Good Publication Practice 2 in the Asia-Pacific region

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


4

International Society for Medical Publication Professionals


• 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!


6

ww

w.b

erg

oia

ta.c

om

C

red

it: w

ww

.be

rgo

iata

.co

m

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

8

Quality - adherence to best-practice and ethical reporting guidelines


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

9

How to vote, comment, and ask a question


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

10

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


* Nobody knows how you vote

11

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



12

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



13

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)



14

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



15

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


Chris Graf Editorial Director, Wiley-Blackwell

[email protected]

GPP2

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 …


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


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


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

BMJ 2009;339:b4330

• November 2009

• gpp-guidelines.org

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

26

Applying GPP2

in the Asia-Pacific Region

Yuko Kojima

Director

Asia-Pacific Medical Communications

Eli Lilly

27

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!)

28

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

29


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?

30


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

31

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.

32

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

33

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

34

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.

35

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.

36

Roles of a Professional

Medical Writer

37

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

38

39

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!


40

Reminder…how to ask a question


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


42

Questions?


Cre

dit:

Duke

-NU

S 2

007

43

Find out more…www.ismpp.org

• Join your colleagues – join ISMPP

– 50% discount for Asia-Pacific members!

– 12 months $195 only - $95 USD


Thanks to

TransPerfect! (ISO-certified

translators)

44

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?


Documents

Good Publication Practice 2 in the Asia-Pacific region