Résumé :
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[BDSP. Notice produite par INIST-CNRS R0xoT2WI. Diffusion soumise à autorisation]. Context : Large clinical trials are the criterion standard for making treatment decisions, and non publication of the results of such trials can lead to bias in the literature and contribute to inappropriate medical decisions. Objectives : To determine the rate of full publication of large randomized trials presented at annual meetings of the American Society of Clinical Oncology (ASCO), quantify bias against publishing non significant results, and identify factors associated with time to publication. Design : Survey of 510 abstracts from large (sample size,>=200), phase 3, randomized controlled trials presented at ASCO meetings between 1989 and 1998. Trial results were classified as significant (P. 05 or not reported), and the type of presentation and sponsorship were identified. Subsequent full publication was identified using a search of MEDLINE and EMBASE, completed November 1,2001 ; the search was updated in November 2002, using the Cochrane Register of Controlled Trials. Authors were contacted if the searches did not find evidence of publication. Main Outcome Measures : Publication rate at 5 years ; time from presentation to full publication. Results Of 510 randomized trials, 26% were not published in full within 5 years after presentation at the meeting. Eighty-one percent of the studies with significant results had been published by this time compared with 68% of the studies with non significant results (P<. studies with oral or plenary presentation were published sooner than those not presented and pharmaceutical sponsorship cooperative group for which was specified these factors remained significant in a multivariable model. the most frequent reason cited by authors publishing lack of time funds other resources. conclusions : substantial number large phase trials at an international oncology meeting remain unpublished years after presentation. bias against non results is problem even randomized trials. publication breaks contract that investigators make trial participants funding agencies ethics boards.>
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