Researchers
To
Report on All Clinical Trial
Results, Not Just Favorable Ones
Behind the Cancer Headlines®
The International Committee of Medical Journal Editors (ICMJE) has issued a statement 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 was published online simultaneously by all ICMJE member journals.
"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
"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 note that at present only www.clinicaltrials.gov, sponsored by the United States National Library of Medicine, meets the requirements.
"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."
SOURCE:
Journal of the American
Medical Association,