Stephen J.LurieMD, PhD, Senior EditorIndividualAuthorJody W.ZylkeMD, Contributing EditorIndividualAuthor
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.
Silverstein F, Simon L, Faich G. Reporting of 6-Month vs 12-Month Data in a Clinical Trial of Celecoxib—Reply. JAMA. 2001;286(19):2398-2400. doi:10.1001/jama.286.19.2398