Drug development and the scribe - PowerPoint PPT Presentation

About This Presentation
Title:

Drug development and the scribe

Description:

Specialisation: Urology/Oncology/Dermatology. Medical writing course: EAU. Phase I ... Patient population is a limited group of healthy volunteers (20 40) ... – PowerPoint PPT presentation

Number of Views:38
Avg rating:3.0/5.0
Slides: 18
Provided by: christine67
Category:

less

Transcript and Presenter's Notes

Title: Drug development and the scribe


1
Drug development and the scribe
  • Dr Christine McKillop
  • Medscimedia Ltd

2
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

3
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

4
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).

5
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.

6
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

7
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

8
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

9
(No Transcript)
10
(No Transcript)
11
(No Transcript)
12
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

13
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

14
Medical communication agency writing
  • Peer review articles
  • Slides
  • Posters
  • Abstracts
  • Product monographs
  • Internet writing
  • Training manuals
  • Newsletters, etc, etc

15
Peer review papers
  • If you cant do this, the door is at the back of
    the room!

16
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

17
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
Write a Comment
User Comments (0)
About PowerShow.com