Slides from a University of Leicester CABS presentation about Working as a Clinical Trials Coordinator. (c) Sukhy Thandi, 2009

1. The Christie
NHS Foundation Trust
“WORKING IN CLINICAL TRIALS”
Sukhy Thandi
(BSc Biological Science, 2000; PhD Cell Physiology, 2004)

2. The Christie
NHS Foundation Trust
Present
The Christie Hospital in Manchester 2008 – present
The Christie is one of Europe's leading cancer centres,
treating over 40,000 patients a year.
Clinical Trials Coordinator

3. The Christie
NHS Foundation Trust
Clinical Trials
Several different types of Clinical Trials
- drug trials
- medical devices
- surgical / physical procedure
- therapy
Derek Crowther Clinical Trials Unit
- Clinical “drug trials” in cancer patients
Funding / collaborations from:
- drug companies (industry sponsors)
- Charities (e.g. CRUK)
- Department of Health

4. The Christie
NHS Foundation Trust
Clinical Trials of IMPs
“drug”: Investigational Medicinal Product – IMP
Clinical Trial of an IMP – CTIMPs!
Since 2004, all trials involving medicines for human use are
required by law to meet the EU clinical trials directive
- these regulations ensure all trials are carried out to the same standards
wherever they take place

5. The Christie
NHS Foundation Trust
Clinical Trials
Pre-clinical studies – extensive laboratory / animal testing
Phase I – first human trial for a new drug /treatment
(or first combination of two or more drugs / treatments)
- examine safety, toxicity and maximum tolerated dose
- usually few patients only (10-20)
Phase II – after safety profile ascertained from phase I, use larger
group of patients (20 -200)
Phase III – comparison with current treatments / placebo - may
involve hundreds/thousands of patients
Phase IV – Following licensing; ongoing assessment of long
term effects and benefits

6. The Christie
NHS Foundation Trust
Human Participants in Clinical Trials
Research participants make a significant contribution to the
progress of research and knowledge
Research involving human participants must meet both high
scientific and ethical standards
- benefits must outweigh risk of harm
Both independent Regulatory and Ethical approval is essential

7. The Christie
NHS Foundation Trust
Regulatory & Ethical Approval of CTIMPs
Medicines and Healthcare Products Regulatory Agency (MHRA)
- Ensure compliance with medicines for human use regulations 2004
National Research Ethics Service (NRES)
- Protect the dignity, rights, safety and well being of participants
- study design
- informed consent
- protect vulnerable persons
Trust approval from Research & Development (R&D)
- feasibility of studies
- adhere to GCP

8. The Christie
NHS Foundation Trust
Role of a Clinical Trial Coordinator
STUDY SET-UP
FEASIBILITY?
DATA
FINANCE
MANAGEMENT
Clinical Trial
Coordinator
MHRA
TRUST (sponsors for
APPROVAL
CTIMPs)
APPLYING TO
ETHICS

9. The Christie
NHS Foundation Trust
The Trail of Clinical Trials!
Aug 2008
Protocol
Oct 2008
MHRA
Specialised regulatory approval Dec 2008
- e.g. GTAC, ARSAC
Jan 2009
Ethical Approval
Feb 2009
Trust R&D approval
Feb 2009
Initiation of site
Mar 2009
Start recruiting patients!

10. The Christie
NHS Foundation Trust
Useful links
Medical Research Council (MRC)
- clinical trials toolkit: www.ct-toolkit.ac.uk
National Research Ethics Committee (NRES): www.nres.npsa.nhs.uk
Medicines and Healthcare products Regulatory Agency (MHRA):
www.mhra.gov.uk
For Trials Info’ in Cancer Research
- CRUK: www.cancerhelp.org.uk
- The Christie: www.christie.nhs.uk