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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 The New England Journal of Medicine (New Engl J Med or NEJM) is an English-language peer-reviewed medical journal published by the Massachusetts Medical Society. It is one of the most popular and widely-read peer-reviewed general medical journals in the world. , JAMA JAMA
abbr.
Journal of the American Medical Association
 (Journal of the American Medical Association JAMA: The Journal of the American Medical Association is an international peer-reviewed general medical journal, published 48 times per year by the American Medical Association. JAMA is the most widely circulated medical journal in the world. ), The Lancet lancet /lan·cet/ (lan´set) a small, pointed, two-edged surgical knife.

lan·cet
n.
, Annals of Internal Medicine Annals of Internal Medicine (Ann Intern Med) is an academic medical journal published by the American College of Physicians (ACP). It publishes research articles and reviews in the area of internal medicine. Its current editor is Harold C. Sox. , 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 quotation marks
Noun, pl

the punctuation marks used to begin and end a quotation, either `` and '' or ` and '

quotation marks nplcomillas fpl

).
COPYRIGHT 2005 John S. James
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Copyright 2005, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Author:James, John S.
Publication:AIDS Treatment News
Date:Jun 24, 2005
Words:288
Previous Article:"Medical journals are an extension of the marketing arm of pharmaceutical companies".
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