NEW YORK, Mar 08 (Reuters Health) - The nation's current system for protecting patients in clinical trials is outdated and in need of reform, a team from Duke University concludes in the March 7th issue of The Journal of the American Medical Association.

The current approach largely revolves around institutional review boards (IRBs), which are ill-equipped to accurately evaluate potentially critical information contained in adverse events reports, according to Duke's Dr. Michael A. Morse and colleagues.

IRBs typically receive individual adverse events reports from their own site and other participating sites without any explanation about how an event relates to other events previously observed.

In multiple trials of an experimental agent, each IRB may have access only to data from trials over which it has authority. And they may lack sufficient statistical or clinical expertise or access to information to assess overall safety and benefits.

IRBs are also swamped, overseeing as many as several hundred adverse events reports in a month, the team observes. Confusing terminology in the regulations that govern trials and imprecise definitions of what must be reported add to the burden.

As an example, Morse and colleagues note that the US Food and Drug Administration requires the investigator to "promptly report to the IRB all unanticipated problems involving risk to human subjects or others." On the other hand, the Department of Health and Human Services requires prompt reporting to the IRB of "any unanticipated problems involving risks to subjects or others."

The FDA regulation is confusing, they suggest, because the word "others" could refer to risk to other patients in the trial or those not in the study. Both regulations leave "unanticipated problems" undefined, which could encourage reporting of any problems, whether or not they are related to the trial.

IRBs should play three major roles in a multicenter trial, the authors suggest:

-- Review and approve a plan for monitoring the study.

-- Certify that the investigators understand the regulations governing patient safety.

-- Review data monitoring committee reports and query investigators as needed.

The authors also target others involved in the clinical trial process, recommending that regulatory agencies, for instance, come up with clearer definitions for adverse events and harmonize their reporting requirements. Sponsors should provide IRBs with aggregate safety data when it is requested.

"Ultimately, no single group can provide complete protection of patient-subjects," the team from Duke concludes. "A systematic plan is required for each trial so that appropriate input comes from each entity involved in its oversight."

The authors base their recommendations on information from a May 2000 meeting of professionals with expertise in various aspects of clinical trials. Duke Clinical Research Institute sponsored the event with donations from AstraZeneca, Boehringer Ingelheim Canada Ltd., Eli Lilly Corporation, Key Pharmaceuticals, King Pharmaceuticals Inc., Medco Research, Pfizer Central Research and Rhone-Poulenc Rorer.

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