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Ghost writers
Thank you for joining ISMPP U today! The program will begin promptly at 11:00 am EST ISMPP would like to thank… the following Platinum Sponsors for their ongoing support of the society Today’s Program • Presenter Chris Graf, Wiley-Blackwell • Moderator Beth Young, PhD, CMPP • Q&A follows the presentation−but feel free to send in questions as you have them GPP2 Chris Graf Wiley-Blackwell, Associate Editorial Director Publisher, International Journal of Clinical Practice [email protected] +44 1865 476 393 GPP2 Steering Committee • Wendy Battisti, Johnson & Johnson • James Gurr, Pfizer • Dan Bridges, Excerpta Medica, Elsevier • Mary-Ellen Marx, PharmaWrite • Victoria Bruce-Winkler, Dunblane, UK • Jane Moore, Medtronic • Joanne Conaty, AstraZeneca • Mina Patel, Cephalon • John Draper, Peloton Advantage • Carol Sanes-Miller, AstraZeneca • John Ellison, LifeScan • Yvonne Yarker, KnowledgePoint360 • Elizabeth Field, Field Advantage Medical Communications • And me… Disclosure • Disclosures for Chris Graf: Lead author GPP2; Board member of ISMPP; Council member of COPE Disclaimer • The opinions expressed here do not necessarily represent those of the authors’ employers • Role of the sponsor, contributions, acknowledgements, funding, disclosures of competing interest for all authors are described in detail in BMJ 2009;339:b4330 BMJ 2009;339:b4330 gpp-guidelines.org http://www.flickr.com/photos/its-only-lines/361847312/ BMJ 2009;339:b4330 116 comments on first draft Professional organisation Academic centre or university Journal editor Drug, medical device, or biotechnology company Journal publisher Medical communication agency, freelance medical writer What’s new, updated? • Lead author, guarantor, publication steering committee, medical writers • Reimbursement, honoraria • Publication planning, documentation • Defining roles, including sponsor’s • Checklists Too much to cover, so… • Publication steering committees • Authors • Professional medical writers • Publication planning Publication steering committee • It may be useful to form a publication steering committee … of authors and contributors … to oversee and produce articles and presentations from a research study Publication steering committee • Members of the study steering committee and the protocol development team • and… Publication steering committee • Investigators and other individuals who have expertise in the area and who are willing to interpret the data and write or review articles and presentations • and… Publication steering committee • Employees of, or contributors contracted by, the sponsor company who are involved in the study … (for example, clinicians, statisticians, or professional medical writers) Publication steering committee • We recommend that… • It should be formed early (when the protocol is finalised or at end of enrolment) • All investigators know about its membership, responsibilities • Authors, contributors agree to their roles before writing begins http://www.flickr.com/photos/icedsoul/3032507196/ Authors • We recommend using the criteria for authorship described in the ICMJE “Uniform Requirements” Authors • ICMJE criteria allow assignment of authorship to individuals who have contributed to the analysis and interpretation of a study …but who may not have contributed to its conception and design Authors • We recommend that authorship criteria are applied consistently to all contributors to an article or presentation … including investigators, sponsor employees, and individuals contracted by the sponsor Authors • Before writing begins one author (“lead author” who may also be “guarantor”) should take the lead for writing and managing each publication or presentation • One author (“guarantor”) should take overall responsibility for the integrity of a study and its report Authors, all contributors • We recommend that clear, concise descriptions of the role performed by each contributor during preparation of the article or presentation (including but not limited to the authors) are made http://www.flickr.com/photos/gpayne85/3542928915/ Professional medical writers • Professional medical writers should ensure that authors control and direct writing … and that disclosures of funding, potential conflicts of interest and acknowledgement of contributions are made Professional medical writers • Professional medical writers must be directed by the lead author from the earliest possible stage … and all authors must be aware of the medical writer’s involvement Professional medical writers • The authors must critically review and comment on the outline and drafts … approve the final version of the article or presentation before it is submitted … approve changes made during the peer-review process … approve the final version before it is published or accepted for presentation Professional medical writers • Professional medical writers, depending on the contributions they make, may qualify for authorship • We recommend that particular care is taken to ensure appropriate acknowledgement of the contributions made by medical writers and to describe their funding Professional medical writers • We recommend authors, professional medical writers use a published checklist to discourage ghostwriting http://www.flickr.com/photos/seven13avenue/2355963809/ Publication planning • We recommend that companies, and the organisations or individuals working for them, document how publications are initiated and developed Publication planning • A publication plan should support authors and publication steering committees … in their efforts to ensure appropriate, efficient, and complete communication of results Publication planning • Identifying submission deadlines for relevant congresses • Determining which studies are appropriate to present and might have data available • Identifying areas for new publications (sub-group analyses, topics for pooled data analyses, post hoc analyses, systematic reviews) Publication planning • Identifying the resources required, such as statistical analyses • Avoiding premature release of results • Avoiding duplicate publication Documentation • We recommend that companies implement policies detailing the types of documentation to be retained Documentation • Agreements to participate • Details of intellectual input, direction, and contributions • Main versions of the draft • Workflow, timelines • Approval from authors • Lists of who reviewed or commented Checklists • GPP2 checklist for articles and presentations • GPP2 checklist of basic requirements for written publication agreements • Too big for here… check them in the actual article http://www.flickr.com/photos/toechsner/2882757624/ Questions & Answers To ask a question, please type your query into the ‘Q&A’ chat box at the bottom left of your screen. Every attempt will be made to answer all questions. Next ISMPP U DATE: January 13th TIME: 11am EST TOPIC: CMPP Primer: What You Need to Know Thank you for attending! We hope you enjoyed today’s presentation. Please take a moment to fill out the survey sent to you after today’s program so you can provide valuable feedback, as it will help us to develop future educational offerings.
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