Phases of trials

Question 1

Pre-clinical studies

• Why?
• what happens?

Answer 1

Identify a promising compound
Animal testing
Safety evaluation
Preliminary pharmacokinetics

Question 2

Phase I clinical trials

• Why?
• what happens?

Answer 2

Focus on PHARMACOLOGY- dose finding, mode delivery, dose schedule
Also safety

usually healthy subjects 15-30 but can use volunteers with severe illness

Question 3

Phase II clinical trials

• Why?
• what happens?

Answer 3

Focus on SAFETY

Also pharmacology and efficacy
Usually subjects with target disease

Question 4

Phase III clinical trials

• Why?
• what happens?

Answer 4

Focus on EFFICACY

Also safety and pharmacology
100-1000s of patients with target disease, often multi centre

Question 5

Phase IV studies

• Why?
• what happens?

Answer 5

Long-term SAFETY
Post marketing surveillance
Longer term follow up of drug users