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Drug development and the scribe

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

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Drug development and the scribe

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  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 (20–40) • 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. 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

  10. 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

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

  12. Peer review papers • If you can’t do this, the door is at the back of the room……!

  13. 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”

  14. 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/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

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