title: Five-step authorship framework to improve transparency in disclosing contributors to industry-sponsored clinical trial publications.
abstract: Authorship guidelines have established criteria to guide author selection based on significance of contribution and helped to define associated responsibilities and accountabilities for the published findings. However, low awareness, variable interpretation, and inconsistent application of these guidelines can lead to confusion and a lack of transparency when recognizing those who merit authorship. This article describes a research project led by the Medical Publishing Insights and Practices (MPIP) Initiative to identify current challenges when determining authorship for industry-sponsored clinical trials and develop an improved approach to facilitate decision-making when recognizing authors from related publications. A total of 498 clinical investigators, journal editors, publication professionals and medical writers were surveyed to understand better how they would adjudicate challenging, real-world authorship case scenarios, determine the perceived frequency of each scenario and rate their confidence in the responses provided. Multiple rounds of discussions about these results with journal editors, clinical investigators and industry representatives led to the development of key recommendations intended to enhance transparency when determining authorship. These included forming a representative group to establish authorship criteria early in a trial, having all trial contributors agree to these criteria and documenting trial contributions to objectively determine who warrants an invitation to participate in the manuscript development process. The resulting Five-step Authorship Framework is designed to create a more standardized approach when determining authorship for clinical trial publications. Overall, these recommendations aim to facilitate more transparent authorship decisions and help readers better assess the credibility of results and perspectives of the authors for medical research more broadly. Please see related article: http://www.biomedcentral.com/1741-7015/12/214.
authors.affiliation: Department of Research in Biomedicine and Health, University of Split School of Medicine, Šoltanska 2, 21000, Split, Croatia. ana.marusic@mefst.hr.
authors.forename: Ana
authors.initials: A
authors.lastname: Marušić
authors.affiliation: University of Split School of Humanities and Social Sciences, Split, Croatia. dhren@ffst.hr.
authors.forename: Darko
authors.initials: D
authors.lastname: Hren
authors.affiliation: GlaxoSmithKline, King of Prussia, PA, USA. Bernadette.A.Mansi@gsk.com.|Member of MPIP Initiative Steering Committee, Boston, MA, USA. Bernadette.A.Mansi@gsk.com.
authors.forename: Bernadette
authors.initials: B
authors.lastname: Mansi
authors.affiliation: Member of MPIP Initiative Steering Committee, Boston, MA, USA. neil.lineberry@navigant.com.|Navigant Consulting, Boston, MA, USA. neil.lineberry@navigant.com.
authors.forename: Neil
authors.initials: N
authors.lastname: Lineberry
authors.affiliation: Member of MPIP Initiative Steering Committee, Boston, MA, USA. ananya.bhattacharya@bms.com.|Bristol-Myers Squibb, Princeton, NJ, USA. ananya.bhattacharya@bms.com.
authors.forename: Ananya
authors.initials: A
authors.lastname: Bhattacharya
authors.affiliation: Member of MPIP Initiative Steering Committee, Boston, MA, USA. maureen.garrity@astellas.com.|Astellas, Northbrook, IL, USA. maureen.garrity@astellas.com.
authors.forename: Maureen
authors.initials: M
authors.lastname: Garrity
authors.affiliation: Member of MPIP Initiative Steering Committee, Boston, MA, USA. clarkjk@amgen.com.|Amgen, Thousand Oaks, CA, USA. clarkjk@amgen.com.
authors.forename: Juli
authors.initials: J
authors.lastname: Clark
authors.affiliation: Member of MPIP Initiative Steering Committee, Boston, MA, USA. Thomas.Gesell@envisionpharmagroup.com.|On behalf of the International Society for Medical Publication Professionals, Briarcliff Manor, NY, USA. Thomas.Gesell@envisionpharmagroup.com.
authors.forename: Thomas
authors.initials: T
authors.lastname: Gesell
authors.affiliation: Member of MPIP Initiative Steering Committee, Boston, MA, USA. SGlasser@its.jnj.com.|Janssen Research &Development, LLC, Raritan, NJ, USA. SGlasser@its.jnj.com.
authors.forename: Susan
authors.initials: S
authors.lastname: Glasser
authors.affiliation: Member of MPIP Initiative Steering Committee, Boston, MA, USA. John.Gonzalez@astrazeneca.com.|AstraZeneca, Alderley Park, UK. John.Gonzalez@astrazeneca.com.
authors.forename: John
authors.initials: J
authors.lastname: Gonzalez
authors.affiliation: Member of MPIP Initiative Steering Committee, Boston, MA, USA. carolyn_hustad@merck.com.|Merck & Co, Inc, Whitehouse Station, NJ, USA. carolyn_hustad@merck.com.
authors.forename: Carolyn
authors.initials: C
authors.lastname: Hustad
authors.affiliation: Member of MPIP Initiative Steering Committee, Boston, MA, USA. mary.lannon@takeda.com.|Takeda, Deerfield, IL, USA. mary.lannon@takeda.com.
authors.forename: Mary-Margaret
authors.initials: MM
authors.lastname: Lannon
authors.affiliation: Member of MPIP Initiative Steering Committee, Boston, MA, USA. Laverne.Mooney@pfizer.com.|Pfizer, New York, NY, USA. Laverne.Mooney@pfizer.com.
authors.forename: LaVerne A
authors.initials: LA
authors.lastname: Mooney
authors.affiliation: Member of MPIP Initiative Steering Committee, Boston, MA, USA. Teresa.Pena@astrazeneca.com.|AstraZeneca, Wilmington, DE, USA. Teresa.Pena@astrazeneca.com.
authors.forename: Teresa
authors.initials: T
authors.lastname: Peña
mesh_terms: D001319:Authorship / Q000592:standards*; D035843:Biomedical Research / Q000941:ethics / Q000592:standards; D002986:Clinical Trials as Topic / Q000191:economics / Q000941:ethics / Q000592:standards; D016265:Conflict of Interest; D003657:Decision Making; D030881:Disclosure / Q000592:standards*; D004345:Drug Industry / Q000191:economics*; D004995:Ethics, Professional; D005378:Financial Support / Q000941:ethics; D006801:Humans; D017410:Practice Guidelines as Topic; D011642:Publications / Q000941:ethics / Q000592:standards