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To the Editor: We welcome the statement by the ICMJE¹ on the need for prospective trial registration but would like to suggest the possibility of achieving full transparency of clinical trials by the publication in journals of study protocols and rationales. A prospective full description of the planned analyses may minimize post hoc analyses and thus serve the integrity of the results ultimately presented. Moreover, it is possible to describe the rationale, design, and ethical and safety issues of the study in much more detail than is required in trial registration or is possible in the final publication. Losing a "competitive edge" would be unlikely, since major clinical dilemmas under study usually need more than 1 large randomized trial before general acceptance and implementation; publishing full study protocols would be particularly suitable for multicenter trials.

Marc G. H. Besselink, MD
m.besselink@chir.azu.nl

Hein G. Gooszen, MD, PhD
Department of Surgery

Erik Buskens, MD, PhD
Julius Center for Health Sciences and Primary Care
University Medical Center Utrecht
Utrecht, the Netherlands

1. DeAngelis CD, Drazen JM, Frizelle FA, et al, International Committee of Medical Journal Editors. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. JAMA. 2004;292:1363-1364. FREE FULL TEXT

Letters Section Editor: Robert M. Golub, MD, Senior Editor.

JAMA. 2005;293:157-158.

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