Ghost writers

Transcription

Ghost writers
Thank you for joining ISMPP U today!
The program will begin
promptly at 11:00 am EST
ISMPP would like to thank…
the following Platinum Sponsors for their
ongoing support of the society
Today’s Program
• Presenter
 Chris Graf, Wiley-Blackwell
• Moderator
 Beth Young, PhD, CMPP
• Q&A follows the presentation−but feel free to
send in questions as you have them
GPP2
Chris Graf
Wiley-Blackwell, Associate Editorial Director
Publisher, International Journal of Clinical Practice
chris.graf@wiley.com
+44 1865 476 393
GPP2 Steering Committee
•
Wendy Battisti, Johnson & Johnson
•
James Gurr, Pfizer
•
Dan Bridges, Excerpta Medica, Elsevier
•
Mary-Ellen Marx, PharmaWrite
•
Victoria Bruce-Winkler, Dunblane, UK
•
Jane Moore, Medtronic
•
Joanne Conaty, AstraZeneca
•
Mina Patel, Cephalon
•
John Draper, Peloton Advantage
•
Carol Sanes-Miller, AstraZeneca
•
John Ellison, LifeScan
•
Yvonne Yarker, KnowledgePoint360
•
Elizabeth Field, Field Advantage Medical
Communications
•
And me…
Disclosure
•
Disclosures for Chris Graf: Lead author GPP2; Board member of ISMPP; Council member
of COPE
Disclaimer
•
The opinions expressed here do not necessarily represent those of the authors’ employers
•
Role of the sponsor, contributions, acknowledgements, funding, disclosures of competing
interest for all authors are described in detail in BMJ 2009;339:b4330
BMJ 2009;339:b4330
gpp-guidelines.org
http://www.flickr.com/photos/its-only-lines/361847312/
BMJ 2009;339:b4330
116 comments on first draft
Professional
organisation
Academic centre or
university
Journal
editor
Drug, medical
device, or
biotechnology
company
Journal publisher
Medical
communication
agency, freelance
medical writer
What’s new, updated?
• Lead author, guarantor, publication
steering committee, medical writers
• Reimbursement, honoraria
• Publication planning, documentation
• Defining roles, including sponsor’s
• Checklists
Too much to cover, so…
• Publication steering committees
• Authors
• Professional medical writers
• Publication planning
Publication steering committee
• It may be useful to form a publication
steering committee
… of authors and contributors
… to oversee and produce articles and
presentations from a research study
Publication steering committee
• Members of the study steering committee
and the protocol development team
• and…
Publication steering committee
• Investigators and other individuals who
have expertise in the area and who are
willing to interpret the data and write or
review articles and presentations
• and…
Publication steering committee
• Employees of, or contributors contracted
by, the sponsor company who are involved
in the study
… (for example, clinicians, statisticians, or
professional medical writers)
Publication steering committee
• We recommend that…
• It should be formed early (when the
protocol is finalised or at end of enrolment)
• All investigators know about its
membership, responsibilities
• Authors, contributors agree to their roles
before writing begins
http://www.flickr.com/photos/icedsoul/3032507196/
Authors
• We recommend using the criteria for
authorship described in the ICMJE
“Uniform Requirements”
Authors
• ICMJE criteria allow assignment of
authorship to individuals who have
contributed to the analysis and
interpretation of a study
…but who may not have contributed to its
conception and design
Authors
• We recommend that authorship criteria are
applied consistently to all contributors to
an article or presentation
… including investigators, sponsor
employees, and individuals contracted by
the sponsor
Authors
• Before writing begins one author (“lead
author” who may also be “guarantor”)
should take the lead for writing and
managing each publication or presentation
• One author (“guarantor”) should take
overall responsibility for the integrity of a
study and its report
Authors, all contributors
• We recommend that clear, concise
descriptions of the role performed by each
contributor during preparation of the article
or presentation (including but not limited to
the authors) are made
http://www.flickr.com/photos/gpayne85/3542928915/
Professional medical writers
• Professional medical writers should
ensure that authors control and direct
writing
… and that disclosures of funding,
potential conflicts of interest and
acknowledgement of contributions are
made
Professional medical writers
• Professional medical writers must be
directed by the lead author from the
earliest possible stage
… and all authors must be aware of the
medical writer’s involvement
Professional medical writers
• The authors must critically review and
comment on the outline and drafts
… approve the final version of the article
or presentation before it is submitted
… approve changes made during the
peer-review process
… approve the final version before it is
published or accepted for presentation
Professional medical writers
• Professional medical writers, depending
on the contributions they make, may
qualify for authorship
• We recommend that particular care is
taken to ensure appropriate
acknowledgement of the contributions
made by medical writers and to describe
their funding
Professional medical writers
• We recommend authors, professional
medical writers use a published checklist
to discourage ghostwriting
http://www.flickr.com/photos/seven13avenue/2355963809/
Publication planning
• We recommend that companies, and the
organisations or individuals working for
them, document how publications are
initiated and developed
Publication planning
• A publication plan should support authors
and publication steering committees
… in their efforts to ensure appropriate,
efficient, and complete communication of
results
Publication planning
• Identifying submission deadlines for
relevant congresses
• Determining which studies are appropriate
to present and might have data available
• Identifying areas for new publications
(sub-group analyses, topics for pooled
data analyses, post hoc analyses,
systematic reviews)
Publication planning
• Identifying the resources required, such as
statistical analyses
• Avoiding premature release of results
• Avoiding duplicate publication
Documentation
• We recommend that companies
implement policies detailing the types of
documentation to be retained
Documentation
• Agreements to participate
• Details of intellectual input, direction, and
contributions
• Main versions of the draft
• Workflow, timelines
• Approval from authors
• Lists of who reviewed or commented
Checklists
• GPP2 checklist for articles and
presentations
• GPP2 checklist of basic requirements for
written publication agreements
• Too big for here… check them in the
actual article
http://www.flickr.com/photos/toechsner/2882757624/
Questions & Answers
To ask a question, please type your
query into the ‘Q&A’ chat box at the
bottom left of your screen. Every attempt
will be made to answer all questions.
Next ISMPP U
DATE:
January 13th
TIME:
11am EST
TOPIC: CMPP Primer: What You Need to Know
Thank you for attending!
We hope you enjoyed today’s presentation.
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