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Unwanted Results:Failure to Publish

Abstract #973

Burying of unwanted results: a survey of more than 500 large randomized clinical trials presented at ASCO meetings to determine the probability and causes of failure to publish

MK Krzyanowska, M Pintille, I Tannock

Dana-Farber Cancer Inst., Boston, MA; Princess Margaret Hospital, Toronto, ON, Canada

Purpose: Failure to publish results of clinical trials can lead to bias in the literature and inappropriate medical decisions. The aims of our study were to (1) determine the rate of subsequent publication of randomized trials presented at ASCO meetings between 1989 and 1998; (2) quantify bias against publishing negative results; and (3) generate a compendium of important unpublished trials.

Methods: Abstract books were reviewed to identify randomized trials with a sample size >200. For each trial, data were summarized for tumor type, sample size, endpoints addressed, type of analysis, participant organization(s) and pharmaceutical sponsorship.

Results of each study were classified as positive (p=approx. 0.05) or negative (p>0.05 or not reported) for the main endpoint(s). A computer-based search was used to identify subsequent publication(s). If a citation was not found, authors were contacted, and if non-publication was confirmed, reasons for not publishing were determined.

Results: The overall publication rate regardless of follow-up time was 420/540 abstracts (78%). Using Kaplan-Meier estimates the probability of publication at 3 years was 52% for positive trials and 39% for negative trials (p<0.0001). Cox proportionate hazards analysis showed that studies which were presented at plenary sessions (p=0.002), contained final versus interim results (p=0.015) and studies with positive findings (p=0.013) were more likely to be published whereas Cooperative Group studies were less likely to be published (p=0.004).

With respect to quality of abstracts, only 21% had explicitly stated the primary endpoint, 75% reported more than one endpoint and binding was used in 12%.

Conclusions: Many large randomized trials presented at ASCO meetings remain unpublished. This is in part due to bias against publishing negative results. Failure to publish the results of clinical trials breaks the agreement that investigators have made with study participants and funding agencies, and is a form of scientific misconduct.

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