Drug development and the scribe

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Drug development and the scribe

• Dr Christine McKillop
• Medscimedia Ltd

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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

• Establishes safety in humans
• Patient population is a limited group of healthy
  volunteers (2040)
• The studies are used to determine
• toxicity
• dosages (formulations and amounts)
• blood levels
• excretion profiles
• pharmacokinetic profiles

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Phase II

• 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).

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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/human/ich/013795en.
  pdf

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Who writes CSRs

• Medical writing groups within Pharma companies,
  e.g. Astra-Zeneca (Alderley Edge), Genzyme
  (Cambridge)
• Clinical research organisations multiple
• Specialist companies, e.g.
• Constella Group (Milton Park) www.constellagroup.
  com
• Insight Medical Writing (Finstock)
  www.insightmw.com

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Publication planning

• 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
• posters
• abstracts at meetings
• peer review articles
• symposia slides, supplements, etc

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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

• If you cant do this, the door is at the back of
  the room!

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Slides

• Easy (?)
• The scene of more communication atrocity
• Too many words
• Too many fonts
• Too many distractions
• Bad line-data ratio
• Refer to the master of good content
• http//www.edwardtufte.com/tufte/
• The visual display of quantitative information

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Conclusion

• 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/slide
  01.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