Comments on PCORI Draft Proposal on Peer Review Process
We appreciate that PCORI has had to balance the time needed for adequate vetting
of study results with the need to make properly vetted results widely available as
rapidly as possible for the benefit of patient care. We believe, however, that the
Draft Proposal leans too far in the direction of deference to existing processes by
some, but by no means all, respected medical journals.
Journal publication processes today are not static, but in a state of rapid evolution,
as newer technologies permit full data sharing, pre-publication posting, versioning
of articles, open peer review, post-publication commenting, and other approaches
that promote openness and public engagement around clinical research. Moreover,
competition among high-quality journals to publish influential work in CER is
substantial. PCORI has already taken the bold step, ahead of many journals, of
requiring prospective protocol registration for observational studies. We encourage
PCORI to continue using its new role, as funder and reviewer of a large body of
clinically important research, to motivate journals to collaborate on better
approaches to comprehensive review and rapid dissemination of research results
for the benefit of the public. Specifically:
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Rather than accepting that journals will take 9 months or more to peer
review and publish a “definitive” version of a study following 3 or more
months of initial review by PCORI, the Institute could collaborate with
journals that are willing and able to coordinate journal and PCORI reviews as
concurrent processes or even a single combined process.
Rather than assuming that journals will refuse to publish work that has been
made available in preliminary format, PCORI could work with journals that
allow pre-acceptance posting of preliminary versions. This is an established
process and there are a number of places where prepublication versions of
papers are now available for public scrutiny; these include clinicaltrials.gov
and bioRxiv.org. Doing so would allowing public comments (with
appropriate disclosure of competing interests) to begin without delay, and
potentially to be integrated into the journal peer review process.
Rather than delaying data availability for many months until a “definitive”
peer reviewed publication appears in a journal, only to be revised or refuted
when further experts are able to re-analyze the study data, PCORI could work
with journals that permit data sharing at an appropriate point prior to
appearance of a “final” publication. PCORI and/or journals could then
integrate external analyses and community discussion into a “living
document,” rather than defending (or abandoning) a “definitive” version that
will necessarily become outdated as more is learned on the topic.
PCORI funding should guarantee the widest possible dissemination and reuse by establishing the expectation that researchers publish their studies
under Creative Commons attribution licenses
(https://creativecommons.org/licenses/), and by providing funding to cover
reasonable article publication charges by journals that provide open access
publication. Otherwise, important work intended to benefit the public will
remain behind subscription paywalls that limit access outside of large
institutions, and locked into copyright restrictions that discourage sharing
and adaptation for broad public use.
We believe that these actions are necessary to ensure transparency, reliability, and
timely access to the research that PCORI is charged to make publicly available.
Respectfully submitted by:
Larry Peiperl MD
Chief Editor, PLOS Medicine
Dr. Virginia Barbour
Medicine and Biology Editorial Director, Public Library of Science