Clinical Trial Design

Question 1

Regulated by the MHRA

Answer 1

Medicines for human use (2004)

Question 2

Phase 1

Answer 2

Volunteer studies

normal humans - pharmacokinetic and dynamic data gained

100 subjects

Question 3

Phase 2

Answer 3

Drugs to patients

gives efficacy and dosage range

500 patients

Question 4

Phase 3

Answer 4

Clinical development

formal therapeutic trails where efficacy will be established and evidence of safety obtained

1000-3000 patients

Data submitted as an application to the regulatory authority for license to sell the drug

Question 5

Phase 4

Answer 5

Post-marketing surveillance to produce evidence of long term safety