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 clinical trials more challenging than for later phase trials. Ninety-one percent of respondents felt that their IRB did an "excellent" or "very good" job conducting risk-benefit analysis, but more than one-third of respondents did not feel "very prepared" to conduct key aspects of risk-benefit analysis. Over two-thirds of respondents reported that additional resources, like a standardized process for conducting risk-benefit analysis, would be mostly or very valuable. Our results suggest that conducting risk-benefit analysis for early phase clinical trials generally and early phase neurology trials specifically is challenging for IRBs. One-third of respondents reported that they lack preparation for assessing the scientific value of these types of trials and the risks and benefits to research participants, and a majority desire additional support.