Midterm-ExpectedQuestions

Question 1

Define a clinical trial.

Answer 1

A prospective study comparing the effects and value of intervention(s) against a control in human beings.

Question 2

Explain the relationship between variance, sample size and power.

Answer 2

As variance increases:

• if sample size is held constant then power decreases
• if power is held constant then sample size must increase

Question 3

Briefly describe the four phases of clinical trials and their primary goals.

Answer 3

Phase 1 - Pharmacokinetics (maximum tolerable dose)

Phase 2 -
Efficacy (does it work in controlled setting)

Phase 3 -
Evaluation of Treatment

Phase 4 -
Follow up of mortality and morbidity long term wide scale