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Do we need to adjudicate major clinical events?

Duke Clinical Research Institute, P.O. Box 17969, Durham, NC 27715-7969, grangool{at}mc.duke.edu

Victor Vogel

University of Pittsburgh IRB, Magee Women's Hospital, Pittsburgh, PA

Steve R Cummings

University of California, San Francisco, CA

Peter Held

AstraZeneca, Molndal, Sweden

Fred Fiedorek

BMS, Princeton, NJ

Mitzi Lawrence

PHRI, Hamilton, ON, Canada

Bruce Neal

George Institute, Camperdown, Australia

Hiedi Reidies

Boehringer Ingelheim

Leanne Santarelli

PHRI, Hamilton, ON, Canada

Rosemary Schroyer

GlaxoSmithKline, King Of Prussia, PA

Norman L Stockbridge

FDA, Washington, DC

Feng Zhao

PHRI, Hamilton, ON, Canada

Purpose The use of centralized systems to adjudicate clinical events is common in large clinical trials, in spite of relatively little published literature concerning the rationale and justification. The purpose of this manuscript is to review the reasons for central adjudication and to discuss whether trials could be simplified by limiting or streamlining the adjudication process.

Methods We reviewed the literature concerning central adjudication and documented the experience of adjudication in several clinical trials. Since definitions for nonfatal events are generally heterogeneous and subjective, one reason for a central process of adjudication is to assist in assuring systematic application of the definition used in the trial. In open-label trials, assuring that the adjudication is done blinded to treatment assignment may provide protection against differential misclassification. Regulatory authorities, including the FDA, derive confidence in the validity of results when central adjudication is performed. The clinical community has become accustomed to a certain amount of adjudication and may criticize trials that lack adjudication.

Limitations It is difficult to document the value of adjudication in trials that have reported adjudicated and nonadjudicated event rates and related treatment effects. Making rationale decisions about when and how to adjudicate is hampered by the lack of published study of when and how central adjudication is helpful to improve the quality and validity of trials and at what cost.

Conclusions Adjudication has not been shown to improve the ability to determine treatment effects. Thus, adjudication may be overly complex and overused in many large simple trials. The appropriate role of central adjudication — which trials, which outcomes, what methods — deserves scrutiny and further study. Clinical Trials 2008; 5: 56—60. http://ctj.sagepub.com

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