1. What is the primary purpose of conducting clinical trials?

a) To collect data on the safety and efficacy of new drugs and medical devices
b) To monitor the effects of medications on large groups of people
c) Both a and b
d) None of the above

2. How many phases are there in clinical trials?

a) 2
b) 3
c) 4
d) 5

3. What is the focus of Phase I clinical trials?

a) Safety and tolerability of new drugs or devices on humans
b) Pharmacokinetics and effects of the drug on humans at specific doses
c) Both a and b
d) None of the above

4. How many volunteers usually participate in Phase I clinical trials?

a) 10-20
b) 20-100
c) 100-200
d) 200-500

5. Where are Phase I clinical trials typically conducted?

a) Health care settings
b) Tightly controlled clinics with 24-hour medical attention
c) Pharmaceutical companies' research labs
d) Both a and b

6. In which cases are phase 1 trials performed in patients with the disease?
a) When the drug is too toxic for healthy subjects
b) When the drug is being tested for cancer treatment
c) Both a and b
d) None of the above

7. What percentage of experimental drugs pass Phase I testing?

a) 50%
b) 60%
c) 70%
d) 80%

8. What is the primary focus of Phase II trials?

a) Safety, efficacy, and dosage range in patients with relevant diseases
b) Pharmacokinetics and efficacy of the drug at specific doses
c) Comparing the drug with other drugs already in the market
d) None of the above

9. How many stages are there in Phase II trials?

a) 1
b) 2
c) 3
d) 4

10. What is the purpose of the early stage in Phase II trials?

a) To determine the dosage, efficacy, and safety of the drug over a short period
b) To review data and obtain regulatory approval for the late stage
c) Both a and b
d) None of the above
11. How long does the late stage of Phase II trials typically last?
a) 6 months to 1 year
b) More than 2 years
c) 1-2 weeks
d) 1-2 months

12. How are Phase II trials randomized and blinded?

a) Placebo-controlled with inactive starch molecule or older active drug
b) Open-label with no blinding
c) Both a and b
d) None of the above

13. What percentage of experimental drugs successfully complete both Phase I and
Phase II studies?
a) 20%
b) 33%
c) 50%
d) 75%

14. What is the primary focus of Phase III trials?

a) Understanding the drug's properties, efficacy, adverse/side effects, and
benefits in large populations
b) Comparing the drug with other drugs already in the market
c) Monitoring the drug's long-term effectiveness and impact on patients' quality of
life
d) None of the above

15. How many patients are typically involved in Phase III trials?
a) 10-150
b) Several hundred to several thousand
c) 1000-5000
d) 5000-10,000

16. How long can Phase III trials last?

a) Several months to 1 year
b) 1-2 weeks
c) 2-5 years
d) 5-10 years

17. What percentage of drugs that enter Phase III studies successfully complete
this phase of testing?
a) 30%
b) 50%
c) 70%
d) 90%

18. What is the purpose of Phase IV trials?

a) Comparing the drug with other drugs already in the market for cost-effectiveness
and risk-benefits
b) Monitoring the drug's long-term effectiveness and impact on patients' quality of
life
c) Both a and b
d) None of the above

19. Who sponsors Phase IV trials?

a) Pharmaceutical companies
b) Government agencies
c) Independent research organizations
d) Patients' advocacy groups

20. What can happen to a drug or device based on the findings in Phase IV trials?
a) It can be withdrawn from the market
b) It can be restricted from use under certain conditions
c) Both a and b
d) None of the above