Major medical journals will require that randomized trials be registered.Anyone conducting medical research on humans is already required to register most major trials in public databases, under international standards and the laws of many countries. But this requirement has often been ignored or evaded by companies that do not want to let competitors know what they are doing. In May 2005 the New England Journal of Medicine, JAMA (Journal of the American Medical Association), The Lancet, Annals of Internal Medicine, and other journals, have announced that for trials that start recruiting after July 1, 2005 (or a September 13 for ongoing trials), they "will consider a trial for publication only if it has been registered before enrollment of the first patient." This applies to "any research project that prospectively assigns human subjects to intervention and comparison groups to study the cause-and-effect relationship between a medical intervention and a health outcome"--so it would not apply to most phase I trials (which could still be registered voluntarily). Registration must include at least the 20 fields specified by the World Health Organization (the fields are named in the May 2005 statement, referenced below). And the journals will review the contents of the fields; meaningless phrases like "investigational drug" will not be accepted for the name of the intervention being studied. "The purpose of a clinical trials registry is to promote the public good by ensuring that everyone can find key information about every, clinical trial whose principal aim is to shape medical decision-making. ... Every trial participant and every investigator should be asking, 'Is this clinical trial fully registered?'" Reference: "Is this clinical trial fully registered?" You can find it in many medical journals and elsewhere by doing a Google or other search on the title (include the quotation marks). |
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