Lecture 7 - Clinical Pharmacology Part 2

Question 1

what is a clinical trial?

Answer 1

a prostpective experiment with human subjects which tests a defined intervention, is compared with a control group, and has defined outcomes

Question 2

list the four main features of a clinical trial

Answer 2

1) informed consent (must tell subject about risks and benefits)
2) randomization of treatment group
3) blinding
4) placebo

Question 3

what is blinding in a clinical trial?

Answer 3

you don’t know whether you’re getting treatment or placebo

Question 4

what is the purpose of randomizing the treatment group?

Answer 4

removes bias and distributes extraneous variables between the groups

Question 5

why do we need clinical trials?

Answer 5

they are the best method to determine if a therapy works

Question 6

is a clinician’s experience in the field sufficient to know whether or not a therapy works?

Answer 6

nope

Question 7

diseases are generally not well understood enough to know if:

Answer 7

a therapy will work (based on pharmacology alone)

Question 8

type of clinical trial which tests for the maximally tolerated dose of a drug in a small number of patients

Answer 8

phase I

Question 9

type of clinical trial which tests for biologic activity and adverse effects in 14-30 subjects

Answer 9

phase II

Question 10

at what stage in clinical trials are patients with a disease being tested?

Answer 10

phase II

Question 11

what is the purpose of a phase II clinical trial?

Answer 11

tests for safety

Question 12

type of clinical trial which tests for effectiveness of the drug/treatment as well as adverse effects

Answer 12

phase III

Question 13

a control group is required for a ______ clinical trial

Answer 13

phase III

Question 14

a phase III clinical trial is necessary to receive a:

Answer 14

notice of compliance (NOC) - aka drug approval

Question 15

type of clinical trial which analyses the long term effectiveness of a drug and detects rare adverse events

Answer 15

phase IV

Question 16

what type of studies are phase IV clinical trials?

Answer 16

observational studies without control groups; it is an evaluation across several populations

Question 17

phase IV clinical trials are also known as:

Answer 17

postmarketing surveillance

Question 18

health services research can be _____ or _____ studies

Answer 18

phase III, phase IV

Question 19

why do we need health services research?

Answer 19

just because a therapy is proven, doesn’t mean that it is used (or used properly) in those who could benefit

Question 20

clinical trials are the _____ of drug development

Answer 20

final stages

Question 21

clinical trials generate evidence to guide:

Answer 21

treatment and healthcare policy, as well as treatment approaches/delivery