2008 has been a good year for access to research. [Several OA policies worldwide were announced, adopted, or implemented ...] Judging by the ever-increasing number of submissions to PLoS journals, authors appear to be voting with their manuscripts for open access to research.
The year is only half over, however, and at least one important milestone is still to come. As of September 27, 2008, the US Food and Drug Administration Amendments Act of 2007 (FDAAA) will require that clinical trials results be made publicly available on the Internet through an expanded “registry and results data bank” [8].
Under FDAAA, enrollment and outcomes data from trials of drugs, biologics, and devices (excluding phase I trials) must appear in an open repository associated with the trial's registration, generally within a year of the trial's completion, whether or not these results have been published. ...
PLoS Medicine and the other PLoS journals endorse timely and accessible reporting at all stages of clinical drug and device development. As we now state in our Author Guidelines: “... Prior disclosure of results on a public website such as clinicaltrials.gov will not affect the decision to peer review or acceptance of papers in PLoS journals” [9].
... In June, members of the World Health Organization's Registry Platform Working Group on the Reporting of Findings of Clinical Trials ... noted that “Although some journal editors have acknowledged the changing climate around results registration and reporting…they may have a conflict of interest in that they will probably want the key (and potentially most exciting) messages from a trial to appear first, and perhaps exclusively, in their publication” [12].
Indeed, one criterion that editors must determine is how much data can be publicly presented without constituting prior publication—standard grounds for disqualifying a manuscript from consideration. ... In 2007, prior to the passage of FDAAA, the International Committee of Medical Journal Editors (ICMJE) had announced that its 12 affiliate journals would permit very limited prepublication presentation of results ... and had noted that “[r]esearchers should be aware that editors may consider more detailed deposition of trial results in publicly available registries to be prior publication” [13].
How will journals adapt such positions in the wake of FDAAA ... ? ...
Traditionally, journal editors have assumed substantial responsibility for, and taken a lead in defining, the quality of research reports that do reach the public. ... Beyond financial concerns, it is therefore appropriate that editors consider the effects that the availability of results outside traditional publication might have. ...
... [W]ill immediate and universal access via the Internet to an ever-increasing number of health-savvy readers provide a better level of scrutiny? ...
In the best case, unfettered access by these parties would provide radical improvements over the current system, in which limited access to data hampers systematic review and abets disingenuous drug marketing. It's not difficult to imagine a vigorous network of skilled evaluators serving as watchdogs over posted data that have been misrepresented or remain unpublished. Perhaps peer-reviewed journals will provide a forum for publishing independent analyses of such datasets. ...
The open access movement:
Putting peer-reviewed scientific and scholarly literature
on the internet. Making it available free of charge and
free of most copyright and licensing restrictions.
Removing the barriers to serious research.
I recommend the OA tracking project (OATP) as the best way to stay on top of new OA developments. You can read the OATP feed on a blog-like web page or subscribe to it by RSS, email, or Twitter. You can also help build the feed by tagging new developments you encounter.
