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Monitoring and ensuring safety during clinical research
M A Morse1, R M Califf, J Sugarman
1Center for the Study of Medical Ethics and Humanities, Box 3040, Duke University Medical Center, Durham, NC 27710, USA.
Abstract:
Increased numbers of clinical trials, many of which are large, multicenter, and sometimes international, and the marked shift of funding for clinical trials to industry have made apparent the inadequacy of mechanisms for protecting human subjects that were developed when clinical research was generally carried out on a small scale at single institutions. To address concerns regarding the protection of human subjects, a group of professionals with expertise in various aspects of clinical trials was assembled in May 2000. Participants described and evaluated the mechanisms by which clinical trials are monitored, focusing on adverse event reporting and the processes by which various parties with oversight responsibilities interact in the course of these trials. In this article, we describe the manner in which adverse event reporting might function to enhance safety and the role of data monitoring committees in using aggregate data from these reports, outline the problems that now exist for institutional review boards as they are faced with multiple adverse event reports from clinical trials while conducting continuing review, and offer recommendations for improving the current approach.
Insights
Current clinical trial oversight mechanisms are inadequate for large, industry-funded studies. This review examines adverse event reporting and data monitoring committees to improve human subject protection and institutional review board processes.
Area of Science:
- Clinical Research
- Human Subject Protection
- Regulatory Science
Background:
- Clinical trial oversight mechanisms are outdated for large, multicenter, and industry-funded research.
- Existing systems struggle to adequately protect human subjects in modern clinical research settings.
Purpose of the Study:
- To evaluate current clinical trial monitoring mechanisms, focusing on adverse event reporting.
- To identify challenges faced by institutional review boards (IRBs) in managing adverse event reports.
- To propose recommendations for enhancing human subject protection in clinical trials.
Main Methods:
- Convened a group of clinical trial professionals in May 2000.
- Evaluated adverse event reporting processes and interactions among oversight bodies.
- Analyzed the role of data monitoring committees in utilizing aggregate adverse event data.
Main Results:
- Adverse event reporting can enhance participant safety.
- Data monitoring committees play a crucial role in analyzing aggregated safety data.
- IRBs face significant challenges with multiple adverse event reports during continuing review.
Conclusions:
- Current adverse event reporting and oversight processes require significant improvement.
- Recommendations are offered to enhance the effectiveness of institutional review boards and data monitoring committees.
- Strengthening these mechanisms is essential for robust human subject protection in contemporary clinical trials.
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