L9 Phase I to III trials

Question 1

What is the purpose for each phase + sample size + duration?

Answer 1

Slide 4

Question 2

What are the pre-clinical requirements?

Answer 2

Slide 5 + Lecture 3

Question 3

What is the purpose of Phase I trials?

Answer 3

Slide 10

Question 4

Who is chosen for Phase I trials?

Answer 4

Slide 11

Question 5

What are the characteristics of patients usually selected for Phase I trial?

Answer 5

Slide 12

Question 6

Who conducts phase I trials?

Answer 6

Slide 13

Question 7

What are the endpoints for Phase I trials?

Answer 7

Slide 14

Question 8

What equipment is needed for Phase I trials?

Answer 8

Slide 15
- Must be inpatient

Question 9

What is adverse drug reactions (give some egs)

Answer 9

Slide 16

Question 10

How do you select dosage for Phase I study?

Answer 10

Slide 24

Question 11

What are the different study designs for Phase I trial?

Answer 11

Slide 25 + adv/disadv

Question 12

What is the purpose of Phase II trials? What is the sample size?

Answer 12

Slide 32

Question 13

Who conducts phase II trials?

Answer 13

Slide 33

Question 14

What is the purpose of Phase IIa trials + what are the endpoints?

Answer 14

Slide 34
- Usually open trials (open label trials)

Question 15

What is the purpose of Phase IIb trials + what are the endpoints?

Answer 15

Slide 35 + 36

Question 16

What are some biases that could occur within the trial

Answer 16

• Slide 39 (wax and wane diseases, how you feel instead of an objective BM to measure surrogate endpoints)
• Slide 40: Subjects improving their lifestyle because they are taking a medication to improve their diseases etc, may have other diseases or taking concurrent medications
• Investigators treating patients with the tested drug differently from placebo?

Question 17

What can biases arise and how do we reduce biases?
How long can we put people on placebo (no drug)?

Answer 17

Slide 42
Slide 43-57
Slide 50: depending on the disease condition (life threatening or not etc)

Question 18

What is control group?

Answer 18

Slide 58

Question 19

What is a wash-out period?

Answer 19

Slide 59

Question 20

What are the different outcome measures and how should it be treated?

Answer 20

Slide 62-68

Question 21

What is the difference between subjective and objective endpoint?

Answer 21

Slide 69, 70

Question 22

What is the purpose of Phase III trials and how is it conducted?

Answer 22

Slide 73, 74

Question 23

Which group of people should be excluded from studies?

Answer 23

Slide 81

Question 24

What is the purpose of post market surveillance?

Answer 24

Slide 94, 96

Question 25

What happens when rare ADR is reported in phase IV?

Answer 25

Slide 100

Question 26

When does drug get withdrawn?

Answer 26

Slide 101, 102

Question 27

What are some examples of drugs that were withdrawn?

Answer 27

Rofecoxib - COX inhibitor for gastric; withdrawn due to MI/Cardiac toxicity Thioridazine - antipsychotic; associated with sudden CV collapse and death Nefazodone - causes liver failure