THANK YOU FOR JOINING ISMPP U TODAY! The program will begin promptly at 11:00 am EDT September 18, 2013
ISMPP WOULD LIKE TO THANK….. …the following Corporate Platinum Sponsors for their ongoing support of the society 2
ISMPP ANNOUNCEMENTS • Mark your calendars! The 2013 European Meeting of ISMPP is on 22 – 23 January 2013, ETC Venues, 200 Aldersgate, St Paul's, London, UK. Registration is now open • Call for Abstracts is open for the 2013 European Meeting. Submission deadline is Friday, September 27, at 5:00pm EST 3
WHAT’S NEW IN PEER REVIEW? AN UPDATE FROM THE 7 TH INTERNATIONAL CONGRESS ON PEER REVIEW AND BIOMEDICAL PUBLICATION Speaker: Trish Groves, MBBS, MRCPsych Speaker: Veronique Kiermer, PhD Moderator: Donna Simcoe, MS, MS, MBA, CMPP tm
OBJECTIVES • At the end of this session, attendees should be able to: – Understand current issues, controversies, and advances in the science of peer review – Be able to implement the new ICMJE criteria for authorship – Be able to implement the updated requirements for declaring conflicts of interest related to submissions to ICMJE member journals 5
INTRODUCTIONS • Speaker: Trish Groves, MBBS, MRCPsych – Trish trained in medicine and psychiatry before going to the BMJ , where she is Deputy Editor and Head of Research. Trish is also Editor-in-Chief of the online-only journal BMJ Open . While at the BMJ , Trish has been a part-time honorary research fellow at the School for Public Policy, UCL; has contributed to European Science Foundation proposals for revising the EU Clinical Trials Directive; has served on the council of the Committee on Publication Ethics; and has helped develop research reporting statements including CONSORT 2010, SPIRIT 2013, and PRISMA extensions. She has presented for TV and radio in the UK and for the BBC World Service, and she co-wrote the HarperCollins Consumer’s Guide to Mental Health (1996). 6
INTRODUCTIONS • Speaker: Véronique Kiermer, PhD – Veronique is Executive Editor and Head of Researchers Services for Nature Publishing Group. She obtained her PhD in molecular biology from the Université Libre de Bruxelles, Belgium. Her postdoctoral work was in the laboratory of Dr Eric Verdin at the Gladstone Institute of Virology and Immunology, University of California, San Francisco, studying the transcriptional regulation of HIV. She then worked on gene therapy projects at the biotechnology company, Cell Genesys, before moving to Nature Publishing Group in 2004. At NPG, she was the founding Chief Editor of Nature Methods and subsequently took on publishing responsibility for the title and other online products. In October 2010, she became Executive Editor, overseeing editorial policies and editorial quality assurance for Nature and the Nature journals. She also heads NPG’s Researchers Services, developing initiatives to benefit scientists in their roles as researchers, authors and referees. – 7
INTRODUCTIONS • Moderator: Donna Simcoe, MS, MS, MBA, CMPP tm – Donna is Publications Director at Cadence Pharmaceuticals, with previous publication experience at AstraZeneca, Wyeth and Cephalon. Donna holds an MS in Biomedical Writing, an MS in Biotechnology and an MBA. She is an active member of AMWA, ISMPP, TIPPA, and CBI, and she is an ISMPP Certified Medical Publication Professional. Donna chairs the ISMPP U committee (2013-2014) and is a member of the ISMPP Annual Planning Committee 8
DISCLOSURES • The information presented reflects the personal knowledge and opinion of the presenters and does not represent those of their current or past employers or those of ISMPP 9
AGENDA • ICMJE Recommendations – new authorship criteria – updated declaration of competing interests • Highlights from the 7 th International Congress on Peer Review and Biomedical publication – authorship – publication bias – data sharing 10
ICMJE’S NEW RECOMMENDATIONS “Uniform Requirements for Manuscripts Submitted to Biomedical Journals” now renamed and updated to: “Recommendations for the Conduct, Reporting, Editing and Publication of Scholarly Work in Medical Journals” http://www.icmje.org/urm_main.html 11
NEW ICMJE RECOMMENDATIONS: AUTHORSHIP • Substantial contributions to: the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; AND • Drafting the work or revising it critically for important intellectual content; AND • Final approval of the version to be published; AND • 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. 12
ICMJE: GUARANTORS Similar to existing guarantor role at some journals. At the BMJ : • one or more contributors are listed as guarantors of the paper. The guarantor(s) accepts full responsibility for the work and/or the conduct of the study, had access to the data, and controlled the decision to publish • the lead author/guarantor is also asked to affirm that the manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned (and, if relevant, registered) have been explained 13
ICMJE: OTHER NEW RECOMMENDATIONS • Updated ICMJE uniform conflict of interest disclosure form, listing entities and suggesting statement such as “I had full access to all of the data in this study, and I take complete responsibility for the integrity of the data and the accuracy of the data analysis.” • Increased time frames for reporting conflicts: from the initial conception and planning of the study to the present, and 36 months for other conflicts • Editors urged to review protocols and/or statistical analysis plans • Editors warned against publication bias for negative studies 14
JOURNALS NOT PART OF ICMJE • Discipline-specific conventions multiple authorship definitions • At Nature journals, authors are required to include a statement of responsibility in the manuscript that specifies the contribution of every author • Credit and accountability • Corresponding author has additional oversight responsibility for ensuring all authors have agreed to final content, verification that figures and conclusions accurately reflect the data, preservation of original data and minimization of obstacles to sharing materials and data 15
7 TH INTERNATIONAL CONGRESS ON PEER REVIEW AND BIOMEDICAL PUBLICATION • Chicago, September 8-10, 2013 • Held every four years • Organized by JAMA and the BMJ • Features 3 days of plenary sessions with original research • Aim is to “improve the quality and credibility of scientific peer review and publication and to help advance the efficiency, effectiveness, and equitability of the dissemination of biomedical information throughout the world” 16
HIGHLIGHTS FROM THE PEER REVIEW CONGRESS (PRC7): AUTHORSHIP Deciding authorship: Survey findings from clinical investigators, journal editors, publication planners, and medical writers. Marušic et al. • Seven scenarios were converted into a case-based, online survey to identify how these groups determine authorship and to assess their awareness and use of authorship guidelines • 498 responses from a global audience of 145 clinical investigators, 132 publication planners, 113 medical writers, and 108 journal editors • Clinical investigators provided the most variable responses and were least aware of ICMJE • Medical Publications Insights and Practices Initiative (MPIP) roundtable then led to guidance aimed at helping authors to set common rules for authorship and document all trial contributions http://www.peerreviewcongress.org/2013/Plenary-Session-Abstracts-9-8.pdf 17
PRC7: PUBLICATION BIAS #1 DO JOURNALS FAVOUR NEGATIVE STUDIES? Role of editorial and peer review processes in publication bias: Analysis of drug trials submitted to 8 medical journals. Van Lent et al. • Retrospective study of manuscripts reporting results of RCTs submitted January 2010-April 30 2012 to BMJ, Annals of the Rheumatic Diseases, British Journal of Ophthalmology, Diabetologia, Gut, Heart, Journal of Hepatology, and Thorax • Among submitted drug trials, 287 (60.8%) had positive and 185 (39.2%) negative results. Of these, 135 (47.0%) and 86 (46.5%), respectively, were rejected immediately, and 91 (31.7%) and 61 (33.0%) after peer review. 98 (20.8%) were accepted • Compared to the number of submitted manuscripts, 60 (20.9%) positive studies were published compared to 38 (20.5%) negative studies http://www.peerreviewcongress.org/2013/Plenary-Session-Abstracts-9-9.pdf 18
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