This document provides a summary of Michelle Donnison's qualifications and experience as a Senior Pharmacy Technician, including her educational background and roles in clinical drug trials. It outlines the different phases of clinical drug trials, key roles and departments involved, therapeutic areas studied, and types of clinical trials conducted. Basic trial design elements like blinding and sponsorship are also defined. An example double-blind trial conducted at the author's hospital comparing crystalloids to HES fluid therapy is mentioned.

1. Michelle Donnison
Senior Pharmacy Technician

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BTEC National Diploma in Health Studies (2004)
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NVQ Level 3 in Pharmacy Services (2007)
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BSc (Hons) Medical Physiology (2011)
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Started working at York Hospital (2011)
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Postgraduate Certificate in Health Research (in
progress)

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Commercial (pharmaceutical companies)
Non-commercial / Academic (NHS,
charities, universities)
Observational studies
• Medical Device studies
• Drug Studies (CTIMP)
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Phase I – test the safety of a new drug in healthy
volunteers. Testing safety and establishing a safe dose
range (less than 100 people)
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Phase II – test the new drug on a larger group of people
who may benefit from the treatment (100 to 300 people)
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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)
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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)

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Sponsors
Doctors (Principal Investigators)
Research Nurses
Research & Development team
Other departments within Pharmacy
University of York (phase I studies)
Regulatory bodies (e.g. MHRA)

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Oncology
Haematology
Cardiology
Rheumatology
Stroke
Anaesthetics
Ophthalmology
Genitourinary Medicine
Dermatology
Renal
Neurological

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
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Open label – everyone knows what treatment
the patient is receiving
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Single blind – the patient does not know what
treatment they are receiving
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Double blind – everyone involved does not
know which treatment the patient has been
randomised to receive

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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.”

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Pharmacy Assistant
Clinical Trial Assistant
Clinical Research Associate
Research Nurse
Principal Investigator
Trial co-ordinator
Trial administrator
Data management