One of the key challenges in publishing industry-sponsored research is improving transparency and trust. To address the best practices related to the dissemination of results from industry-sponsored trials and to raise the standards in medical publishing, the Medical Publishing Insights and Practices (MPIP) Initiati ve (www.mpip-initiative.org) was founded in 2008. MPIP was briefly introduced by the moderator of the session, Patricia Baskin. Current industry members include Amgen, AstraZeneca, Biogen, Bristol-Myers Squibb, GlaxoSmithKline, Janssen Research & Development LLC, Merck, Pfizer, and Takeda. More than 75 senior editors of worldwide biomedical journals have participated in MPIP activities.
The session speaker was LaVerne Mooney, representative of Pfizer in the MPIP, and one of the coauthors of the recent publication in BMC Medicine addressing the fivestep authorship framework.1 She referred to “Ten Recommendations for Closing the Credibility Gap in Reporting IndustrySponsored Clinical Research”, created by the initiative.2 One recommendation was to improve disclosure of authorship contributions and writing assistance and continue education on best publication practices to end ghostwriting and guest authorship.
To address this recommendation, MPIP identified the authorship challenges arising from the current guidelines and converted them into seven authorship case scenarios. These served as the basis for a survey distributed to journal editors, clinical investigators, publication professionals and medical writers. The final sample consisted of 498 respondents fairly representing the four groups. The major questions determining the case scenarios were
- Does patient recruitment count as a substantial contribution?
- Can an author be added after drafting has begun?
- Can an author remove his or her name from recognition?
- How should contributions from a medical writer be recognized?
- How should external contracted work be evaluated for authorship?
- What can be done when an author does not provide final approval?
- What happens when a contributor leaves before trial completion?
As a result of the survey analysis, a fivestep authorship framework was created. The first four steps should be done before inviting authors and before manuscript writing begins, and the final step once the writing of the manuscript begins. The five steps are
- Establish an authorship working group of core trial contributors as close as possible to trial start.
- Determine, in the context of the International Committee of Medical Journal Editors (ICMJE) authorship criteria and the specific trial, which authorship contributions are “substantial”.
- Implement a process to track and document contributions.
- Assess documented contributions to invite authors (e.g., protocol development, enrollment, meetings, author–editor management, etc).
- Ensure that invited authors meet remaining ICMJE authorship criteria.
Each of the MPIP Steering Committee member companies is in the process of implementing these best-practice recommendations. Further collaborations with additional organizations are developed to drive outreach and education. MPIP continues to build awareness of industry tools for authorship and gather additional feedback on the framework. The subsequent discussions concerned the real-world application of the MPIP process to manuscripts from pharmaceutical trials. The framework is used to aid in the consistent application and interpretation of authorship criteria (e.g., ICMJE). Also, the framework is flexible and can be applied to other authorship criteria used by journals that have not adopted the ICMJE guidelines. In conclusion, everybody agreed that in all cases, the best strategy related to authorship issues is to define everything in advance.
- Marušić A, Hren D, Mansi B, Lineberry N, Bhattacharya A, Garrity M, Clark J, Gesell T, Glasser S, Gonzalez J, Hustad C, Lannon MM, Mooney LA, Peña T. Five-step authorship framework to improve transparency in disclosing contributors to industry-sponsored clinical trial publications. BMC Med. 2014;12(1):197.
- Mansi BA, Clark J, David FS, Gesell TM, Glasser S, Gonzalez J, Haller DG, Laine C, Miller CL, Mooney LA, Zecevic M. Ten recommendations for closing the credibility gap in reporting industry-sponsored clinical research: a joint journal and pharmaceutical industry perspective. Mayo Clin Proc. 2012;87(5):424–429.