Brainscape's Knowledge GenomeTM

Browse over 1 million classes created by top students, professors, publishers, and experts.


See full index

LSM4221 (Other lectures) > L9 Phase I to III trials > Flashcards

L9 Phase I to III trials Flashcards

1
Q

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

A

Slide 4

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

What are the pre-clinical requirements?

A

Slide 5 + Lecture 3

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

What is the purpose of Phase I trials?

A

Slide 10

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

Who is chosen for Phase I trials?

A

Slide 11

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

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

A

Slide 12

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

Who conducts phase I trials?

A

Slide 13

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

What are the endpoints for Phase I trials?

A

Slide 14

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

What equipment is needed for Phase I trials?

A

Slide 15
- Must be inpatient

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

What is adverse drug reactions (give some egs)

A

Slide 16

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

How do you select dosage for Phase I study?

A

Slide 24

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

What are the different study designs for Phase I trial?

A

Slide 25 + adv/disadv

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

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

A

Slide 32

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

Who conducts phase II trials?

A

Slide 33

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

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

A

Slide 34
- Usually open trials (open label trials)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

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

A

Slide 35 + 36

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

What are some biases that could occur within the trial

A
  • 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?
17
Q

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

A

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

18
Q

What is control group?

A

Slide 58

19
Q

What is a wash-out period?

A

Slide 59

20
Q

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

A

Slide 62-68

21
Q

What is the difference between subjective and objective endpoint?

A

Slide 69, 70

22
Q

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

A

Slide 73, 74

23
Q

Which group of people should be excluded from studies?

A

Slide 81

24
Q

What is the purpose of post market surveillance?

A

Slide 94, 96

25
Q

What happens when rare ADR is reported in phase IV?

A

Slide 100

26
Q

When does drug get withdrawn?

A

Slide 101, 102

27
Q

What are some examples of drugs that were withdrawn?

A

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

LSM4221 (Other lectures) (12 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2024 Bold Learning Solutions. Terms and Conditions