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January 12, 2005

Clinical Trial Registration and the ICMJE

JAMA. 2005;293(2):157-158. doi:10.1001/jama.293.2.157-c

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.

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