US patient safety needs overhaul, report says

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US patient safety needs overhaul, report says

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protecting patients in clinical trials is outdated and in need of reform, a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.

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.

SOURCE: The Journal of the American Medical Association 2001;285:1201-1205.