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November 21, 2001

Reporting of 6-Month vs 12-Month Data in a Clinical Trial of Celecoxib—Reply

Author Affiliations

Stephen J.LurieMD, PhD, Senior EditorIndividualAuthorJody W.ZylkeMD, Contributing EditorIndividualAuthor

JAMA. 2001;286(19):2398-2400. doi:10.1001/jama.286.19.2398

In Reply: Three committees of outside investigator-consultants were established to evaluate each possible GI complication, to ensure patient safety and ethical conduct, and to provide overall direction for the CLASS study. Every suspected GI complication was individually and carefully reviewed in a blinded fashion by committee members consisting of experienced gastroenterologists. The CLASS data were carefully reviewed by the members of each of the oversight committees who had full access to the 6-month data, the longer-term data, and the analyses of these data. All of these committee members agreed that the data we submitted to JAMA were valid, the analyses appropriate, and the results clinically interpretable.

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