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| "By making the clinical trial information publicly available we make the system
for ensuring drug safety more transparent and more accountable. That ultimately
leads to an even safer system and greater consumer confidence."
February 28, 2005
Senator Chuck Grassley, R-IA
Co-Sponsor with Sen. Chris Dodd of the FACT Act - Fair Access to Clinical Trials
Act of 2005
About PLoS Clinical Trials
PLoS Clinical Trials is an international, peer-reviewed open-access journal
published by the Public Library of Science (PLoS), a non-profit organization.
PLoS Clinical Trials is due to launch in early 2006 and will welcome manuscript
submissions from autumn 2005. Full text of articles will be deposited in PubMed
Central from the date of publication. PLoS Clinical Trials will be published
only in electronic format at http://www.plosclinicaltrials.org, enabling fast
publication and immediate, maximum access.
Scope
Controlled clinical trials - and particularly randomized trials - are critical
in delivering reliable evidence about the efficacy of an intervention. Clinical
trial data can also provide important information about the potential adverse
effects of treatment. Currently, not all trials on human participants are
reported in the peer-reviewed literature.
PLoS Clinical Trials aims to address this gap. The journal will broaden the
scope of clinical trials reporting by publishing the results of randomized
controlled clinical trials in humans from all medical and public health
disciplines. PLoS Clinical Trials has no bias towards "positive" trial results.
Providing that a submitted trial has been conducted ethically, entered into an
internationally accepted registry, reported accurately and in line with CONSORT
guidelines, PLoS Clinical Trials is in favor of publication.
The website will feature a discussion forum for readers to comment on published
articles. Resources for patients will be developed via a unique portal on
http://www.plos.org.
Registry and Database Links
To maximize access to the published results and links to external datasets, PLoS
Clinical Trials will be online-only. Each published paper in PLoS Clinical
Trials will be linked to its corresponding entry in the relevant registry. PLoS
is collaborating with Global Trial Bank (GTB), a non-profit subsidiary of the
American Medical Informatics Association, to ensure that trial results are
captured and stored in a computer-readable, standardized format. Once a trial is
published in PLoS Clinical Trials, the results data will be coded and entered
into the GTB database for open-access searching, browsing, and data-mining.
Reciprocal links will be created between papers in PLoS Clinical Trials and the
corresponding entries in GTB. More details on this exciting collaboration will
be available soon, both here, and on the GTB website.
Peer Review
Each submitted trial will be rigorously peer reviewed by a statistical reviewer
as well as a clinical researcher in the appropriate specialty. Peer reviewers
will be asked to focus on improving the quality of trial reporting and the
contribution of the trial to current knowledge when preparing recommendations
and their comments to the authors and editors. A summary of the reviews will be
published alongside each article.
Submissions
All trials submitted to PLoS Clinical Trials must have been registered with an
internationally recognized registry - such as the International Standard
Randomised Controlled Trial Number (ISRCTN) Register or ClinicalTrials.gov. The
trial must have been conducted according to the Helsinki guidelines on human
research and must be reported according to the CONSORT criteria.
To submit a manuscript, please contact our editorial staff at
plosclinicaltrials@plos.org.
About Open Access
All articles published in PLoS journals are immediately and freely available
online to anyone, anywhere, to read, download, and redistribute. PLoS only
requires that the author and original source are acknowledged, according to the
Creative Commons Attribution License. Publishing costs are offset by a
publication fee charged to authors, which will be waived for authors with
insufficient funds.
Alan
http://veloceraptor.blogspot.com/
http://theoriginalfirebird.blogspot.com/
http://lordcerneabbastoo.blogspot.com/
http://www.stopwar.org.uk/
http://www.700women.org/
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