Calls for changes to trial publication process
pharmafile | May 11, 2010 | News story | Medical Communications, Research and Development | industry relations, industry reputation, publication
Clinical trial publishing has not kept pace with changes in the way pharma carries out its research, according to a new report.
The Medical Publishing Insights and Practices (MPIP) initiative says that while research, spurred by changes in policy, regulation and technology, has made improvements in transparency and efficiency in recent years, publishing has stuck with its traditional model.
In a paper published by the International Journal of Clinical Practice, the MPIP says this is a concern because more trials are now being published, and in a more exhaustive manner, than ever before.
The MPIP is a collaboration between the International Society for Medical Publication Professionals and the pharmaceutical industry. It is sponsored by the ISMPP and, on the industry side, Amgen, AstraZeneca, GlaxoSmithKline and Pfizer.
It says the publishing ‘ecosystem’ may soon be unable to accommodate the number of manuscript submissions – unless a new approach is taken.
It wants to see a more collaborative approach from editors, publishers, academic researchers and funders to develop “systems for publishing research that are sustainable and effective in our mutual goal of improving healthcare through the efficient and transparent transmission of knowledge”.
The report acknowledges that distrust and low credibility have become barriers to mutually beneficial relationships between big pharma and journal editors/publishers.
“Rebuilding trust begins with mutual understanding and insight, the overarching objective of the Medical Publishing Insights and Practices initiative is to obtain insights from journal editors/publishers that can lead to more effective partnership and solutions to increase trust and transparency in publishing of pharma-sponsored research,” it says.
A flood of publications
One of the key drivers behind the changes was the 2007 FDA mandate that required summaries of trial results to be published on its ClinicalTrials.gov website within 12 months of a study end.
The site doesn’t allow textual introduction or interpretation, which is leading many sponsors to seek to publish a journal article at the same time in order to provide greater context and transparency.
One major company estimates that, prior to the rule change, about 90% of phase I studies and 60% of phase II studies didn’t appear in journals because, being mainly confirmatory in their results, they were not deemed worthy of publication.
The best way of coping with an expected flood of new publications was recently discussed at an MPIP roundtable meeting, which included participants from the BMJ, The Lancet, the British Journal of Clinical Pharmacology, Wiley-Blackwell and all pharma co-sponsors.
There a range of possible solutions were outlined, including:
• Alternative formats for trial data that work around the space constraints in print journals
• Greater focus on electronic publication for quicker dissemination of results
• Promotion of practice guidelines to help curb the lack of trust in industry-funded publications
Medical Publishing Insights and Practices (MPIP) initiative
The MPIP initiative was set up to elevate trust, transparency and integrity in publishing industry-sponsored studies and first met in 2008 to discuss the issues surrounding the new ‘disclosure paradigm’.
The first phase of its work focused on obtaining the insights of editors and publishers on the so-called ‘barriers of transparency’ on the publication of industry-funded trials.
The second phase, which began in April of last year and is ongoing, is focusing on implementing solutions to problems raised by the first round of talks.
Ben Adams
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