Mandatory Trials Registry--Two Years In

The International Committee of Medical Journal Editors, made up of the editors of some of the most prestigious medical journals in the world, began to require in 2005 that anyone submitting a manuscript regarding a clinical trial should previously have registered that trial in a public registry meeting certain strict criteria for disclosure. The Editors have now issued an interim report two years later. They claim that the effort has been a marked success. Before their requirement became effective, the largest existing registry, ClinicalTrials.gov, contained 13,153 trials. A month later there were 22,714 trials listed, and this past April, the site listed over 40,000 trials. Moreover, a World Health Organization site that was not very well developed in 2005 has now been much more fully implemented, and promises to become a useful, international one-stop entry point into all trial registries. Many journals whose editors are not part of the International Committee have joined in the requirement.

In HOOKED, I recommend mandatory clinical trials registration as a very useful interim step but not as the final answer to the many problems with industry-sponsored clinical trials, and the conflicts of interest created when academic investigators are funded by the drug industry. While more needs to be done it is nonetheless encouraging that the registry step has so far been successful.

Laine C, Horton R, DeAngelis CD, et al. Clinical trials registration--looking back and moving ahead. N Engl J Med 356:2734-35, June 28, 2007.