1. Good Publication Practice for Communicating Company-Sponsored Medical Research: GPP3 Yvonne E Yarker, PhD, ISMPP CMPP TM President, Medicite LLC; Chair, Board of Trustees, International Society for Medical Publication Professionals (ISMPP)

2. Disclosure and Acknowledgements Disclosures I am Chair of the Board of Trustees of the International Society for Medical Publication Professionals (ISMPP) and an author of the Good Publication Practice Guidelines (GPP2 and GPP3). The opinions presented today are my own and do not necessarily reflect those of ISMPP or my GPP coauthors. Acknowledgments Many of the slides in this presentation were created by members of the GPP3 Steering Committee. I thank the Steering Committee for their contributions to this presentation.

3. What is ISMPP? I nternational S ociety for M edical P ublication P rofessionals www.ISMPP.org Founded in 2005

4. ISMPP Membership Representation from those involved in the publication of medical research – Medical communication agencies: 51% – Pharmaceutical/Biotech/Device industries: 36% – Medical Journal Editors/Publishers: 5% – Other: 5% (eg, freelance, nonprofit) – Academia: 2% – Technology: 1%

5. ISMPP Membership Growth by Year *through June 30, 2016

6. Current ISMPP Membership: Geographic Breakdown

7. ISMPP Asia-Pacific Members: Regional Trends 2013–2016

8. WHAT IS GPP?

9. Good Publication Practice (GPP) Guidelines: Aims and Scope Good Publication Practice (GPP) guidelines provide recommendations for individuals and organizations that contribute to the publication of research sponsored or supported by pharmaceutical, biotechnology, medical device, and diagnostics companies Applies to publications in peer-reviewed journals and presentations at scientific congresses Current version is GPP3

10. Research Misconduct Identified by the US Food and Drug Administration: Out of Sight, Out of Mind, Out of the Peer-Reviewed Literature Charles Seife, MS JAMA Internal Medicine April 2015 Volume 175, Number 4 Misconduct in Medical Research, Increased Scrutiny, and Public Mistrust Commentary: Should you put your trust in medical research? Cory Franklin June 8, 2015 Mar 20, 2014 @ 11:53 AM 1,960 views Medical Research Fraud And HHS's Office Of Research Integrity: Watching The Watchdog COMMENTARY Ghostwriting: Research Misconduct, Plagiarism, or Fool’s Gold?

11. Transparency Accountability Responsibility Integrity Completeness Why are Good Publication Practice Guidelines Important? Provide guidance on how to responsibly and ethically develop and publish findings from industry- sponsored research Encourage accurate, complete, and transparent reporting and a c ommitment to integrity and accountability GPP3 guidelines are broadly applicable to non- industry-sponsored research, eg, academic research and government-funded work

12. EVOLUTION AND DEVELOPMENT OF GPP3

13. GPP Evolution

14. GPP3 Process: 4 Key Steps ISMPP Steering CommitteeReviewer PanelSteering Committee ISMPP emails >3000 invitations to members, journal editors, and previous GPP2 reviewers ( Sept 2013 ) o Steering Committee (n=18) selected from applicants (N=118) o External reviewer panel (n=153) selected o Additional targeted outreach to medical journal editors: 21 agreed Reviewed earlier GPP guideline and literature; collated comments for proposed changes ( Dec 2013 – Feb 2014 ) Confirmed scope, and title for GPP3 via repeated survey process of Committee members ( Jan-Feb 2014 ) Prepared outline ( March 2014 ) Formed subcommittees to update or write each section ( April–June 2014 ) First draft assembled and edited; reviewed by full SC; draft finalized ( Aug 2014 ) Finalized draft (2 nd draft) sent to reviewers (N=174) Aug 2014 Reviewers allowed 5 weeks to comment via Excel spreadsheet Comments captured by section heading and line number Reviewers (n=94) provided comments Reviewed and ranked comments ( Sept-Oct 2014) from reviewer panel by: o Frequency o Rating o Individual judgment SC reviewed all comments and identified top issues and resolution needed Addressed comments Guidelines finalized for submission to Annals of Internal Medicine ( Jan 2015 )

15. GPP3: Global Participation Geographic Representation Steering Committee from 7 countries Professional Representation Steering Committee (N=18) Industry (pharmaceutical and device) Medical communication agencies Medical journal editors Journal publishers Freelance writers Reviewer Panel (N=94) Industry (pharmaceutical and device) Medical communication agencies Medical journal editors (n=21) Sponsor International Society for Medical Publication Professionals (ISMPP)

16. GPP3 Published in Annals of Internal Medicine, August 2015 Battisti et al. Ann Intern Med 2015;163:461-464.

17. WHAT DOES GPP3 RECOMMEND?

18. All clinical trials should be reported in a complete, accurate, balanced, transparent, and timely manner Reporting and publication processes should follow applicable laws and guidelines Journal and congress requirements should be followed, particularly to avoid duplicate publication Publication planning and development should be a collaboration, reflecting the collaborative nature of research and the range of skills required to conduct, analyze, interpret, and report research findings Rights, roles, requirements, and responsibilities of all contributors should be confirmed in writing, ideally at the start of the research and, in all cases, before publication preparation begins All authors should have access to relevant aggregated study data and other information required to understand and report research findings Authors should take responsibility for the way that research findings are published, be fully involved at all stages of publication development, and be willing to take public responsibility for all aspects of the work Author lists and contributorship statements should accurately reflect all substantial intellectual contributions to the research, data analyses, and publication development. Relevant contributions from non-authors should also be disclosed Role of the sponsor in the research should be fully disclosed in all publications. Involvement by persons or organizations with an interest in the findings should also be disclosed All authors and contributors should disclose any relationships or potential competing interests relating to the research and its publication 01 02 03 04 05 07 06 09 08 10 10 Principles of GPP3

19. What and When to Publish Authorship Principles, Payments & Disclosures Professional Medical Writers Data Sharing & Transparency What’s New in GPP3?

20. What and When to Publish WHAT Ideally, all clinical trials should be published in peer-reviewed journals Regardless of whether positive, negative, or inconclusive, or Whether intervention is investigational, licensed, or discontinued or withdrawn from market This includes difficult-to- publish and terminated studies WHEN GPP3 recommendations are closely aligned with EFPIA Submit for publication by 12 months (latest 18 months) – After study completion for approved products – After approval for investigational products – After discontinuation decision All clinical trials should be reported in a complete, accurate, balanced, transparent, and timely manner 11 What and When to Publish

21. Difficult-to-Publish Studies Not all research reports will be readily accepted at the journal of the authors' choice – 'Negative' or inconclusive results (although some journals state that they will publish these studies) – Studies that do not change clinical practice or are confirmatory After several submissions to and rejections from appropriate journals – Authors may consider posting results on a registry, eg, clinicaltrials.gov or EudraCT to ensure that the data appear in the public domain

22. Terminated Studies Studies that have recruitment problems (enroll fewer patients than planned) or are terminated by the sponsor for business reasons may not have sufficient data to test the hypothesis – Posting findings on a public registry to make the data available to other researchers and the public Studies terminated for safety reasons should always be made public – Small patient numbers should not be an excuse for not publishing/posting

23. Several Principles Relating to Authorship 5. The rights, roles, requirements, and responsibilities of all contributors (ie, authors and any nonauthor contributors) should be confirmed in writing, ideally at the start of the research and, in all cases, before publication preparation begins. 6. All authors should have access to relevant aggregated study data and other information (e.g the study protocol) required to understand and report research findings. 7. The authors should take responsibility for the way in which research findings are presented and published, be fully involved at all stages of publication and presentation development, and be willing to take public responsibility for all aspects of the work. 8. Author lists and contributorship statements should accurately reflect all substantial intellectual contributions to the research, data analyses, and publication or presentation development. Relevant contributions from persons who did not qualify as authors should also be disclosed. 10. All authors and contributors should disclose any relationships or potential competing interests relating to the research and its publication or presentation Authorship Principles, Payments & Disclosures

24. 11 Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work 22 33 Drafting the work or revising it critically for important intellectual content Final approval of the version to be published Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved 44 Authors must meet all 4 criteria Authorship Criteria (2.3.1) www.icmje.orgwww.icmje.org. Battisti et al. Ann Intern Med 2015;163:461-464. Defines what is/is not a substantial contribution and provides examples Provides clarity on what constitutes a critical revision Important for the author to read the entire manuscript Each author is accountable for the work and should have confidence in the integrity of other authors’ contributions

25. Authorship Application and Guidance (2.3.2) Guidance on 'guest' and 'ghost' authorship – Authorship criteria should be applied consistently; all listed authors must fulfill the authorship criteria (ie, no guest authors) – All those who fulfill the criteria must be listed as authors, including company- or sponsor-employed authors and contractors (ie, no ghost authors) Authorship must not be used as a reward or gift for services; the following activities alone are not sufficient – Trial enrollment or technical assistance (eg, laboratory assistance, data acquisition, statistical programming, clinical trial management, or editing services) – Acquisition of funding or supervision of a research group or department

26. Author Payment & Reimbursement (2.3.3) Payments allowed in certain limited circumstances Never to “attract” someone or to influence an author’s opinion Never to persons employed by an institution or organization where these activities are already part of their job Can be made to reimburse reasonable expenses (eg, travel expenses to present a poster at a congress) or for other publication-related activities (eg, statistical analysis, medical writing/editing) to assist authors when developing publications. Payments should reflect the services provided and be at fair market value Difficult to prove specific intent, thus sponsors may choose to adopt policies that prohibit compensation for time spent writing a publication or presentation

27. Professional Medical Writers (2.4) 2.4.2: Working With Authors 1.The authors will control and direct the content of the publication or presentation. The writer must receive direction from the authors at the earliest possible stage (for example, before the outline is prepared). 2.All authors have agreed to the writer's involvement. 3.All authors have a documented agreement with the sponsor that identifies their respective rights, roles, and responsibilities. 4.The authors will disclose, at a minimum, the writer's name, professional qualifications, affiliation, funding source, and any other information required by the journal or congress. 5.Good publication practices will be followed. Professional Medical Writers

28. Data Sharing (5.0) Regulations, recommendations, and journal requirements are evolving rapidly – Some journals require original data to be provided on request – Some require inclusion of a ‘data sharing’ statement – Some request patient-level data GPP3 – Recommends following applicable rules, legislation, and guidelines (including journal requirements) – Recommends that sponsors grant access to anonymous patient-level data to qualified researchers on request Data Sharing & Transparency

29. WHAT NEXT?

30. GPP3 Endorsements and Support Japan Medical and Scientific Communicators Association Committee on Publication Ethics (UK) American Medical Writers Association European Medical Writers Association European Association of Science Editors EQUATOR has included GPP3 on their website www.equator-network.org www.equator-network.org

31. GPP3 Ongoing Activities Global Training and Presentations – Steering Committee presentations at local and national meetings – GPP3 sessions at ISMPP and other congresses GPP3 Translations – July 2016: Chinese version available on ISMPP website – October 2016: Japanese version to be released GPP3 Reprints – Annals of Internal Medicine will offer all requestors nonprofit pricing for reprints of GPP3 – Refer to ISMPP website for request/contact information: http://www.ismpp.org/gpp3-reprint-infohttp://www.ismpp.org/gpp3-reprint-info

32. GPP3 Chinese Translation

33. GPP3 Website and Subcommittee GPP3 Website and Subcommittee set up to – Monitor and respond to queries about GPP3 – Develop additional training materials – Update website on an on-going basis, including GPP3 for authors’ checklist – practical tool Frequently Asked Questions (FAQs) ISMPP assisting with updating website and posting FAQs

34. GPP3 Summary Publishing pharmaceutical industry research is complex, with legal and regulatory requirements, and many stakeholders with diverse expertise and priorities GPP3 and related guidelines aim to: – Improve ethical and transparent publication practices – Provide high quality, complete, and accurate publications in the scientific/medical literature – Ultimately, provide benefit to patients Good Publication Practices Transparency Completeness Accuracy Responsibility Accountability Integrity

35. ISMPP Events in the Asia-Pacific Region 2015: ISMPP Asia-Pacific Meetings – Beijing, China – Tokyo, Japan Q3-Q4, 2016: Asia-Pacific ‘Best of ISMPP’ Events – Shanghai, China – Tokyo, Japan – Singapore – Mumbai, India Q3, 2017: ISMPP Asia-Pacific Meeting – Tokyo, Japan – Call for volunteers and speakers: contact apmeeting@ismpp.org apmeeting@ismpp.org – Planned for every 2 years in different countries/regions

36. THANK YOU