Clinical Trial Phases (Drug Studies)

Question 1

Which clinical trial phase does this describe:
- Delineate additional information about the drug’s risk, benefits and optimal use; continue assessing overall therapeutic value

Answer 1

Phase 4

Question 2

Which clinical trial phase does this describe:
- Combined population from several hundred to several thousand subjects

Answer 2

Phase 3

Question 3

Which clinical trial phase does this describe:
- Assess overall therapeutic value

Answer 3

Phase 3

Question 4

Which clinical trial phase does this describe:
- Obtain short-term safety data

Answer 4

Phase 2

Question 5

Which clinical trial phase does this describe:
- Address FDA requirements for additional information not in NDA

Answer 5

Phase 4

Question 6

Which clinical trial phase does this describe:
- Usually conducted at phase-specific units, tightly controlled, in-patient setting

Answer 6

Phase 1

Question 7

Which clinical trial phase does this describe:
- Establish long-term efficacy and safety, as appropriate

Answer 7

Phase 3

Question 8

Which clinical trial phase does this describe:
- Relatively small number of subjects per study

Answer 8

Phase 2

Question 9

Which clinical trial phase does this describe:
- Additional evidence of efficacy and safety

Answer 9

Phase 3

Question 10

Which clinical trial phase does this describe:
- Multi-center, well-controlled studies

Answer 10

Phase 2

Question 11

Which clinical trial phase does this describe:
- Small numbers of subjects per study and overall: generally in the range of 20 to 80.

Answer 11

Phase 1

Question 12

Which clinical trial phase does this describe:
- Confirmation of short-term efficacy and safety

Answer 12

Phase 3

Question 13

Which clinical trial phase does this describe:
- May be similar to Phase 2 or Phase 3 studies in design

Answer 13

Phase 4

Question 14

Which clinical trial phase does this describe:
- Design and number of subjects depends on study objective

Answer 14

Phase 4

Question 15

Which clinical trial phase does this describe:
- Usually single-center studies

Answer 15

Phase 1

Question 16

Which clinical trial phase does this describe:
- Normal volunteers or subjects with condition under study

Answer 16

Phase 1

Question 17

Which clinical trial phase does this describe:
- Initial demonstration of efficacy in subjects with the condition under investigation

Answer 17

Phase 2

Question 18

Which clinical trial phase does this describe:
- Establish overall benefit-risk relationship

Answer 18

Phase 3

Question 19

Which clinical trial phase does this describe:
- Surveillance for less common adverse events (spontaneous reports, registries)

Answer 19

Phase 4

Question 20

Which clinical trial phase does this describe:
- Supports final labeling content

Answer 20

Phase 3

Question 21

Which clinical trial phase does this describe:
- Expanded controlled and uncontrolled studies

Answer 21

Phase 3

Question 22

Which clinical trial phase does this describe:
- Combined population “usually involving no more than several hundred subjects”

Answer 22

Phase 2