TODAY! The program will begin promptly at 11:00 am EDT September 18, - - PowerPoint PPT Presentation

The program will begin promptly at 11:00 am EDT

THANK YOU FOR JOINING ISMPP U TODAY!

September 18, 2013

ISMPP WOULD LIKE TO THANK…..

…the following Corporate Platinum Sponsors for their

• ngoing support of the society

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ISMPP ANNOUNCEMENTS

• Mark your calendars! The 2013 European Meeting of ISMPP is
• n 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

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WHAT’S NEW IN PEER REVIEW? AN UPDATE FROM THE 7TH INTERNATIONAL CONGRESS ON PEER REVIEW AND BIOMEDICAL PUBLICATION

Speaker: Trish Groves, MBBS, MRCPsych Speaker: Veronique Kiermer, PhD Moderator: Donna Simcoe, MS, MS, MBA, CMPPtm

OBJECTIVES

• At the end of this session, attendees should be able to:

– Understand current issues, controversies, and advances in the science

• f peer review

– Be able to implement the new ICMJE criteria for authorship – Be able to implement the updated requirements for declaring conflicts

• f interest related to submissions to ICMJE member journals

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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).

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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.

–

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INTRODUCTIONS

• Moderator: Donna Simcoe, MS, MS, MBA, CMPPtm

– 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

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DISCLOSURES

• The information presented reflects the personal knowledge and
• pinion of the presenters and does not represent those of their

current or past employers or those of ISMPP

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AGENDA

• ICMJE Recommendations

– new authorship criteria – updated declaration of competing interests

• Highlights from the 7th International Congress on Peer Review

and Biomedical publication

– authorship – publication bias – data sharing

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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.

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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

• f 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

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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

• ther conflicts
• Editors urged to review protocols and/or statistical analysis plans
• Editors warned against publication bias for negative studies

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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

• f original data and minimization of obstacles to sharing materials

and data

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7TH 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”

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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

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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

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PRC7: PUBLICATION BIAS #2 DISCREPANT REPORTING OF RESULTS

Reporting of results in ClinicalTrials.gov and published articles: A cross-sectional study. Becker et al.

• Clinical trials published July 2010-June 30, 2011, in journals (Impact Factor ≥10)
• Of 95 included clinical trials registered and reporting results on ClinicalTrials.gov, there

were 96 corresponding publications, among which 95 (99%) had at least 1 discrepancy in reporting of trial details, efficacy results, or adverse events between the 2 sources.

• Results for 30 of 132 (23%) primary endpoints could not be compared because of

reporting differences between the 2 sources (eg, tabular vs graphics); among the remaining 102 endpoints, reported results were discordant for 21 (21%), altering interpretations for 6 (6%).

http://www.peerreviewcongress.org/2013/Plenary-Session-Abstracts-9-9.pdf

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PRC7: PUBLICATION BIAS #3 RESTORING INVISIBLE AND ABANDONED TRIALS

Annual EQUATOR lecture at Peer Review Congress by Professor Kay Dickersin, Johns Hopkins, explained the RIAT initiative: Doshi P, Dickersin K Healy D, Vedula SS, Jefferson T. Restoring invisible and abandoned trials: a call for people to publish the

• findings. BMJ 2013;346:f2865

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PRC7: MORE ON DEVELOPING RIAT MANUSCRIPTS

Proposal for restoring invisible and abandoned trials (RIAT) for researchers to:

1.

Obtain clinical study reports and any other previously hidden study data

2.

Collect documentation of trial abandonment

3.

Issue a “call to action” by publicly registering possession of data sufficient for publication

4.

Collect documentation of the need for restoration of trial

5.

Presubmission inquiry to RIAT-friendly journal

6.

Prepare and submit manuscript according to RIAT procedures

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PRC7: PUBLICATION BIAS

• Under-reporting of studies – comparison of published record

versus registration and study descriptions in conference abstracts

• Selective reporting of outcomes
• Selective reporting of analyses
• Spin in reporting

http://www.peerreviewcongress.org/2013/Plenary-Session-Abstracts-9-9.pdf 22

PUBLICATION BIAS IN BASIC RESEARCH

NRDD 2011 doi: nrd3439 Nature 2012 doi:10.1038/483531a

32% of studies: Results fully

• r partially

reproduced 43% of studies: inconsistencies

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PUBLICATION BIAS IN BASIC RESEARCH: UNDERLYING ISSUES AND REACTIONS

• Negative results not being published
• Some published studies suffer from lack of rigor in design and

execution of experiments, and over-interpretation of results

• Experimental bias, poor use of statistics, reagents validity

(antibodies, cell lines), ‘big data’ difficult to scrutinize

• Journals can respond by improving reporting standards,

increasing statistical robustness, and mandating data deposition

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REDUCING IRREPRODUCIBILITY AT NATURE JOURNALS

Following lead of medical journals:

• New reporting checklist
• Statistical reviews
• No length restriction
• n methods sections
• Continue to enforce

data deposition

• Encourage source data.

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PUBLICATION BIAS IN BASIC RESEARCH: SOLUTIONS

“Learning to live with small and tiny effects”

• - John Ioannidis

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PRC7: DATA SHARING WHAT DO AUTHORS AGREE TO SHARE?

Reproducible research: Biomedical researchers’ willingness to share information to enable others to reproduce their results. Laine et al.

• Review of Annals of Internal Medicine reproducible research statements for research

articles since 2008, stating whether and under what conditions authors would make available to others their protocol, statistical code, and data

• Of 389 articles, 17% stated that protocol was available without conditions, 54% with

conditions, and 29% not available. Statistical code was available without conditions for 6%, with conditions for 66%, and unavailable for 28%. Data were available without condition for 7%, with conditions for 47%, and unavailable for 46%

• Over the years authors’ willingness to share protocol and data decreased

http://www.peerreviewcongress.org/2013/Plenary-Session-Abstracts-9-9.pdf

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DATA SHARING IN BASIC RESEARCH

At Nature journals:

• An inherent principle of publication is that others should be able to

replicate and build upon the authors' published claims

• Therefore, a condition of publication in a Nature journal is that authors

are required to make materials, data and associated protocols promptly available to readers without undue qualifications

• Any restrictions on the availability of materials or information must be

disclosed to the editors at the time of submission and in the submitted manuscript, including details of how readers can obtain materials and information

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DATA SHARING IN BASIC RESEARCH (CONT’D)

• The preferred way to share large data sets is via public

repositories*

– Any supporting data sets for which there is no public repository must be

made available as Supplementary Information files that will be freely accessible on nature.com upon publication

*Data deposition in a public repository is mandatory for: protein, DNA, RNA sequences,

macromolecular structures, crystallographic data for small molecules, microarray data

PRC7: Ioannidis pointed out that policies alone are not sufficient Nature Genetics:2009;41:149

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QUESTIONS......

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 PRESENTATIONS

• Date: in October TBD
• Topic: Center for Information & Study on Clinical Research

Participation (CISCRP)

• Presenter: Kenneth Getz (Tufts)
• Date: in November TBD
• Topic: Steering Committees
• Presenters: Ken Pomerantz (Boehringer-Ingelheim) Brian

Scheckner (Shire)

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