Re: PLoS announces PLoS Clinical Trials, new open accessjournal

["Peter Banks" <pbanks@diabetes.org>]

I have trouble seeing how this journal addresses the problem of selective
reporting of positive clinical trials.  PLoS would have us believe that
selective reporting is the fault of traditional journals (as apparently
are many of the world's problems): "Traditional medical journals publish
only the highest profile clinical trials (typically positive trials),
partly because the journals must attract revenues from subscriptions and
selling reprints."

Journals are not the root problem of selective reporting, which has
multiple causes--the non-submission of negative trials by funders, the
failure to vigorously follow up on safety problems suggested in published
trials, and the weakness of regulatory agencies like the FDA in the drug
approval process. Cleveland Clinic cardiologist Eric Topol has published
an excellent and instructive analysis of the failure to examine safety
problems evident in various published and unpublished Vioxx trials
(http://ccjm.org/PDFFILES/Karha12_04.pdf). The existence of PLoS Clinical
Trials would have done little to expose problems inherent in drugs like
Vioxx. In fact, Topol published a 2001 analysis in that most traditional
of journals, JAMA, that suggested a substantial caridovascular risk from
Vioxx--an analysis that failed to attract attention until the APPROVe
trial led to the drug's withdrawl in 2004.

The ICMJE statement on clinical trial registries tries to get at the
problem of selective reporting by ensuring that journal editors and
reviewers, as well as clinicians and the general public, know of at least
the existence of all studies in a given field. The registries do not
contain the results, of course, but the non-publication of trial findings
may raise an index of suspicion.

There may be a need for a clinical trial journal to expose the Vioxx
problems in the making, but PLoS Clinical Trials is probably not it. 

What is really needed is a publication that will publish the work of
investigative researchers who will take the time to rigorously analyze all
available published data, then dig into the registries to find the
unreported findings that may expose the problems not apparent in the
published data.

Peter Banks
Acting Vice President for Publications/Publisher
American Diabetes Association
1701 North Beauregard Street
Alexandria, VA 22311
Email: pbanks@diabetes.org

>>> hdoyle@plos.org 10/18/05 6:30 PM >>>

PLoS Announces Open Access Journal for All Clinical Trials, Positive or
Negative

San Francisco, USA, October 18, 2005 - The Public Library of Science
(PLoS) today announces PLoS Clinical Trials, an innovative new journal
devoted to peer-reviewing and publishing reports of randomized clinical
trials in all areas of healthcare (http://www.plosclinicaltrials.org).
 
The journal differs from other medical journals in one crucial respect.  
It will publish all trials that are ethically and scientifically sound and
entered into an internationally accepted registry, regardless of the
trial's size or whether the results are positive or negative.  PLoS
Clinical Trials is now accepting manuscripts in advance of its spring 2006
launch.
 
Around half of all completed trial reports are thought to go unpublished.
These unpublished trial reports differ systematically from those that are
published in the direction and strength of the findings, thus distorting
the evidence base for decision-making in healthcare.
 
"Unpublished results undermine the trust between patients and
investigators and slow the vast potential of medical progress," says Dr
Christian Gluud of Copenhagen University Hospital, a member of the
Advisory Board of PLoS Clinical Trials.
 
Traditional medical journals publish only the highest profile clinical
trials (typically positive trials), partly because the journals must
attract revenues from subscriptions and selling reprints.  PLoS Clinical
Trials avoids this problem -- it doesn't have to sell subscriptions or
reprints to be viable, so it can publish the broadest range of trials.
 
Citation: Veitch E, PLoS Medicine Editors (2005) Tackling publication bias
in clinical trial reporting. PLoS Med 2(10): e367.  
http://dx.doi.org/10.1371/journal.pmed.0020367
 
CONTACT FOR PLoS CLINICAL TRIALS:
Emma Veitch, PhD
Publications Manager
Public Library of Science
7 Portugal Place
Cambridge CB5 8AF, UK
UK:  01223 463 343
eveitch@plos.org