What do clinical trials provide evidence of?
Drugs are safe and effective
How many prescriptions do GPs give out per day on average?
How much does the NHS spend on drugs each year?
What are examples of drugs that were developed before clinical trials were required, what does this explain?
Warfarin and digoxin which is why they have so many side effects
What is an observational study?
Observes individuals without manipulation or intervention
What are some problems with observational studies?
Replication is difficult due to bias/different criteria
What do clinical trials prove (in terms of putting theory into practice)?
What works in theory might not work in practice
Why does the process of getting a drug onto the market take years?
Need to go through all of the stages to be approved for a license
Who are clinical trials regulated by?
What is tested during clinical trials?
How is the efficacy of a drug compared?
With placebo or another drug
What are some laws which cover drug trials?
UK Medicines Act 1968
The Medicines for Human Use (Clinical Trials) Regulations 2004 and 2014
What are the stages of drug development?
1) Drug discovery
2) Pre-clinical development
3) Clinical development
What is tested during pre-clinical development?
What are the stages of clinical development?
1) Phase 1 (volunteer studies)
2) Phase 2 (given to patients)
3) Phase 3 (formal therapeutic trials)
4) Phase 4 (post marketing surveillance)
What is tested during phase 1 trials?
Clinical pharmacology in normal volunteers
How many subjects are used in phase 1?
What happens during phase 2?
Clinical investigations in patients to confirm kinetics and dynamics
Evidence of efficacy and likely dosage range
How many subjects are used during phase 2?
Up to 500
What happens during phase 3?
Formal therapeutic trials establish efficacy and evidence of safety
All data submitted as an application for a license to sell the drug
How many subjects are used during phase 3?
1000 - 3000
What happens during phase 4?
Post marketing surveillance to produce evidence of long term safety
How many people can phase 4 involve?
Tens to hundreds of thousands
When do tegenero trials happen?
During phase 1
What are tegerno trials?
Involves 8 patients:
6 given drug intravenously
2 given placebo
What do pilot studies test and what do they not test?
They do not test outcome but test the study design
What are examples of different pilot studies?
What is a double blind study?
Patient and doctor are blinded
What is a single blind study?
Patient is blinded
What is a prospective study?
Protocol is decided beforehand