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

TL;DR

This study explores how IRBs evaluate risks and benefits in early phase clinical trials, finding that these assessments are challenging and often require more support.

Contribution

The study provides new insights into the challenges IRBs face in conducting risk-benefit analysis for early phase clinical trials, particularly in neurology.

Findings

Two-thirds of IRB chairs found risk-benefit analysis for early phase trials more challenging than later phase trials.

Over two-thirds of respondents reported that standardized processes and additional resources would improve risk-benefit analysis.

One-third of respondents felt unprepared to assess scientific value and risks in early phase neurology trials.

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.

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