fda – center for drug evaluation & research puzzling publication process made painless lcdr...
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FDA – Center for Drug Evaluation & Research
Puzzling Publication Process Made Painless
LCDR Melinda McLawhorn, PharmD, BCPS
Gilbert Burckart, PharmD FCCP
FDA – Center for Drug Evaluation & Research
Overview
• Introductions• What and Where have PHS Pharmacists
Published?– LCDR McLawhorn
• Getting Published in the Medical/ Pharmacy Literature– Dr Burckart
• Question and Answer– Dr Burckart
FDA – Center for Drug Evaluation & Research
What do PHS Pharmacists publish?
• Search of PubMed and EBSCOHOST– Over 85 PHS publications– Over 20 publications by PHS Pharmacists
or related to Pharmacy profession in PHS– Countless other publications by PHS
Pharmacists on scientific topics– difficult to abstract by author affiliation
FDA – Center for Drug Evaluation & Research
FDA – Center for Drug Evaluation & Research
What do PHS Pharmacists publish?
• Most Common topics of PHS Pharmacists Publications*:– Roles of PHS Pharmacists in Healthcare
System (15)• Career Opportunities for Pharmacists• PHS Pharmacists contributions to
pharmaceutical care
– Roles of PHS Pharmacists during Deployment (6)
*Does not include scientific publications by PHS Pharmacists on scientific topics
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• Most common journals with PHS Pharmacists publications:– American Journal of Health System
Pharmacists (5)– Military Medicine (3)– Journal of the American Pharmacists
Association (3)– Hospital Formulary (2)
Where do PHS Pharmacists Publish?
FDA – Center for Drug Evaluation & Research
• Other journals with PHS Pharmacists publications:– Drug Topics– Journal of the Royal Society of Health – Drug intelligence & clinical pharmacy– NEWS-Line for Pharmacists – Officer– Pharmacotherapy– Pharmacy in History
Where do PHS Pharmacists Publish?
FDA – Center for Drug Evaluation & Research
Gil Burckart, Pharm.D.
Associate Director
Office of Clinical Pharmacology
Office of Translational Sciences
Getting Published in the Medical/Pharmacy Literature
FDA – Center for Drug Evaluation & Research
Why publish?
• Getting information out is our public health imperative– The evaluation of new services is critically important;– Analysis (reviews, meta analysis) of current practices
contributes to better health care;– Provides transparency for decisions that are made.
• Advances our service and our profession• Provides the opportunity for personal growth and
recognition
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Outline
• The idea
• The background
• The nuts and bolts of putting the article together
• Selecting a journal
• The review process
• Things considered bad behavior by authors
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The IDEA
• Write about what you know and have a passion for– This doesn’t mean that you have to be an “expert” in
the area;– This may be an area that you WANT to get to know
better;• There is no better way to learn a subject than to have to
teach it to someone else
– Having an assessment or evaluation tool is good, but sometimes a descriptive piece is all that is needed.
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Picking a format
• Case studies
• Review articles
• Research Evaluation
• Descriptive report
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The Background
• This can be the toughest part, so don’t skimp on the amount of time that you put into this!– You have to know what other people have
written in the subject area to be able to put your manuscript in context.
– Organization of this material is critical to being able to use it appropriately in your manuscript.
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Putting the article togetherStep 1
Make a brief outline
I. Introduction
II. Methods
III. Results
IV. Discussion
References
Tables, Figure captions, Figures
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Putting the article togetherStep 2
Co – Authors• Choose co-authors carefully.• Can they add a real contribution to some aspect
of the manuscript?• In some cases, you may want to collaborate
from the outset with a very experienced author who is willing to mentor you through the process of your first manuscript.
• 1st author and last author?
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Who is an Author?• A person designated as an author must meet all of
the following criteria: (1) contributed to the conception and design, or analyzed and interpreted the data; (2) drafted the article or revised it critically for important intellectual content; and (3) approved the final version to be published.*
• Supporting the study or collecting data does not constitute authorship. Authorship based solely on position (e.g., research supervisor, department chair) is not permitted. Any person not meeting all three criteria above should be listed in an acknowledgment.
*From the International Committee of Medical Journal Editors
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Authorship forms:
If you have any questions about authorship (BEFORE asking someone to co-author with you), just read the JAMA authorship responsibility form and it will become obvious.
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Role of the Corresponding Author
“The corresponding author (or coauthor designee) will serve on behalf of all coauthors as the primary correspondent with the editorial office during the submission and review process. If the manuscript is accepted, the corresponding author will review an edited typescript and proof, make decisions regarding release of information in the manuscript to the news media, federal agencies, or both, and will be identified as the corresponding author in the published article. The corresponding author is responsible for ensuring that the Acknowledgment section of the manuscript is complete. “Acknowledgment” is the general term for the list of contributions, disclosures, credits, and other information included at the end of the text of a manuscript but before the references. The corresponding author is responsible for ensuring that the conflict of interest disclosures reported in the Acknowledgment section of the manuscript are accurate, up-to-date, and consistent with the information provided in each author’s.”*
*JAMA Instructions for Authorshttp://jama.jamanetwork.com/public/InstructionsForAuthors.aspx
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Putting the article togetherStep 3
Start writing!• Take the sections that are obvious and write
them first– For example, the “Methods” and the “Results” are
often straightforward, so write them first.
• The Pareto principle or the 80–20 rule is at work. It commonly takes 20% of the full time to complete 80% of a task while the last 20% takes 80% of the effort.– Those final edits will be slow, so get 80% of the task
done quickly.
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Plan Ahead!
• If you will need:– Figures to be professionally drawn;– Articles via interlibrary loan;– Permissions from a list of supervisors.
• Then, plan ahead and start that work early.
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Detailed Outline
• If you need it, especially for the Discussion, make a detailed outline of the paragraph by paragragh points that you would like to make;
• Should provide the reader with a logical progression of evidence from your manuscript, to previously reported data, to the conclusion that you have drawn.
FDA – Center for Drug Evaluation & Research
Using the technology available
• Entering references is easy if you know how to (1) dump references from your literature search into a reference database, (2) know how to insert references from your database into your text, and (3) know how to reformat your bibliography using the software.
• EndNote and Reference Manager are the two most popular reference database software programs.
• Makes editing and moving a different journal painless!
FDA – Center for Drug Evaluation & Research
Putting the article togetherStep 4
Choosing a journal• Choose a journal which targets your audience of
interest;• Select a journal which publishes articles much
like the one that you want to publish;• Watch for fees!
– They can vary considerably, but may be waived for submissions from governmental agencies;
– When in doubt, call or write and ask.
FDA – Center for Drug Evaluation & Research
A Journal’s Impact Factor
• What is “Impact Factor”?
• Is the Impact Factor important to me?
• Shouldn’t I always try for the best journal?
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The Journal
• Most journals provide a detailed checklist of:– Format (font size, margins)– Title page information (listing of authors and
affiliations, corresponding author, Keywords, running title, abbreviations
– Table (generally do not use the MS Word table maker)
– Figures (TIFF file or other specification)
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When do I have to obtain permission to use tables or figures
from another publication?
• Basically, “data” are not protected by copyright. As a result, most tables (which are classified as “data”) do not require permission. You must, however, give credit to the original source.
• Figures that can only be portrayed in one or a very few formats (e.g., the diagram of the dermatomes, the Kreb’s cycle, a porin structure, chemical structures) do not require permission.
• Truly unique figures (works of art) require permission.
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Putting the article togetherStep 5
Final editing and submission• Do not rush this step.• Carefully make your final edits, and try to
view the manuscript the way a reviewer would.
• Sloppiness (numbers that don’t match, spelling errors, not following instructions) tells the editor and reviewer that the research may be sloppy too!
FDA – Center for Drug Evaluation & Research
How to maximize the chance that your paper will make it to the reviewers:
Follow the instructions for authors.• Got questions? Call the journal.• Have a smart colleague who is not involved with
your paper proof your submission before submitting it.
• Use your spellchecker for the manuscript AND the cover letter.
• Ensure that the names of the editor and the journal are correct in your cover letter.
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The Life of a ManuscriptAuthor
EditorAssociate Editor
EditorialBoard
Reader
Reviewers
Society
New Knowledge
ScientificEditors
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Reviewers
•Who are they?
•How are they selected for a particular paper?
•How are their comments weighted by the editor?
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What I look for in reviewing a manuscript
• Objective – clearly stated at the end of the Introduction– Is it worthwhile? Does it follow through the whole
manuscript?• Methods – detailed enough to clearly understand
what was done• Results – organized with Figures and Tables
that really assist the reader to understand the results
• Discussion and conclusion – practical; states limitations; does NOT overstate the conclusion in relation to what the study showed
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Learn to become an expert reviewer who
is indispensable to the journal
• Why great reviewers are often great writers• Learn from expert “mentor” reviewers in your
area• Set limits (especially in the beginning)• Meet deadlines! Your reviewer history will
follow you forever.• Ask for sample “very good” reviews, not “the
best reviews ever.”
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The Editor’s letter to the author:“Accept with revision”
• Follow the “requests for revision” precisely (e.g., provide your response to each highlighted reviewers’ comment).
• Call the editor with any questions or issues.
• Revision due dates: These are usually “serving suggestions” rather than drop-dead dates. Call the editor if you need more time.
FDA – Center for Drug Evaluation & Research
The Editor’s letter to the author:“Reject”
• It should detail precisely why your manuscript was rejected. It may be that your paper just did not hit a high enough “priority score.”
• Call the editor to clarify any questions.• If perceived “fatal flaws” can be corrected, inquire as
to whether this could change the status of your paper to “Could be acceptable pending extensive revisions.”
• Do not abuse the above maneuver. There is a fine but distinct line between your ability to argue that you can provide the critical missing data and whining.
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“Kiss of Death” Maneuvers
• Simultaneous submission to more than one journal
• “Salami science” submissions
• Plagiarism or “creative lifts” from other publications
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“Ghost” Authors• “Ghost” authorship is defined as a person or entity
contributing substantially to the creation of a manuscript (as defined above), but who is not acknowledged as an author. This situation most often arises when a commercial entity (e.g., a medical education company acting on behalf of a pharmaceutical manufacturer) actually creates the first or subsequent drafts of a manuscript.
• The ethical breach here is that an actual author is missing from the list of authors. The remedy is to reveal all “real” authors to the readers, as well as their affiliations.
FDA – Center for Drug Evaluation & Research
“Guest” Authors
• “Guest” authorship occurs when a “ghost” author truly creates a manuscript, and invites the “guest” author to be named as the author, with little or no intellectual input to the manuscript from the guest author.
• Guest authorship in this context is never ethical.
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Concluding remarks
• Writers are not born; they are created by working at writing;
• Writing fulfills an important public health mission and should be supported by government health agencies;
• Opportunities to write about important issues are all around us, so we just have to be mindful of those opportunities.
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References and Suggested Reading
Strunk W, White EB. Elements of style. New York: Macmillan Publishing Company (obtain most recent edition).
Huth EJ. Writing and publishing in medicine. Philadelphia: Williams and Wilkins, 1999.
Day RA. How to write and publish a scientific paper. Philadelphia: ISI Press, 1979.
Sylvia LM, Herbal JL. Manuscript peer review--a guide for health care professionals. Pharmacotherapy 2001;21:395-404.
Neill US. How to write a scientific masterpiece. J Clin Investigation 2007;117:3599-3602.
Thanks to Dr. Rick Scheife, Editor of the journal Pharmacotherapy, for sharing some of his slides related to this topic.