optimizing scientific value: smart and systematic ... · publication planning ohave explored common...

11TH ANNUAL MEETING OF ISMPP 1

1 1 T H A N N U A L M E E T I N G O F I S M P P

OPTIMIZING SCIENTIFIC VALUE: SMART AND SYSTEMATIC APPROACHES

TO MEDICAL PUBLICATIONS April 27–29, 2015

Hyatt Regency Crystal City Arlington, VA, USA


REGIONAL CHALLENGES: AGENDA

• Introductions Paul O’Grady (Novartis)

Regional Presentations and Cases: • Europe Rhiannon Meaden (Adelphi)

• Asia Pacific Manon Boisclair (Celgene)

• Japan Paul O’Grady(Novartis)

• Latin America Jorge Moreno Cantu (Merck)

• USA Jill Sanford (Celgene)

• TOV Manon Boisclair (Celgene)


DISCLAIMER

Please note that the views and opinions expressed by the speakers do not necessarily reflect those of Adelphi

Communications, Celgene Corporation, ISMPP, Merck and

Novartis


LEARNING OBJECTIVES

o Better understand the concept of regional publication planning

o Have explored common issues that arise working cross culturally across authors

o Gain insight into practices for working with authors and colleagues in different regions and countries to achieve effective publication planning and execution


REGIONAL CHALLENGES - EUROPE


Rules of the game

• Global standards apply across Europe (e.g. Good Publication Practice)

– Driven by Global Publication Planners – Affiliates may need training/support in

compliance – Investigators often unaware of issues

• Affiliates advise on local regulations

– Travel restrictions for speakers – Sunshine act reporting


Alignment of global and EU plans

• Regional teams repurposing global materials for in-country use

– May jeopardize global activities – May require addition of local authors

• Global agency may be asked to develop

publications for specific markets – Translation generally driven by affiliates – Logistic support may be difficult to provide

Recommendation: Regular meetings to align global and EU plans


Case Study

• Phase 3 data presented at global congress

• Regional team wanted congress data included in national satellite symposium

• NEJM manuscript in preparation. NEJM states that data previously presented at company-sponsored satellite meetings will not be published

• Options: a) Exclude data from national satellite symposium b) Use data from global congress abstract at

national satellite


Case Study 2

Abstract for first disclosure of Phase 2 study rejected by global congress as data not available at time of submission Encore abstract submitted to small national meeting before rejection received ……encore accepted for oral presentation

Possible solutions: a) present data; seek global meeting accepting encores b) withdraw abstract from national meeting c) present only national data, preserving full data for next

global meeting d) present interim data


REGIONAL PUBLICATION PLANNING: ASIA PACIFIC


Background: Journal & Country Ranking

• Increased number of international/local trials with investigators from APAC, especially from China

• Unprecedented number of publications being submitted yearly

Estimated that China might surpass the US by 2020

• Current presence in relation to the publication volume USA is 1st worldwide China is 2nd South Korea is 12th

http://www.scimagojr.com/countryrank.php


Background: Journal & Country Ranking (data from 1996-2013)

http://www.scimagojr.com/countryrank.php


Opportunities & Challenges

• Challenges & current practices: – Gap between current level of awareness &

requirements (optimism) – Local practices (self plagiarism) – Incentives (based on journal prestige & ranking- IF) – Managing expectations in journal choices

(Scholarly vs. open access) – Factors (Promotion, tenure, incentive)

– Delay and timeline to consider when developing publications

• Based on cultural differences, requested review & approval time can be 14-21 days / per draft

• Strict blackouts during religions and civic holidays


Educational Opportunities & Challenges

• Opportunities: – Strong desire to share scientific data (congress,

publications) – Need to further educate:

Shape and sharpen publication planning acumen Dynamic and ever changing environment Increase awareness and knowledge about good

publication practices (GPP2, ICMJE, DOI, copyrights) Requirements (Trial registration outside- local &

international sites) Optimize the choice of appropriate journal selection

– New partners in the region- ISMPP APAC


Roles & Responsibilities • Perception about data dissemination:

– Establishment of a pub steering committee and charter – Publication planning: Involvement and various steps – Before primary data, sub group analysis – Determination of authorship – Good publication practices (ICMJE, GPP2, COI)

• Build solid foundations:

– Beyond cultural and language barriers – Collaborate with the local affiliates and colleagues

(Medical, MSL, clinical, regulatory, HEOR, etc)


Partnership with External Co-Authors • Planning, planning, planning

– Availability &time zone – Pacing down & patience – Meeting face to face, local support

• Sensitivity to cultural and linguistic differences

• Collaboration and scientific input throughout the

publication project

• Globalization – Use of social media and new technology – Translation and increased reach, data dissemination


Case Study- APAC

• A registration phase 3 trial was held in China leading to the first publication “opportunity” for the affiliates and investigators

• Encountered several challenges in relation to: – Timing and development of the various publication

projects (abstracts-> posters-> publications) – Knowledge and acceptance of author order – Understanding of authorship roles & responsibility – Awareness and acceptance of JCME, GPP2,

disclosures – Misconceptions related to journal selection – Trial registration on clinicaltrials.gov


Case Study- APAC

• Developed an educational and action plan which included tactics for the affiliate as well as the external co-authors

– Data availability (DBL, CSR, etc) – Development of a publication plan & timing

(Congress selection, planning for the primary and secondary manuscripts)

– Had several teleconferences to explain roles and responsibilities associated with authorship

– Worked very closely with the clinical team, affiliate and the co-authors to ensure sustained involvement during the various publication projects

– Organized face-to-face meetings to discuss journal differences, and optimal choices as well as for the subgroup analysis


REGIONAL PUBLICATION PLANNING: JAPAN


JAPAN: CONSIDERATIONS

• Japan has a distinct culture – Hierarchical approach in academic research – Formalities are needed in interactions

amongst doctors and publication professionals

• In the pharmaceutical industry, Japan

– Strong regulatory needs – Strong involvement in multinational studies

and many local studies also – Is generally independent of the rest of Asia in

pharmaceutical operations


Japan and Publications

• Publication Professionals in Japan – Within pharma, there are limited publication specific

roles but this is increasing – There are some local agencies – However there are many larger agencies that have

small offices in Japan - the majority of the work is sent back to main offices etc

• Japanese and publications – There is a preference to first publish in English if

possible due to perceived prestige – Japanese specific journals exist in both English,

Japanese and with Japanese articles but with English abstracts

– Japanese congresses are primarily in Japanese but with plenary sessions often at least partially in English


Case Study

• A large multinational study has had primary data presented and published

• A planned updated data set is forthcoming

• Japanese doctor prepares a site specific analysis of patients in the study independent of the sponsor – then notifies publication agency and sponsor

• Plans to submit an abstract to a Japanese congress where the abstract is in English but presentation in Japanese

• Abstract analysis is independently generated but uses data points in the planned updated data

• Japanese congress presentation would occur prior to any potential presentation of the overall updated data set


Case Study 2

• Large international phase III study – Negative at primary endpoint – Steering committee mixed of US, Europe, Asian

doctors • Oral presentation has been completed • Manuscript has been worked on

– Authorship defined up front with steering committee charter and presentation on principles to invesigator

• US steering committee member has led manuscript – At final version sign-off, Asian steering committee

member and co-author rechallenges authorship and data included in the paper

– He claims he has been excluded from manuscript development due to his English language skills


REGIONAL PUBLICATION PLANNING: LATIN AMERICA


Regional Publication Planning: LATIN AMERICA Common Misconceptions

• PEOPLE and CULTURE – LATAM is everything in the American continent outside US/Canada – LATAM countries are essentially the same with similar needs/culture – Most LATAM healthcare providers can read English and have easy

access to English-Language scientific materials

• SCIENTIFIC CONGRESSES – Views on value of scientific congresses similar to those in US/EUCAN – Attendance considered important to stay informed – Regular participation is seen as important for a successful career

• SCIENTIFIC PUBLICATIONS

– Views on value of scientific publications similar to those in US/EUCAN – Adhere to Publish or Perish mentality – Manuscript authorship is essential for a successful career


Regional Publication Planning: LATIN AMERICA Addressing Information and Education Gaps

• CONGRESS PRESENTATIONS

– Local language preferred even when English permitted – Interest in trial results from LATAM subpopulations – Given challenges to participate at international

meetings encore presentations often permitted – Presenter travel support frequently needed – Fees often too onerous for many so participation tends

to be local even when international emphasis sought – Regular congress attendance culture not as well rooted

as in US/EUCAN

Reach tends to be more limited than in international US/EUCAN congresses but still important



• PEER-REVIEWED SCIENTIFIC PUBLICATIONS

– Local language preferred even when English permitted – Interest in results from LATAM subpopulations – Given challenges to access US/EUCAN journals, local,

low-cost, wide-distribution options preferred (only those with University affiliations tend to have access to international journals)

– Publication support frequently needed (i.e., support to cover costs associated with open access, color figures, etc)

– Review-type publications in local-language considered useful Reach tends to be more limited than more didactic

medical education materials but still important



• EDITORIAL SUPPORT and the Role of Publication Professionals

– Knowledge of the role of professional medical writers very limited

– Limited exposure to good publication practices – With exception of international scientific leaders, limited

knowledge of: • Authorship guidelines • The need to separate commercial endeavors from content

development • Guest authorship and Ghost writing • The US and EUCAN legal and regulatory environment

governing publication development

The role of Medical Publication Professionals is largely unknown


Case Study

• A Latin American scientific leader who was an investigator in a

multicenter trial is invited to collaborate in a post hoc analysis exploring the effect of a product in a Latin American subpopulation.

• A kick off call is set up to discuss the data analysis and publication plan.

• The trial sponsor has identified significant information gaps associated with this study and would like to support activities that will disseminate the information in Latin America as efficiently as possible.

• The scientific leader thinks the results are important and recommends submitting the findings to the Lancet because of its impact factor and recognition. He also suggest presenting the results at the largest and most influential congress related to his specialty. This congress takes place in France.

• Challenge: Implement a data dissemination plan to best addresses

the LATAM data information gaps


Case Study 2

• A Latin American scientific leader is invited to

author a paper sponsored by a pharma company. • The author agrees to adhere to ICMJE authorship

guidelines • A kick-off call is set up to discuss the data analysis

and publication plan • The author, although informed about ICMJE

authorship requirements, does not take the guidelines seriously since local companies do not enforce them

• Challenge: Establish a framework that ensures adherence to non-local regulations while respecting local practices.



The Future: • Opportunity for MPPs and ISMPP to play a role • Scientific leaders want to be more engaged • Integration with Global Practices inevitable

• Local Data Generation

– No data no need to publish no writing needs


REGIONAL PUBLICATION PLANNING: US


The US Can Be a Driving Force

• US initiatives can have impact far beyond our borders

– Publication reach is universal – Provides momentum

for global change • Sunshine Act & ToV • Transparency • More stringent journal

requirements

http://www.google.com/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&cad=rja&uact=8&ved=0CAcQjRw&url=http://thebreakthroughconsortium.com/&ei=Yo8JVZLvN4SogwTr9YHwCQ&bvm=bv.88198703,d.eXY&psig=AFQjCNF9ax8iY5VTo93RrK5xXXVJywJ0qA&ust=1426776245431832


Relationship with Global Collaborative & Complementary

• The US publication plan needs to be aligned with Global initiatives

• A collaborative & complementary plan has many benefits:

– Increased consistency – Higher output – Greater reach – Potential cost

savings

http://www.google.com/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&cad=rja&uact=8&ved=0CAcQjRw&url=http://www.lifesciencesindex.com/4750/exostar-and-whoknows-team-to-promote-more-efficient-effective-collaboration&ei=SpcIVbHcI8q0ggS7hYHYBA&bvm=bv.88198703,d.eXY&psig=AFQjCNEsWMM0IBfMibGKIvinp2V1YEulkg&ust=1426712708721100


Considerations for Publication Planning in the US

Transfer of value

Access to primary study data

Extended audience reach

Encore data

Role of review articles


• Approved compound is for the treatment of a disorder that affects multiple body systems. Although there is a primary specialty that “quarterbacks” patient care, there is a tremendous need for education and awareness to many other types of HCPs involved.

• Challenge: Building a publication plan that reaches the tertiary audiences while addressing the complications of:

– Authorship – Cost – HCP travel – Appropriateness of data – Alignment with Global plan

Case: Reaching a Broader Audience

Primary treaters

Nurses

Secondary treaters

Payers

Pharmacists


Case Study 2

• During kick off of a manuscript on a US clinical trial, emails to all authors are circulating to discuss project plan, ICMJE and how to moved forward

• Lead authors have requested editorial assistance

• Co-author after kick off call occurs replies privately requesting no editorial assistance on the project due to TOV and US Sunshine

– What do you do?



TOV


TRANSFER OF VALUE AROUND THE WORLD

• USA: Sunshine Act is a law which came into effect Feb 1st 2013; based on their own interpretation companies can assign a TOV for publication projects.

– Reporting on the CMS site started Sept 30th 2014 http://www.ama-assn.org/ama/pub/advocacy/topics/sunshine-act-and-physician-financial-transparency-reports.page?)

• EU: The EFPIA disclosure code covers 33 EU and other countries

(Switzerland, Russia, etc) & 44 industry partners – Publication projects may have TOV (June 2014) – First reporting will include all events in 2015 and will come into

effect June 2016 http://transparency.efpia.eu/the-efpia-code-2

• Japan: According to the JPMA guidance document medical

writing support for manuscripts has a TOV (as of March 21st 2013)

http://www.jpma.or.jp/english/policies_guidelines/practice.html


TRANSFER OF VALUE AROUND THE WORLD

• ROW: Things can change rapidly in these countries…

Australia

Canada

China

Columbia



Summary


Regional Publication Planning

• Ultimate Goal: Alignment and enhancement of Global plan while still meeting local needs

GLOBAL

REGIONAL

COUNTRY

http://www.google.com/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&cad=rja&uact=8&ved=0CAcQjRw&url=http://uvmbored.com/event/global-internships-information-session/&ei=CaIoVdS7A4GggwTLlYH4Cg&bvm=bv.90491159,d.eXY&psig=AFQjCNGNqZAYEEAOetpx1dOIzeb1jYIl8w&ust=1428812636014391


Key take-aways Established challenges: • Business cultures and protocols

– Cultural sensitivity consistently needed • Language/translation needs • Scheduling/sequencing of publications • Lack of understanding (by colleagues and

authors) of GPP/ICJME – Variable adherence increases the need for MPPs

More dynamic challenges: • Regional, National, International congresses and

journals • Sunshine & TOV • Social media



OPTIMIZING SCIENTIFIC VALUE: SMART AND SYSTEMATIC APPROACHES

TO MEDICAL PUBLICATIONS April 27–29, 2015

Hyatt Regency Crystal City Arlington, VA, USA

optimizing scientific value: smart and systematic ... · publication planning ohave explored common...

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