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
Besselink MGH, Gooszen HG, Buskens E. Clinical Trial Registration and the ICMJE. JAMA. 2005;293(2):157-158. doi:10.1001/jama.293.2.157-c