The International Committee of Medical Journal Editors (ICMJE) issued a statement today that the 11 member journals will require, as a condition of consideration for publication, registration in a public trials registry for clinical studies involving human patients.
The editorial outlining the new policy is published online simultaneously by all ICMJE member journals and was posted today on the JAMA website. It will also appear in print in the September 15 issue of JAMA.
“Honest reporting begins with revealing the existence of all clinical studies, even those that reflect unfavorably on a research sponsor’s product. Unfortunately, selective reporting of trials does occur, and it distorts the body of evidence available for clinical decision making.”
The ICMJE editors write that the trials must register at or before the onset of patient enrollment and that this policy applies to any clinical trial starting enrollment after July 1, 2005. “We speak only for ourselves, but we encourage editors of other biomedical journals to adopt similar policies.” …. “The ICMJE does not advocate one particular registry, but its member journals will require authors to register their trial in a registry that meets several criteria. The registry must be accessible to the public at no charge. It must be open to all prospective registrants and managed by a not-for-profit organization. There must be a mechanism to ensure the validity of the registration data, and the registry should be electronically searchable.” The editors list the further details they will require in a public registry in this editorial and note, that at present, only www.clinicaltrials.gov, sponsored by the United States National Library of Medicine, meets the requirements.
“Registration is only part of the means to an end; that end is full transparency with respect to performance and reporting of clinical trials.” … “Patients who volunteer to participate in clinical trials deserve to know that their contribution to improving human health will be available to inform health care decisions. The knowledge made possible by their collective altruism must be accessible to everyone. Required trial registration will advance this goal.”
In an accompanying commentary, Drummond Rennie, M.D., a deputy editor of JAMA, writes that the idea of registering clinical trials has been in existence for many years, and the need for a comprehensive tracking system for reporting results is long overdue.
“One consequence of this lack of reporting is a persistent bias in favor of positive results and therefore in favor of the newer and more expensive treatments. Another consequence is that harmful effects found in unpublished trials disappear without a trace, since the U.S. Food and Drug Administration (FDA) has no mandate to report them to the public.”
“Physicians and the public are now well aware of the importance of the registration of clinical trials,” Dr. Rennie writes. “Progress is being made, but previous experience suggests that, because of inherent conflicts of interest, it is unlikely that industry will ever be able to establish a large, common, complete, useful, trustworthy, up-to-date, and easily accessible register maintained over the long term. Experience also demonstrates the enormous costs of not knowing about trials that bury data showing lack of benefit and that hide the harms of new treatments. The financial cost of an effective, independent, and transparent clinical trial register would amount to a tiny fraction of the costs of the trials themselves, or the costs of not knowing their results, while the personal costs of allowing the present chaotic system to continue are incalculable.”