Welcome to the FIRST ISMPP Asia-Pacific webinar
Good Publication Practice 2
in the Asia-Pacific region
Tuesday, 16 October 2012
(during your morning, afternoon, or evening!)
Moderator:
Professor Karen Woolley (WU Kai-run)
2
Thank you to all attendees… wherever you may be!
ISMPP AP Webinar 16 Oct 2012
Ni hao
Annyeong haseyo
Konnichi wa
Hello
Namaste Sawadee kah
Selamat siang
Kamusta po kayo
Lei hou
Selamat tengahari
Kia ora
Xin chao
3
Mouyue WANG
Editor
China
Jeonghee HAN
Academia, Industry
South Korea
Xiaoling WANG
Industry
China
Yuko KOJIMA
Industry
Japan / China
Roselynn TIEN
CRO
Singapore
Karen WOOLLEY
(WU Kai-run)
Academia, CRO
Australia
Chris GRAF
Publisher, COPE
Australia (UK)
Thank you to ISMPP and the Asia-Pacific Advisory Committee
ISMPP AP Webinar 16 Oct 2012
4
International Society for Medical Publication Professionals
ISMPP AP Webinar 16 Oct 2012
• ISMPP (not-for-profit)
– > 1000 members • Write, plan, edit, publish, peer-review, research…
– Conferences • European Meeting (London; January 2013)
• Annual Meeting (Baltimore; April 2013)
– International certification • Certified Medical Publication Professional (CMPP)
• Next exam - March 2013
• Testing centres (throughout AP region!)
5
Agenda
• Welcome
• Introduction and poll questions
• Overview of GPP2
– Chris GRAF
• Applying GPP2 in the Asia-Pacific region
– Yuko KOJIMA
• (Video)
• Questions and, hopefully, answers!
ISMPP AP Webinar 16 Oct 2012
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Yin yang of publications - quantity and quality
7
Quantity - increasing contribution from the Asia-Pacific region to the international medical literature
© ProScribe 2012. Figure courtesy of ProScribe Medical Communications
0
200,000
400,000
600,000
800,000
2002 2003 2004 2005 2006 2007 2008 2009 2010 2011
To
tal N
um
be
r o
f P
ub
lic
ati
on
s
Year of Publication
Total AP
USA
0
200,000
400,000
600,000
800,000
2002 2003 2004 2005 2006 2007 2008 2009 2010 2011
To
tal N
um
be
r o
f P
ub
lic
ati
on
s
Year of Publication
Total AP
USA
0
200,000
400,000
600,000
800,000
2002 2003 2004 2005 2006 2007 2008 2009 2010 2011
To
tal N
um
be
r o
f P
ub
lic
ati
on
s
Year of Publication
Total AP
USA
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Quality - adherence to best-practice and ethical reporting guidelines
ISMPP AP Webinar 16 Oct 2012
FDAAA
EU Directive
GPP2
CONSORT
PRISMA
STARD STROBE
Etc!!!
IFPMA Disclosure
(AP)
Codes
(AP)
IFPMA Publications
(AP)
EASE
CSE
COPE
WAME
ICMJE
APAME
EMWA ISMPP
AMWA ARCS
(AP) DIA
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How to vote, comment, and ask a question
ISMPP AP Webinar 16 Oct 2012
I can type my question
here – only the facilitator
and speakers can see it
I can type a
comment here - all
attendees will see it
When the poll is
shown here, I can
vote – nobody sees
how I vote
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Poll Practice*
• At this moment, I:
– Have not eaten my lunch
– Am eating my lunch
– Will soon eat my lunch
– Was not even thinking about lunch, but now I feel a bit hungry
ISMPP AP Webinar 16 Oct 2012
* Nobody knows how you vote
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Poll Question 1*
• The average number of conference presentations (eg, slides, posters) that I help prepare per year is:
– Nil
– 1-2
– 3-5
– >5
ISMPP AP Webinar 16 Oct 2012
* Nobody knows how you vote
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Poll Question 2*
• The average number of articles for peer-reviewed journals (eg, manuscripts, reviews) that I help prepare per year is:
– Nil
– 1-2
– 3-5
– >5
ISMPP AP Webinar 16 Oct 2012
* Nobody knows how you vote
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Poll Question 3*
• I have prepared conference presentations or peer-reviewed publications based on
– Non-industry sponsored research
– Industry-sponsored research
– Both types of research
– Not applicable (I don’t prepare these documents)
ISMPP AP Webinar 16 Oct 2012
* Nobody knows how you vote
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Poll Question 4*
• Before this webinar, I had
– Never heard of GPP2
– Heard of GPP2, but not read it
– Read GPP2, but not really used it
– Read and used GPP2
ISMPP AP Webinar 16 Oct 2012
* Nobody knows how you vote
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Disclosures
• Chris GRAF – Member, ISMPP AP Advisory Committee
– Employed by Wiley-Blackwell
• Yuko KOJIMA • Member, ISMPP AP Advisory Committee
• Employed by Eli Lilly
• Karen WOOLLEY (WU Kai-run) • Chairperson, ISMPP AP Advisory Committee
• Trustee, ISMPP
• Employed by ProScribe Medical Communications
• Professor, University Qld, University SC, Australia
ISMPP AP Webinar 16 Oct 2012
In the beginning …
• CBE Retreat: Nov 1998 – Leni Grossman, Merck & Co, organizer
– Journal editors: NEJM, JAMA, Lancet, Annals, etc.
– Industry: Janssen, Lilly, Pfizer, GW, AstraZeneca, etc.
– Academics/Investigators: Cochrane, McMaster, Harvard
– Hot debates • Firewall between medical and marketing
• Role for professional medical writers
• Transparency
• Data ownership and control
Thanks Liz Wager and Betts Field for this slide
The Working Group: GPP1
Volunteers from attendees at CBE Retreat including the following individuals and companies:
• Donna Curtis, Betts Field, Brad Glazer, Leni Grossman, John Tumas, Liz Wager, Erin Walls, Helen Whalley
• AstraZeneca, Eli Lilly, GlaxoWellcome, Janssen-Cilag, Merck & Co., Takeda
• and others …
Thanks Liz Wager and Betts Field for this slide
Publication / promotion: GPP1
• Main publication: CMRO 2003;19:149-54
• 2o publications: MedGenMed, J Br Menopause Soc, Br J Psych
• Letters/ news items: JAMA, Can J Gastroenterol, Ned Tijdschr
• Presentations: CSE, Cochrane, EMWA, EASE
• Website: www.gpp-guidelines.org
Thanks Liz Wager and Betts Field for this slide
1998 seemed a long time ago …
• Trial registration (ICMJE 2004 statement)
• Change in PhRMA position
• Law suits against companies re non-publication
• Industry policies made public
• Other guidelines (EMWA, ISMPP)
• FDAAA
• Results posting
Thanks Liz Wager and Betts Field for this slide
Call for
steering
committee
volunteers
Steering
committee
convened
Structured
review of
GPP1
GPP2
outline
finalized
Global
consultation
announced
Draft
ready
Global
consultation
closed
GPP2
finalized
Place of work Invited
(includes
volunteers)
Agreed
(includes
volunteers)
Commented
Academic center, university 10 4 4
Journal editor 11 8 7
Journal publisher 18 5 2
Medical communication agency,
freelance medical writer 119* 83 52
Pharmaceutical, biotech, or medical
device company 109** 76*** 43
Professional organization 21 17 8
288 193 116
*One email invitation sent but not delivered. **Two email invitations sent but not
delivered. ***One individual lost between invitation and opening of global consultation.
Top 10 Number of
comments
Reimbursement 41
Planning 28
Documentation 24
All authors must critically review and comment on the outline and all
drafts, especially if a medical writer is part of the writing group 22
Disclosures 21
Establish the investigators’ freedom to make public or publish the
study results and their responsibility to avoid premature publication or
release of study information 18
Plagiarism 18
Registering clinical trials 18
Complete and non-duplicative publication 18
Posting clinical trials results 18
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Applying GPP2
in the Asia-Pacific Region
Yuko Kojima
Director
Asia-Pacific Medical Communications
Eli Lilly
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Today’s Topic
• Applying GPP2 in the Asia-Pacific Region: Practical
Examples:
1. Strategic and Ethical Publication Planning
2. Authorship
3. Encoring
• Roles of a Professional Medical Writer (not the same as
a ghostwriter!)
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1. Strategic and Ethical Publication
Planning Why is strategic and ethical publication planning
needed?
• The ultimate goal of experimentation
– To increase the scientific knowledge base through the dissemination of new data and ideas
– Impact and value
–Timely and strategic
–Non-promotional, balanced and scientifically credible way
• The goal of strategic and ethical publication planning
– Balancing customer value with company risk
Customer
Value Company
Risk
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1. Strategic and Ethical Publication
Planning
• What questions do doctors and patients need to have answered
MEDICAL
OBJECTIVE
• The framework for accomplishing the objective
• The boundaries of What, When, and Where
STRATEGY
• The specific disclosures required to accomplish the OBJECTIVE aligned with the STRATEGY
TACTICS
What does a publication plan look like?
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1. Strategic and Ethical Publication
Planning
Who is involved in strategic and ethical
publication planning?
• This is a collaborative process between:
– The lead study physician(s) - owner
– Medical Communications - driver
– Statistics
– Health Outcomes
– Regional/global physicians
– External experts/thought leaders
– Investigators
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2. Authorship
Authorship Criteria
• These are typically shared before and during the study to
reinforce how authorship will be determined and assessed
• All potential authors need to align on roles and
responsibilities (including timing) upfront and to agree on
how to proceed if these expectations are not met
1) Substantial contributions to conception and design, acquisition
of data, or analysis and interpretation of data;
2) Drafting the article or revising it critically for important
intellectual content; and
3) Final approval of the version to be published.
Authors should meet conditions 1, 2, and 3.
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2. Authorship How to successfully engage authors?
• Provide authorship invitations and agreements in local language
(ie, translated from English version into Mandarin or Japanese
versions)
• Use internal contacts who have existing good relationships with
authors for initial contact and follow-up: Physicians, Medical
Liaisons, Clinical Operations
• Allow authors to provide their review comments face-to-face,
phone, email in local language, where possible
• Involve potential external authors as early as possible:
contributions to document scope, analysis plan, etc
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3. Encoring What is encoring?
• Presentation of previously submitted and/or presented work at a new venue with minimal or no changes (eg, translated to local language)
• Usually applied to abstracts and posters
• Helps local doctors access global data
• A low resource intensive and cost-effective way for this region to share key data presented in US/EU with local customers
• Important remarks for timing:
– The original poster must have already been presented
– In general, the encore presentation must be made before any associated manuscript is published, due to journal copyright
• Not always allowed by the congress
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3. Encoring What do we need from the original authors?
• When an encore of abstract / poster / oral presentation is
planned, the original authors are notified.
If all the original authors have no objections, the encore can go ahead.
If any original author has objections that cannot be resolved, then the encore is not possible.
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3. Encoring What if none of the original authors are available to
present at a conference?
• Example 1: A Japanese non-original author may present an encore
of the article that was presented at an international conference
(encore in Japanese)
• Example 2: A Chinese non-original author may present an encore
of the article that was presented at a Japanese conference (encore
in Chinese)
If the congress allows an encore to be given without an original author present, the encore can go ahead
If the congress does not allow non-original author to present the encore, then an encore is not possible.
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Roles of a Professional Medical Writer
Effective
• Driver for strategic and ethical publication planning
Ethical
• Police officer for ethical conduct of publication
Efficient
• Expert on process, standards, and guidelines of publications
Professional Medical Writers
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Agenda
• Welcome
• Introduction and poll questions
• Overview of GPP2
– Chris GRAF
• Applying GPP2 in the Asia-Pacific region
– Yuko KOJIMA
• (Video)
• Questions and, hopefully, answers!
ISMPP AP Webinar 16 Oct 2012
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Reminder…how to ask a question
ISMPP AP Webinar 16 Oct 2012
I can type my question
here – only the facilitator
and speakers can see it
41
FREE video - GPP2 & authorship
• http://www.youtube.com/watch?v=AQdzWDxKajg
ISMPP AP Webinar 16 Oct 2012
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Find out more…www.ismpp.org
• Join your colleagues – join ISMPP
– 50% discount for Asia-Pacific members!
– 12 months $195 only - $95 USD
ISMPP AP Webinar 16 Oct 2012
Thanks to
TransPerfect! (ISO-certified
translators)
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Thank you for attending!
• We hope you enjoyed today's presentation – Please complete a 2-minute survey that ISMPP will
send to you
– Your feedback will help us develop future educational events for the Asia-Pacific region
• Next topics proposed – How Asia-Pacific researchers can increase their
chance of publication success
– How to choose and train a medical writer in the Asia-Pacific region
– 5 things Asia-Pacific editors need to know about publication professionals
– Your suggested topic?
ISMPP AP Webinar 16 Oct 2012
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