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2014 European Meeting of ISMPP:
A New Era in Global Medical
Publications
2013: THE YEAR THE SUN SHONE
ON MEDICAL PUBLICATIONS
Alice Choi,
Global Head, CMC, Macclesfield, UK;
Chair-Elect, ISMPP
GENERAL REVIEW OF 2013
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AUGUST 1 2 3 4 5 6
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SEPTEMBER 1
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OCTOBER 1 2 3 4 5 6
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DECEMBER 1
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WHAT WILL 2014 BRING??
TRANSPARENCY, PUBLICATION
AND THE PATIENT 2013
Professor Finbarr Cotter
Barts Health NHS Trust, Queen Mary University of London
Improving expectations
Bringing the patient into the partnership
The HRA interest in good research conduct
May 2013- Transparent research
• Trial registration
• Publication and dissemination of research results
• Access to data
• Access to tissue
• Providing information to participants at the end of the study
NHS England increased openness and transparency 31 October 2013 – HQIP (Health quality improvement partnership)
• Publishing more clinician level data
• Publishing more overarching clinical indicators
• Extending the Friends and Family Test
• Linking clinical data from GPs
• DANGER: EU DATA PROTECTION LAW
REVISION
NHS England increased openness and transparency 31 October 2013 – HQIP (Health quality improvement partnership)
• “Greater transparency will empower patients and citizens to hold the
health service to account and at the same time support life sciences
research so that more life-saving treatments can be found.’’
• “I am delighted to announce further ground-breaking commitments to
making the NHS first for patients, enterprise and science.’’
• “No country in the world has made such commitments to giving patients
a voice so that their services can be improved.”
What is the Health and Social Care Information
Centre doing?
We recognise the huge opportunities that central
open data brings in:
• increasing patient choice
• improving patient outcomes
• delivering increased productivity
• contributing to the economic growth agenda
US Sunshine Act Aug 1st 2013
• Greater transparency of Physician/Pharma payments
Transparency: Journals
• Agreement to publish EMA data in paper
• Understand the value of the negative
• Availability to the patient
Openness and transparency
Prof Finbarr E Cotter
Barts Health Heamato-Oncologist
“questions”
2014 European Meeting of ISMPP:
A New Era in Global Medical
Publications
2013: NEW DEVELOPMENTS IN
PUBLISHING
Rebecca Lawrence, PhD
Managing Director, F1000 Research Ltd, London, UK
@RNL_S | @F1000RESEARCH
@rnl_s | @f1000research
F1000RESEARCH: WHO ARE WE? OPEN SCIENCE JOURNAL IN LIFE SCIENCE
• No delay.
• Invited post-publication peer review.
• Open refereeing.
• Inclusion of all data.
• No restriction of access.
• All article types published.
@rnl_s | @f1000research
• New Open Access payment models: PeerJ, eLife
• Separating peer review: Rubriq, PubPeer, Peerage of Science
• Post-publication commenting: PubMed Commons, Publons, Libre
• Preprint servers: PeerJ PrePrints, BiorXiv
• New data journals: Scientific Data
• Open Science publishing: F1000Research
• Reproducibility: ScienceXchange–PLOS collaboration
• ALMs: Altmetric.com, Impact Story, Plum Analytics, F1000Prime, data
metrics to come
2013: START OF A NEW ERA IN PUBLISHING?
@rnl_s | @f1000research
DATA TRANSPARENCY: WHAT IS BEING DONE BY
PUBLISHERS?
Long list of publishers signed in support of AllTrials campaign e.g. BMJ, PLOS, BMC, Royal Society of Medicine, SAGE, Wiley, F1000Research, eLife, PeerJ
Easy to sign, has helped raise awareness, but much harder to really change things
However, publishers are largely keen to:
• Advocate and influence government policy and legislation in Europe to move
towards the ideas behind the AllTrials campaign
• Support the idea of publishing all results, irrespective
of outcome (e.g. RIAT)
o F1000Research did a 4-month campaign in 2013
to offer free publication for any negative/null results
Generated a huge amount of support
But hard to get people to submit
OTHER CHALLENGES IN PUBLISHING DATA
@rnl_s | @f1000research
• How and where to store the data (repository accreditation)
• How to safeguard data protection and ensure appropriate access
• How and who curates it to make it useable by others?
• What data to include?
• Who pays for data storage?
• How to peer review data?
@rnl_s | @f1000research
MOVING BEYOND JUST LINKS TO DATA
Elsevier PDB and GEO links
F1000Research All data with viewers
PLOS Supplementary files
@rnl_s | @f1000research
A fixed-dose randomized controlled trial of
olanzapine for psychosis in Parkinson disease
[v1; ref status: indexed, http://f1000r.es/1au]
Michelle J Nichols, Johanna M Hartlein, Meredith
GA Eicken, Brad A Racette, Kevin J Black
F1000Research 2013, 2:150
IN-ARTICLE DATA MANIPULATION
@rnl_s | @f1000research
• We need a shift in the incentivisation systems to redress the
publication bias
• Much greater data transparency
• Articles should become living objects, just like research
• Data as the primary object: publications are data/protocol;
analysis, discussion, conjecture are additional elements
• A few megajournals/repositories rather than thousands of
individual journals
WHERE ARE WE HEADING?
PUBLICATIONS:
PFIZER’S IMPLEMENTATION OF
THE US SUNSHINE ACT
REPORTING REQUIREMENTS
Lorna Fay
Senior Director, Publications Team, Pfizer, New York, USA
DISCLOSURES
Lorna Fay is an employee of Pfizer. The views and opinions presented
here during discussion are her own and may not represent those of her
employer.
SUNSHINE ACT: IN-SCOPE
• Direct Payment
• Payment to authors who are covered recipients for the development of
a publication for a submission to a scientific journal or presentation at
a scientific congress
• Covered recipient – physicians (MD, DO, DDS, DPM, OD, DCP)
licensed in the US
• Transfer of Value (TOV)
• Editorial/medical writing support provided to authors who are covered
recipients for any publication developed for submission to a scientific
journal or presentation at a scientific congress
• Publication Agency
• Pfizer employee (non-author)
*
SUNSHINE ACT: PFIZER’S
ASSUMPTIONS FOR TOV
• Value of editorial/medical writing support
• The value varies according to
• Type of deliverable (eg, abstract, manuscript) and level of support
(eg’ edit from copy. resubmission)
• Assignment to authors
• If there are multiple authors, each author is assigned the same value
• Fair market value approach
• For each deliverable and level of support
• FMV per author= average cost of editorial/writing support
average number of authors
*
SUNSHINE ACT: PFIZER’S
ASSUMPTIONS FOR TOV
• Date of transfer of value
• Abstracts/manuscripts
• Date of submission to congress/journal
• Posters/oral presentations
• Last day of congress
*
SUNSHINE ACT: IMPLEMENTATION
• Editorial/writing support
• Before writing starts, authors must agree (document decision)
• Data collection (Datavision)
• Covered recipients’ information eg name, organization,
credentials, NPI #, etc
• Level of service (budget module)
• Data reporting
• Extract from Datavision forwarded to Pfizer’s transparency group
for reporting
SUNSHINE ACT: AUTHORS’
QUESTIONS
• Am I required to accept editorial support?
• If I decline editorial support, will I be removed as an author?
• How did Pfizer calculate FMV?
• Assigning the cost of editorial support equally to all authors makes no
sense. Shouldn’t the cost be assigned in proportion to the
responsibilities and academic credit?
• Are physician-authors based outside of the US in-scope for disclosure
of editorial support? Why am I receiving communications regarding
the Sunshine Act?
• If a co-author prepares the manuscript is there. a transfer of value to
the other authors?
SUNSHINE ACT: AUTHORS’
QUESTIONS
• Does TOV count toward the total institutional pharma cap
that many institutions have for their HCPs?
• How will the TOV be displayed on the CMS website?
SUNSHINE ACT: PUBLICATION
TEAMS’ QUESTIONS
• Is there a TOV for encore congress deliverables?
• Are Open Access, journal page fees, etc included in the TOV
calculation?
• Are physician-authors employed by a co-development partner
in-scope for disclosure for editorial support?
• Are US-licensed physicians employed as contingent workers
subject to disclosure?
• If an author is a US-licensed physician and a former Pfizer
employee, but now works for another company, are they subject
to disclosure?
