Clinical trials

Question 1

Phases of clinical trials

Answer 1

1. Pre-clincal phase
2. Phase I Human pharmacology
3. Phase II Therapeutic exploratory
4. Phase III Therapeutic confirmatory
5. Phase IV Therapeutic use

Question 2

Pre-clinical phase

Answer 2

Animal and laboratory studies

Question 3

Phase I Human pharmacology

Answer 3

Pharmacokinetics, pharmacodynamics, metabolism, dosage and safety

Question 4

Phase II Therapeutic exploratory

Answer 4

Safety and effectiveness

Question 5

Phase III Therapeutic confirmatory

Answer 5

Pre-marketing data to establish safety and efficacy against current gold standard treatment

Question 6

PPhase IV Therapeutic use

Answer 6

Post-marketing examination of long-term side effects, efficacy and evaluation of uses/doses in various populations/ethnicities

Question 7

Absolute risk reduction (ARR)

Answer 7

Absolute risk = number of people/total number of people
ARR = Absolute risk in group 1 - Absolute risk in group 2

Question 8

Relative risk reduction (RRR)

Answer 8

(Absolute risk in placebo group - Abolute risk in group X) / Absolute risk in placebo group

Question 9

Number needed to treat (NNT)

Answer 9

1/ARR

Question 10

Odds ratio (OR)

Answer 10

Odds in group 1 = Number of times it will happen/number of times it won’t happen
OR = Odds in group 1/Odds in group 2