Drug Development + Clinical Trials

Question 1

What are the four phases of drug development?

Answer 1

• phase 1: small studies on healthy volunteers | used to assess pharmacodynamics + pharmacokinetics
• phase 2: small studies on actual patients | examines efficacy + adverse effects
• phase 3: larger studies on patients | examines efficacy, adverse effects, comparision of drug to existing treatment
• phase 4: post marketing surveillance

Question 2

What is phase 1 of drug development?
What is it used for?

Answer 2

Small study on healthy volunteers
Used to assess pharmacodynamics + pharmacokinetics

Question 3

What is phase 2 of drug development?
What is it used for?

Answer 3

• small study on actual patients
• assess efficacy + adverse effects

Question 4

What is phase 3 of drug development?
What is it used for?

Answer 4

• larger study on actual patients
• assesses efficacy + adverse effects
• comparison with other drug treatments

Question 5

What is phase 4 of drug development?

Answer 5

Post marketing surveillance

Question 6

What can be used to report adverse drug reactions?

Answer 6

Yellow card scheme

Question 7

What is the yellow card scheme used for?

Answer 7

• all suspected ADR in new products (including minor)
• serious/unusual reactions to established products

Question 8

What are the goals of clinical trials phases?

Answer 8

• phase 0: exploratory studies
• phase I: safety assessment
• phase II: assess efficacy
• phase III: assess effectiveness
• phase IV: post markerting surveillance

Question 9

Efficacy definition

Answer 9

The ability of a drug after binding to a receptor to initiate change which leads to certain events

Question 10

Outline phase 0 clinical trails

Answer 10

• exploratory studies
• small number of volunteers
• to assess how drug behaves in human body
• determines whether it is feasible to move on to further phases

Question 11

Outline phase I clinical trials

Answer 11

• safety assessment
• conducted on healthy volunteers
• determines side effects prior to larger studies

Question 12

Outline phase II clinical trials

Answer 12

• small number of patients
• IIa: assess optimal dosing
• IIb: assess efficacy

Question 13

Outline phase III clinical trials

Answer 13

• often as part of RCT
• comparing new treatment with established treatment
• assess effectiveness

Question 14

Outline phase IV clinical trials

Answer 14

• post marketing surveillance
• monitoring long term effectiveness + side effects