Pharmacy in clinical trials

49,765 views

Published on

0 Comments
2 Likes
Statistics
Notes
  • Be the first to comment

No Downloads
Views
Total views
49,765
On SlideShare
0
From Embeds
0
Number of Embeds
43,813
Actions
Shares
0
Downloads
0
Comments
0
Likes
2
Embeds 0
No embeds

No notes for slide

Pharmacy in clinical trials

  1. 1. Michelle Donnison Senior Pharmacy Technician
  2. 2. • BTEC National Diploma in Health Studies (2004) • NVQ Level 3 in Pharmacy Services (2007) • BSc (Hons) Medical Physiology (2011) • Started working at York Hospital (2011) • Postgraduate Certificate in Health Research (in progress)
  3. 3. • • Commercial (pharmaceutical companies) Non-commercial / Academic (NHS, charities, universities) Observational studies • Medical Device studies • Drug Studies (CTIMP) •
  4. 4. • Phase I – test the safety of a new drug in healthy volunteers. Testing safety and establishing a safe dose range (less than 100 people) • Phase II – test the new drug on a larger group of people who may benefit from the treatment (100 to 300 people) • Phase III – test the new drug in larger groups of ill people. Compare a new drug against an existing treatment or a placebo (1000 to 3000 people) • Phase IV – occur once new medicines have been given a marketing licence. Investigate safety, side effects and effectiveness of the drug (more than 3000 people)
  5. 5. • • • • • • • Sponsors Doctors (Principal Investigators) Research Nurses Research & Development team Other departments within Pharmacy University of York (phase I studies) Regulatory bodies (e.g. MHRA)
  6. 6. • • • • • • • • • • • Oncology Haematology Cardiology Rheumatology Stroke Anaesthetics Ophthalmology Genitourinary Medicine Dermatology Renal Neurological
  7. 7. Setting up clinical trials • Ordering Investigational Medicinal Products (IMPs) • Receiving IMP • Dispensing • Drug accountability • Returning/destroying IMP • Temperature monitoring • Hosting monitoring visits • Trial initiation meetings • Writing standard operating procedures •
  8. 8. • Open label – everyone knows what treatment the patient is receiving • Single blind – the patient does not know what treatment they are receiving • Double blind – everyone involved does not know which treatment the patient has been randomised to receive
  9. 9. • • • • Trust-sponsored study Pharmacy only unblinded team Published in British Journal of Anaesthesia in 2013 Concluded “Goal-directed fluid therapy is possible with either crystalloid or HES. There is no evidence of a benefit in using HES over crystalloid, despite its use resulting in a lower 24 hour fluid balance.”
  10. 10. • • • • • • • • Pharmacy Assistant Clinical Trial Assistant Clinical Research Associate Research Nurse Principal Investigator Trial co-ordinator Trial administrator Data management

×