Harold Varmus says, "Members of the public participate in clinical trials, believing the results will increase knowledge. However, results are often hard to find or worse still, are not reported at all because journals tend to be interested in positive outcomes. PLoS Clinical Trials solves this by providing a freely accessible online forum where all trials can be reported, irrespective of outcome."
The journal's commitment to a transparent trials reporting system will be achieved through the acceptance and publication of all randomized trials that are ethically and scientifically sound, registered, and reported accurately. By considering all such trials for publication irrespective of the outcome of the results, the journal aims to increase the accuracy and completeness of the evidence available for clinical decision-making by practitioners, policy makers, and patients. All trials considered for publication are rigorously peer-reviewed by expert statisticians and clinicians.
As an online journal, PLoS Clinical Trials takes advantage of the unlimited space and interactivity the web provides. Each published trial is linked to its corresponding entry in a public registry and supplementary data, such as original trial protocols, are linked to each report enabling readers to evaluate the trial more thoroughly. A short commentary on each paper summarizes for a general audience how the trial results add to the evidence.
Open access means that the full contents of PLoS Clinical Trials are available to anyone to read and re-use for free, not only to researchers and practitioners but also to patients and trial participants. "The results of clinical trials belong in the public domain", says Steve Nissen, The Cleveland Clinic (Ohio, USA) and a member of the international Editorial Board of PLoS Clinical Trials. "I applaud the commitment of PLoS Clinical Trials to provide open access to randomized clinical trial reports so that investigators throughout the world can freely examine the results of these studies."
PLoS Clinical Trials has timed its launch to commemorate International Clinical Trials' Day (http://www.ecrin.org/ecrin_files/dokumente/International_clinical_trials_day_2006.pdf), with events taking place today in Brussels. PLoS Clinical Trials shares the goal with International Clinical Trials' Day of increasing clinical trials' awareness which ultimately leads to improved clinical practice.
The launch of PLoS Clinical Trials coincides with experts and funders of research worldwide proposing measures to ensure that the results of publicly-funded research, including clinical trials, are placed into the public domain. Current proposed US legislation mandates public access to federally-funded research no later than six months after publication. The Association of American Medical Colleges (http://www.aamc.org/) has presented principles for the responsible conduct and reporting of clinical trials, including the recommendation that positive, negative and null study findings always be published, preferably in peer-reviewed journals. The principles are presented in an essay in PLoS Clinical Trials by David Korn and Susan Ehringhaus (contact 1) :
Citation: Korn D, Ehringhaus S (2006). Principles for strengthening the integrity of clinical research. PLoS Clin Trials 1(1): e1.
READ THE PREVIEW OF THE FULL ARTICLE AT: http://www.plosclinicaltrials.org
PLEASE ADD THE LINK TO THE PUBLISHED ARTICLE IN ONLINE VERSIONS OF YOUR REPORT: http://dx.doi.org/10.1371/journal.pctr.0010001
The launch collection also contains articles on the following topics: the effect of interleukin-2 therapy in HIV infection; a candidate malaria vaccine's effect on parasite selection; a study on nutrient supplementation and the risk of cardiovascular disease; and a trial evaluating artemisinin combination therapies for treatment of malaria in Uganda.
Two further articles from the launch are highlighted below.
Anton JM de Craen (contact 2) and colleagues performed a randomized trial in 85-year old participants in the Netherlands. The investigators sought to determine whether the provision of unsolicited care in this population resulted in a reduction in disability over time and found that participants receiving unsolicited occupational therapy did not experience any reduction in disability compared to participants receiving standard care. The authors say: "trials in such elderly populations are rare…" and "we submitted our study to PLoS Clinical Trials knowing it will receive broader exposure than in a specialty journal and because it is open-access":
Citation: de Craen AJM, Gussekloo J, Blauw GJ, Willems CG, Westendorp RGJ (2006) Randomised controlled trial of unsolicited occupational therapy in community-dwelling elderly people: The LOTIS trial. PLoS Clin Trials 1(1): e2.
READ THE PREVIEW OF THE FULL ARTICLE AT: http://www.plosclinicaltrials.org
PLEASE ADD THE LINK TO THE PUBLISHED ARTICLE IN ONLINE VERSIONS OF YOUR REPORT: http://dx.doi.org/10.1371/journal.pctr.0010002
Richard Smith and Ian Roberts (contact 3) take a controversial look at the long-term future of trial reporting. In a provocative guest editorial they argue that a new system is needed for the dissemination of clinical trial results and propose that protocols be deposited and peer-reviewed on the web and data placed in the public domain for pre-specified analysis and comment. This system would replace journal publication of trial results and provide universal access to clinical trial data as a safeguard against bias, preventing the manipulation of trial evidence.
Citation: Smith R, Roberts I (2006) Patient Safety Requires a New Way to Publish Clinical Trials. PLoS Clin Trials 1(1): e6.
PRESS ONLY PREVIEW OF THE ARTICLE: http://www.plos.org/press/pctr-01-01-smith.pdf
PLEASE ADD THE LINK TO THE PUBLISHED ARTICLE IN ONLINE VERSIONS OF YOUR REPORT: http://dx.doi.org/10.1371/journal.pctr.0010006
The Public Library of Science (http://www.plos.org) is a non-profit organization of scientists and physicians committed to making the world's scientific and medical research a public resource. PLoS publishes open-access, peer-reviewed journals including PLoS Biology and PLoS Medicine, available at no cost to anyone in the world with a connection to the Internet.
CONTACTS FOR ARTICLES FEATURED:
(1) Retha Sherrod, Director of Public Relations, Assoc of American Medical Colleges, rsherrod@aamc.org, +1 202 828 0975; Dr. David Korn, Senior Vice President, Div of Biomedical and Health Sciences Research, Assoc of American Medical Colleges, Washington DC, USA; formerly Vice President and Dean of Medicine and Professor of Pathology, Stanford University, Stanford, CA, USA; Dr. Susan Ehringhaus, Assoc of American Medical Colleges, Associate General Counsel for Regulatory Affairs, Washington DC, USA
(2) Dr. Anton JM de Craen, Leiden University Medical Centre, Dept Gerontology and Geriatrics Leiden, The Netherlands, +31-71-5266640, craen@lumc.nl
(3) Professor Ian Roberts, London School of Hygiene and Tropical Medicine, London, UK, +44 (0)20 7958 8128, ian.roberts@lshtm.ac.uk; Dr. Richard Smith, Chief Executive, UnitedHealth Europe, Member of PLoS Board of Directors, Formerly Editor of the British Medical Journal
CONTACTS FOR JOURNAL:
Emma Veitch PhD
Publications Manager, PLoS Clinical Trials
7 Portugal Place, Cambridge, CB5 8AF, UK
eveitch@plos.org
T: +44 (0)1223 463 343
Rita Scheman
Publicity, PLoS Clinical Trials
rscheman@plos.org
T/F: +44 (0)131 664-1694
M: +44 (0)7879 884 746
PLEASE MENTION THE OPEN-ACCESS JOURNAL PLoS Clinical Trials (www.plosclinicaltrials.org) AS THE SOURCE FOR THESE ARTICLES AND PROVIDE A LINK TO THE FREELY-AVAILABLE TEXT. THANK YOU.
All works published in PLoS Clinical Trials are open access. Everything is immediately available without cost to anyone, anywhere--to read, download, redistribute, include in databases and otherwise use--subject only to the condition that the original authorship is properly attributed. Copyright is retained by the authors. The Public Library of Science uses the Creative Commons Attribution License.
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