WASHINGTON, Oct. 18 (UPI) -- PLoS Clinical Trials, a new online journal, will be launched next spring to report results of all randomized controlled clinical trials on humans in all medical and public-health disciplines, its sponsor said Monday.
The Public Library of Science in San Francisco said the only requirements for publication will 1) that the trial was conducted according to the Helsinki guidelines on human research, 2) it is classified by an internationally accepted registry -- such as the International Standard Randomized Controlled Trial Number or ClinicalTrials.gov -- and 3) it is reported accurately according to CONSORT criteria.
PLoS will charge a publication fee to authors to offset the journal's costs, but the fee will be waived for authors with insufficient funds, the library said in a statement.
Each submitted trial will undergo peer review by a statistician and a clinical researcher in the appropriate specialty, the statement said. The journal will publish a summary of the reviewers' comments along with each article, and readers also will be able to comment on articles at a special section of the PLoS Web site.
Dr. Harold Varmus, former director of the National Institutes of Health, and currently president of the Memorial Sloan-Kettering Cancer Institute and chairman of the board of PLoS, said the purpose of the journal was to make as much research information available as soon as possible.
"The important thing is getting the results of the studies out, so the scientific community can review them," Varmus told United Press International. "Knowing that a drug that has been approved for one use is not effective in a different situation may keep another group of researchers from wasting resources and reinventing the wheel."
Dr. Catherine DeAngelis, editor-in-chief of the Journal of the American Medical Association, said the entire scientific community is concerned about getting research information into the public domain.
"I think the idea of getting things out there is fine," DeAngelis told UPI, "but I'd like to see the (journal's) business plan. I think they will find this is a more expensive proposition than they thought."
She also said she is concerned each PLoS Clinical Trials manuscript will be seen by only one specialty reviewer before publication.
"Print journals have a minimum of three specialty reviewers, and sometimes more if we have conflicting opinions," DeAngelis said. "We consider ourselves educators. By providing good peer review, we can tell scientists what to do to make their work better."
In an attempt to bring more work to light, the recently formed International Committee of Medical Journal Editors -- including the heads of JAMA, the New England Journal of Medicine, Annals of Internal Medicine, The Lancet, the British Medical Journal and the national medical journals of Canada, Australia, New Zealand, The Netherlands, Croatia, Norway, and Finland -- agreed their journals would publish the results of studies that had joined an international registry by a certain date, and thereby attracted thousands of previously unknown research projects.
De Angelis said JAMA also has adopted a modified-access plan that provides its articles free of charge to non-subscribers six months after publication.
Global Trial Bank, a non-profit subsidiary of the American Medical Informatics Association, will collaborate with the PLoS on data storage. After a trial is published in PLoS Clinical Trials, the results will be coded and entered into the GTB database for open-access searching, browsing and data-mining, and reciprocal links will be created between the two entities. Each published trial also will be linked to a site on the international registry chosen by its investigators.
The PLoS currently publishes journals in medicine, biology, computational biology, genetics and pathogens. All research articles are accompanied by a synopsis for the lay audience, and medical articles are paired with patient summaries.
The information in PLoS Clinical Trials, like the information in all PLoS online journals, will be available for downloading and redistribution as long as authors and original sources are acknowledged, as required by the Creative Commons Attribution License.
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Astara March covers healthcare research matters for UPI. E-mail: [email protected]
