-benefit analysis, the unique facets of risk-benefit analysis for early phase clinical trials and specifically for early phase neurology trials, and what facilitates high-quality risk-benefit analysis. The survey measured IRB chairs' perceived difficulty, preparedness, processes, and satisfaction with risk-benefit analysis for early phase trials. The survey was completed by 148 of the 259 eligible IRB chairs for a response rate of 64.6%. Two-thirds of respondents found risk-benefit analysis for early phase clini

SUBMITTER: Baugh CM 

PROVIDER: S-EPMC12609048 | biostudies-literature | 2025 Nov-Dec

REPOSITORIES: biostudies-literature