Transcript How to leave the bench

Drug development
and the scribe
Dr Christine McKillop
Medscimedia Ltd
The route I took
BSc: Bacteriology/Virology
 PhD: Colo-rectal cancer
 Seven years post-doc in biotech
industry: genome mapping
 Editing/writing: in-house 1 year
 Specialisation:
Urology/Oncology/Dermatology
 Medical writing course: EAU
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Phase I
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Establishes safety in humans
Patient population is a limited group of
healthy volunteers (20–40)
The studies are used to determine:
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toxicity
dosages (formulations and amounts)
blood levels
excretion profiles
pharmacokinetic profiles
Phase II
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These studies are used to determine:
 toxicity
 compatibility with other medications
 bioavailability/bioequivalence of different formulations
 plus a variety of other effects.
Generally when adverse effects of a potential drug are
observed.
Establishes that the NCE (new chemical entity) is
effective in treating the disease in limited patient
populations (2A, about 100 subjects) and medium
populations (2B, about 300 subjects).
Phase III
During this phase, a variety of patients
with varying degrees of the disease
are studied
 Multicentre, controlled trials on
thousands of patients are run to
complete the establishment of safety,
efficacy and dosage for the
compound.
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Phase IV
Post-marketing surveillance is used to
monitor the drugs efficiency in treating
large populations
 Locate any reports of adverse effects
 Assess the relative efficacy of the
drug
 All reports on a drug that appear in
public are maintained by the company
marketing the drug
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The clinical study report
(CSR)
The CSR is the major set piece in a
clinical trial
 Built from all data on the drug
 Done in consultation with the
statisticians, the clinical team and the
medics
 This is the ultimate write-up of an
experiment ~ dissertation
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The CSR
Every pre-clinical and clinical study in
drug development has to be agreed
with the authorities before execution
and written up afterwards - as a CSR
 CSRs are the building blocks of a
Marketing Authorization Application
(MAA)
 http://www.emea.europa.eu/pdfs/hum
an/ich/013795en.pdf
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Who writes CSRs
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Medical writing groups within Pharma
companies, e.g.: Astra-Zeneca (Alderley
Edge), Genzyme (Cambridge)
Clinical research organisations: multiple
Specialist companies, e.g.:
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Constella Group (Milton Park):
www.constellagroup.com
Insight Medical Writing (Finstock):
www.insightmw.com
Publication planning
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Essentially how to disperse the information
from a clinical trial to as broad an audience
and in as many formats as possible
Conducted by med coms agencies for the
Pharma industry
Includes:
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posters
abstracts at meetings
peer review articles
symposia: slides, supplements, etc
Medical communication
agency writing
Peer review articles
 Slides
 Posters
 Abstracts
 Product monographs
 Internet writing
 Training manuals
 Newsletters, etc, etc
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Peer review papers
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If you can’t do this, the door is at the
back of the room……!
Slides
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Easy (?)
The scene of more communication atrocity
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Too many words
Too many fonts
Too many distractions
Bad line-data ratio
Refer to the master of good content:
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http://www.edwardtufte.com/tufte/
“The visual display of quantitative
information”
Conclusion
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You can specialize in an area – not unlike the status
achieved through a PhD or be a coverall
Your background in science provides you with the
equipment you need
Useful info:
 http://www.netsci.org/Courseware/Drugs/Intro/slide01.
html
 Albert: A-Z of medical writing. BMJ Books 2000
 American Psychological Association. Publication
manual (www.apa.org)
 Hall: How to write a paper. BMJ Books 2003