Clinical Trials

Question 1

Maximun tolerated dose is when dose limiting tocicity is seen in __ of __ people

Answer 1

2 of 6

Question 2

Phae 2 trials
- Use ___ and ___ trials

Answer 2

• Single
• Combination

Question 3

Phase 2 trials eligibility requirements
- Patients must have
- No ___ aka “standard regimen”

Answer 3

• Specific diagnosis
• Internal control group

Question 4

Phase 2 trials determin if the drug has ___

Answer 4

anti-tumor activity

Question 5

Phase 2 trials
- Complete responce is
- Partial responce is

Answer 5

• Disapperance of all measurable tumor
• Greater or equal than 50% regression of more evaluable lesions

Question 6

Phase 2 trials
- Stable disease is
- Progressive disease is

Answer 6

• Less than 50% reduction in tumor volume or lack of progression
• Occurance of any new lesion or current leasion increase by 25%

Question 7

Phase 3 trials
- Establish value of new

Answer 7

Treatment

Question 8

Phase 3 trials
- Benefits measures (3)

Answer 8

• Symptom control
• Disease free interval
• Survival

Question 9

Phase 3 trials
- Protocol must specify (3)

Answer 9

• Number of patients accured
• Duration of follow up after enrollment closes
• When final analysis will be performed

Question 10

What is a statistical test

Answer 10

Test that compares experimental treatment with control treatment

Question 11

Statistical significance is ___

Answer 11

0.05

Question 11

What is statistical significance

Answer 11

Measure of how likely the results are from a real effect and not chancce

Question 11

What is stratification

Answer 11

Selection of patients put into groups based on entry characteristics

Question 12

Stratification groups must be formed at the

Answer 12

Start of trial

Question 13

What is randomization

Answer 13

Patietns aare assigned to treatment type my random number

Question 14

Which trial type is considered the gold standard for research

Answer 14

Randomization

Question 15

non randomized studies
- Groups my differ by (2)
- Groups may recieve different

Answer 15

• disease and patient characteristics
• Diagnostic procedured
• Supportive care
• Secondary treatment
• Methods of evaluation
• Follow ups

Question 16

Phase IV studies
- Treatment becomes standard of care once

Answer 16

it is shown to be an improvement over previous treatments

Question 17

Phase IV studies
- Further investigation of … occure in this phase

Answer 17

• Feasibility and efficacy, in new and different setings

Question 18

Intention to treat principle
- States that
- Why?

Answer 18

• All randomized patients should be included in the primary analysis
• If patients experiencing sever side effects are exlluded, treatment will appear to be less toxic

Question 19

Interim analysis
- Random trends can ___
- A ___ will review interim results

Answer 19

• Destroy accural to clinical trial
• Data monitioring committe

Question 20

Health services research (5)

Answer 20

• Technology assessment
• Practice variations
• Medical decision making
• Cost effective
• Clinical practice guidelines

Question 21

F.A.C.T stands for

Answer 21

Functional
Assessment of
Cancer
Therapy
(scale for quality of life)

Question 22

Research data management is devoted to the ___ (4) of data

Answer 22

• collection
• storage
• retrieval
• quality control

Question 23

___ - ___ of eligible people enter clinical trains

Answer 23

1-3%

Question 24

Incluson of (2) is a priority in clinical trials

Answer 24

- Minorities - Women