Medical writing in clinical research

MEDICAL WRITING IN CLINICAL RESEARCH
Presented by
Patel Hemangini P. (Roll no-14)
M.Sc. In Clinical Research (Sem-II)

CONTENT :
 Introduction
 Medical Writers
 Type of medical writing in clinical research
 Diffrence between Medical writing and Scientific writing
 Requirements for becoming a Medical writer
 What makes a good Medical writer?
 Steps in writing scientific documents
 Do’s & Don’t of Medical writing
 Medical Writing Organizations
Clinical Research Programs, Gujarat University
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INTRODUCTION
 Medical Writing is the activity of producing scientific documentation by
a specialized Writer.
 Medical Writing deals with developing clinical and scientific
documentation in a standard, comprehensive, reliable, skilled and
convincing manner.
 Medical Writing is an art of writing about a particular content more
efficiently and clearly that target audience can simply be understood.
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MEDICAL WRITERS
 The medical writer typically is not one of the scientists or doctors who
performed the research.
 A medical does not necessarily have to be a medical person by qualification
however some degree of familiarity with medical terms is preferable.
 Medical Writers are professionals with a broad expertise in communication,
who are skilled at presenting complex information in a manner that is clear,
logical, and attuned to the needs of a particular audience.
 Medical Writers often have formal training in Science, which provides a
solid foundation for gathering and evaluating medical information.
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CONT…
 They understand ethical standards and contribute a wide range of skills in
project planning and management.
 Medical Writers ensure that the documents that they write comply with all
regulations and guidelines in terms of content, format and structure.
 Altogether, the skill of a medical writer contribute to improving each team
they support.
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CONT…
 Doctors, people who conducted the research, Statisticians, regulatory
professionals and other subject matter experts work hand in hand with
medical Writers to produce documents that are of highest quality and
meet all the applicable regulatory requirements.
 Medical Writers ensure that the documents that they write comply with
all regulations and guidelines in terms of content, format and structure.
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TYPES OF MEDICAL WRITING IN CLINICAL RESEARCH
 Normally, medical writing in pharmaceuticals industry can be sub
divided into three broad categories.
1. Regulatory Medical Writing
2. Educational Medical Writing
3. Medico- marketing Writing
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REGULATORY MEDICAL WRITING
 As the name suggests, deals in writing documents related to regulatory
authorities.
 E.g. FDA, EMEA, DCGI etc.
 These can include documents related submission for receiving approval
for conducting new clinical trials, submission documents for obtaining
approval for marketing a drug, device or biologic etc.
 Mainly regulatory writing will consist of writing clinical study
protocols, clinical study reports, informed consent forms, investigator
brochures etc.
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Cont…
 Writing of these documents has to follow important regulations and
guidelines as applicable.
These documents in general discuss the data a company gathers in the
course of developing a medical product.
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EDUCATIONAL MEDICAL WRITING
 As the name suggests deals with writing educational content for a particular
audience.
 The audience for example can be health practitioners or the general lay public.
 Educational medical writing in general consists of writing literature about
newly launched products, making presentations for various conferences and
meetings etc.
 It include investigator summaries, publication plans, abstracts, slide posters,
manuscripts, advisory board reports, website content and patients information.
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Cont…
 This provides great opportunity to medical writers to work as
freelancers for multiple companies at the same time.
 Most large companies usually have in-house medical writers to do this
job; however may companies prefer to outsource this work to skilled
medical writers.
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MEDICO- MARKETING (MEDICALAFFAIRS) WRITING
 Medical- marketing (medical Affairs) writing involves developing
marketing material for ethical promotion of a therapeutic product.
 The documents may include product monographs, training materials for
the sales force, reference compendium, patient information leaflets
(PILs), CME slides, leave behind leaflets (LBLs) etc.
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DIFFRENCE BETWEEN MEDICAL WRITING AND SCIENTIFIC
WRITING
 Medical Writing is a much more specialized area of scientific writing is writing
about science regardless of whether it is about medicine, chemistry, physics etc.
 Thus, all medical writers are science writers are science writers while all science
writers are not medical writers.
 For example if you draw two concentric circles, one larger than the other.
 The larger one represents scientific writing and the smaller (inner) circle
signifies medical writing.
 Scientific writing includes all writing that deal with science such as medicine,
chemistry, biology physics and etc and medical writing is about writing on
subject associated to health & medicine.
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REQUIRMENTS FOR BECOMING A MEDICAL WRITER
 The basic pre- requisite for becoming a medical writer is of course,
familiarly with medical concepts and terminology.
 An academic qualification in one of the life sciences such as medicine,
or paramedical sciences such as pharmacy, microbiology, nutrition and
dietetics, biochemistry, biotechnology can provide the right background
which makes the writer familiar with scientific concepts and research
data.
 Another important pre- requisite is the ability to write.
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Cont…
 As the basic requirement on the part of a medical writer is to
communicate scientific audience, some degree of command over the
language, reflected by an ability to write grammatically correct text, and
ability to express and present information clearly and succinctly is most
important.
 In addition to the have basic requirements, one needs domain knowledge
& language skill.
Clinical Research Programs, Gujarat University 15

WHAT MAKES A GOOD MEDICAL WRITER?
 Ability to understand the purpose and requirements of the project
 Ability to write at a level appropriate to the target audience
 Thorough research of a subject
 Ability to think, logical organization on thoughts and ideas
 Scientific accuracy
 Attention to details
 Ability to work across teams as well as independently
 Good communication & coordination with various people involved in the process
 Good time management, and deadlines and commitments
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STEPS IN WRITING SCIENTIFIC DOCUMENTS
 Understanding the project brief
 Literature search & review of information
 Authoring & compiling the document
 The review process
 Formatting & editing
 Approval and sign off
 Electronic publishing
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DO’S AND DON’T OF MEDICAL WRITING
DO’S
 Let the writer know if you will be on
vacation or unavailable for a period of
time
 Provide text as requested (by deadline)
 Keep the writer informed of any
changes to the programme that might
affect the document
 Provide actionable comments
 Provide specific reference and source
documents
DON’T
 Ignore questions or forget to respond
to the medical writer
 Send multiple version s of a
document to the entire team; this can
lead to version control issue
 Focus on minor wording issues and
miss the “big picture”
 Skip comment review meetings
 Wait until the final draft to actually
read the document
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MEDICAL WRITING ORGANIZATIONS
 American Medical Writers Association (AMWA)
 Australian Medical Writers Association (AMWA)
 European Medical Writers Association (EMWA)
 Indian Medical Writers Association (IMWA)
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REFERENCES
1. http://www.ncbi.nlm.nih.gov
2. www.jli.edu.in
3. http://www.jliedu.com
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Medical writing in clinical research

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