Clinical trials

Question 1

Give the 4 phases of clinical development

Answer 1

Phase 1 - volunteer studies - around 100
phase 2 - clinical investigation to confirm kinetics and dynamics in patient - provides evidence of efficacy and identify dosage range
Phase 3 - formal therapeutic trials and evidence of safety obtained. All data submitted to regulatory authority
Phase 4 - post marketing surveillance to produce evidence of long term safety

Question 2

Define randomised control clinical trials

Answer 2

Pateints assigned at random to either treatment or control (placebo - inactive drug)

Question 3

Describe superiority and non-inferiority trials

Answer 3

Superiority - Show that new treatment is better than the control or standard
Non-inferiority - Show that new treatment is worse than the standard by some margin

Question 4

Give factors to consider when designing a study

Answer 4

• number of subjects
• choice of control drug
• choice of patients (age/ sex/ race)
• exclusion and selection criteria (pregnant/ kids/ immunocomprimised/ renal function)