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

JANUARY 1 2 3 4 5 6

7 8 9 10 11 12 13

14 15 16 17 18 19 20

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28 29 30 31

FEBRUARY 1 2 3

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MARCH 1 2 3

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18 19 20 21 22 23 24

25 26 27 28 29 30 31

MAY 1 2 3 4 5

6 7 8 9 10 11 12

13 14 15 16 17 18 19

20 21 22 23 24 25 26

27 28 29 30 31

JUNE 1 2

3 4 5 6 7 8 9

10 11 12 13 14 15 16

17 18 19 20 21 22 23

24 25 26 27 28 29 30

JULY 1 2 3 4 5 6 7

8 9 10 11 12 13 14

15 16 17 18 19 20 21

22 23 24 25 26 27 28

29 30 31

AUGUST 1 2 3 4 5 6

7 8 9 10 11 12 13

14 15 16 17 18 19 20

21 22 23 24 25 26 27

28 29 30 31

SEPTEMBER 1

2 3 4 5 6 7 8

9 10 11 12 13 14 15

16 17 18 19 20 21 22

23 24 25 26 27 28 29

30

OCTOBER 1 2 3 4 5 6

7 8 9 10 11 12 13

14 15 16 17 18 19 20

21 22 23 24 25 26 27

28 29 30 31

DECEMBER 1

2 3 4 5 6 7 8

9 10 11 12 13 14 15

16 17 18 19 20 21 22

23 24 25 26 27 28 29

30 31

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?

@rnl_s | @f1000research

Thank you!

rebecca.lawrence@f1000.com @rnl_s | @f1000research

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?