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Roadmap to help pharma restore research credibility launched

Guidelines from MPIP aim to tackle transparency, conflict of interest and the relationship between industry sponsors and journal editors

A ten-point guide has been published to help restore the credibility of industry-sponsored research, which has been undermined in recent years by ghostwriting scandals, selective publication of results and conflict-of-interest issues.

The document is the work of the Medical Publishing Insights and Practices (MPIP) initiative, which was set up in 2008 to try to improve standards in medical publishing by encouraging better relationships between industry sponsors and journal editors.

Four years on, and the MPIP has published ten recommendations for closing the credibility gap in industry-backed research in the May edition of the Mayo Clinic Proceedings journal.

Among the key messages are a commitment to publicise all research results, including negative findings, in a timely fashion, as well as tighter rules on disclosure of authors' conflicts of interest and a commitment to end ghostwriting.

Many of the recommendations stem from a roundtable meeting between journal editors and pharmaceutical industry sponsors which was organised by the MPIP in 2010.

"While the participants acknowledged that there have been improvement in the conduct and reporting of industry-sponsored studies, they identified opportunities for continued advancement," said Bernadette Mansi, director of medical communications at GlaxoSmithKline.

The complete list of recommendations is as follows:

1. Ensure clinical studies and publications address clinically important questions
2. Make public all results, including negative or unfavourable ones, in a timely fashion, while avoiding redundancy
3. Improve understanding and disclosure of authors' potential conflicts of interest
4. Educate authors on how to develop quality manuscripts and meet journal expectations
5. Improve disclosure of authorship contributions and writing assistance and continue education on best publication practices to end ghostwriting and guest authorship
6. Report adverse event data more transparently and in a more clinically meaningful manner
7. Provide access to more complete protocol information
8. Transparently report statistical methods used in analysis
9. Ensure authors can access complete study data, know how to do so, and can attest to this
10. Support the sharing of prior reviews from other journals.

"This article is intended to serve as a roadmap for how sponsors and journals can collaboratively improve standards for all medical research studies and publications," said Daniel Haller, professor of medicine at the University of Pennsylvania and editor-in-chief emeritus of the Journal of Clinical Oncology.

While many sponsors have committed to making trial results public through registries, there is still room for improvement, he added.

"It is equally important to disclose results that are negative, confirmatory, inconclusive or less immediately relevant to physicians, providing there is not redundancy, duplication or outright plagiarism," said Haller.

While sponsors are asked to work much harder on transparency, journals should also make efforts to improve the dissemination of results, such as novel article formats and review procedures that are less focused on impacts.

"Editors must ensure their policies are clear, transparent, well publicised, and uniformly applied irrespective of author affiliation or study sponsorship, and should increase their collaboration and overall role in promoting best practices," write the article authors.

Conflict-of-interest disclosure and eliminating ghostwriting and guest authorship remains a primary goal of the MPIP.

"Industry should continue to work towards complete disclosure, and in parallel journals should ensure they do not discriminate against industry authors," said Haller.

The measures follow the publication of a set of standards to follow regarding transparency in clinical trials from a group of 16 prominent UK-based healthcare organisations.

29th May 2012

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