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To the Editor: Constraints on the publication rights of clinical investigators in industry-initiated trials have been described,^1-2 but have been investigated in surveys that relied mainly on individuals' recall and attitudes and may have underestimated the extent of its occurrence. We examined directly the presence of constraints in trial protocols and subsequent publications.

Methods

For all 44 industry-initiated randomized trials that were approved in 1994-1995 by the Scientific-Ethical Committees for Copenhagen and Frederiksberg in Denmark and that resulted in publication, we compared the full trial protocols with all text in the subsequent publications (median publication year, 1999), including footnotes and acknowledgments.³ To look for changes over time as a response to new guidelines and ethical requirements, we also assessed the first 44 industry-initiated trial protocols approved in 2004 by the same committees; insufficient time had passed to assess subsequent publications.

For the 2004 protocols, committee requirements removed information that identified particular . . . [Full Text of this Article]

Peter C. Gøtzsche, MD, DrMedSci
pcg@cochrane.dk

Asbjørn Hróbjartsson, MD, PhD; Helle Krogh Johansen, MD, DrMedSci; Mette T. Haahr, BSc
Nordic Cochrane Centre
Copenhagen, Denmark

Douglas G. Altman, DSc
Centre for Statistics in Medicine
Oxford, England

An-Wen Chan, MD, DPhil
Department of Medicine
University of Toronto, Ontario

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