Enhancing the QUAlity and Transparency Of health Research
The Medical Publishing Insights and Practices Initiative (MPIP) has recently published the Five-step Authorship Framework to Improve Transparency in Disclosing Contributors to Industry-sponsored Trial Publications in BMC Medicine. MPIP, in collaboration with academic researchers, conducted a novel qualitative attitude study to identify ambiguities encountered in industry-sponsored trials that are not well addressed by current guidelines.
This research, which included responses from approximately 500 clinical investigators, journal editors, publication professionals and medical writers, led to development of a standardized approach that can be used prospectively to facilitate more transparent and consistent authorship decision-making. The resulting framework reflects close collaboration between journal editors and industry representatives obtained during MPIP roundtables in the USA and UK as well as through broader consultation with those involved in medical publications.
MPIP Five-step Authorship Framework
1. Identify a representative group to establish authorship criteria early in the trial
2. Reach consensus among all trial contributors concerning these criteria
3. Document trial contributions
4. Objectively determine who should be invited to participate in the manuscript development process
5. Ensure authors meet all authorship criteria
David Moher, Associate Professor at the University of Ottawa and member of the CONSORT Group Executive committee, wrote a commentary that accompanied the Five-step Authorship Framework publication. He summed up the value of the framework as, “What is positive about this research is that the proposed attribution process for authorship is brief, and not complex; it’s only five-steps. It is meant to augment the guidance provided by the International Committee of Medical Journal Editors.” He also added, “Disclosing authorship transparently is important for any manuscript being submitted to a biomedical journal for publication consideration. The responsibilities associated with authorship must be taken seriously. This might help increase value and reduce avoidable waste of biomedical research.”
Despite the availability of various authorship guidelines, it can be challenging to bridge the gap between guidelines and practical application when determining authorship. MPIP research found that low awareness, variable interpretation, and inconsistent application of authorship guidelines can lead to confusion and lack of transparency when recognizing those who merit authorship.
The Five-step Authorship Framework helps close this gap while aligning with the latest ICMJE guidance. It can be applied more broadly to all clinical trial publications, not just industry-sponsored research. In doing so, the clinical, pharma and publishing community has a unique opportunity to increase the value of biomedical research.
Links to Five-step Authorship Framework publications can be found here:
Article by Ana Marušić et al available on the BMC Medicine journal website:
Commentary by David Moher available on the BMC Medicine journal website:
MPIP is a cross-disciplinary collaboration between the pharmaceutical industry and the International Society for Medical Publication Professionals (ISMPP) that seeks to continue to elevate trust, transparency and integrity in publishing industry-sponsored studies. For more information about MPIP, visit www.mpip-initiative.org.
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