Clinical Trials

Question 1

Phase 1

Answer 1

Volunteer studies using normal volunteers to study pharmokinetics, pharmodynamics and metabolism

Question 2

Phase 2

Answer 2

Drug given to small number of patients to confirm kinetics and dynamics
Provides evidence of efficacy and likely dosage range

Question 3

Phase 3

Answer 3

Formal therapeutic trials to establish efficacy and safety

Question 4

Phase 4

Answer 4

Drug is put on market and surveyed for long term safety

Question 5

Pre-clinical trial

Answer 5

Animal pharmacology (dose, adverse effects)
Animal toxicology (teratogenecity, fertility, mutagenicity)

Question 6

Double blind

Answer 6

Patient and doctor both blind

Question 7

Single blind

Answer 7

Patient blinded

Question 8

Prospective

Answer 8

Design protocol beforehand and what results they expect

Question 9

Retrospective

Answer 9

At the end of study look back to see any evidence supporting drug- open to bias

Question 10

Placebo controlled studies

Answer 10

Compare 2 groups one with drug and one with placebo

Question 11

Comparison with other therapy

Answer 11

Compare 2 groups one with study drug and one with the comparison therapy

Question 12

Cross over design

Answer 12

Compare outcomes with study drug and compared therapy on same patient

Question 13

Randomised Control Clinical Trial

Answer 13

Randomly assign volunteers to either treatment or control

Question 14

Gold standard

Answer 14

Randomised Control Clinical Trial

Question 15

Disadvantages of randomised control clinical trial

Answer 15

Not side enough population to make generalisations
Twice as many new patients needed for study
Some physicians will refuse
Some patients will refuse an want treatment
Administration is complex