Drug Discovery

Question 1

Prior to any clinical trials a drug or new compound needs to be identified, followed by pre-clinical research. The we can enter clinical trials. What is a phase 0 trial in clinical research?

1 - comparing the new drug to current treatment for specific condition, 1000-5000 people
2 - optimising the dose, while learning about side effects and the effect of the drug as a treatment in around 100-400 people
3 - testing low dose of drug for safety in small group of people 10-50
4 - testing long term benefits and side effects in thousands to millions
5 - optimising dose of a drug while understanding effects of treatment in around 50-200 people

Answer 1

3 - testing low dose of drug for safety in small group of people 10-50

Question 2

Prior to any clinical trials a drug or new compound needs to be identified, followed by pre-clinical research. The we can enter clinical trials. What is a phase 1 trial in clinical research?

1 - comparing the new drug to current treatment for specific condition, 1000-5000 people
2 - optimising the dose, while learning about side effects and the effect of the drug as a treatment in around 100-400 people
3 - testing low dose of drug for safety in small group of people 10-50
4 - testing long term benefits and side effects in thousands to millions
5 - optimising dose of a drug while understanding effects of treatment in around 50-200 people

Answer 2

5 - optimising dose of a drug while understanding effects of treatment in around 50-200 people

Question 3

Prior to any clinical trials a drug or new compound needs to be identified, followed by pre-clinical research. The we can enter clinical trials. What is a phase 2 trial in clinical research?

1 - comparing the new drug to current treatment for specific condition, 1000-5000 people
2 - optimising the dose, while learning about side effects and the effect of the drug as a treatment in around 100-400 people
3 - testing low dose of drug for safety in small group of people 10-50
4 - testing long term benefits and side effects in thousands to millions
5 - optimising dose of a drug while understanding effects of treatment in around 50-200 people

Answer 3

2 - optimising the dose, while learning about side effects and the effect of the drug as a treatment in around 100-400 people

Question 4

Prior to any clinical trials a drug or new compound needs to be identified, followed by pre-clinical research. The we can enter clinical trials. What is a phase 3 trial in clinical research?

1 - comparing the new drug to current treatment for specific condition, 1000-5000 people
2 - optimising the dose, while learning about side effects and the effect of the drug as a treatment in around 100-400 people
3 - testing low dose of drug for safety in small group of people 10-50
4 - testing long term benefits and side effects in thousands to millions
5 - optimising dose of a drug while understanding effects of treatment in around 50-200 people

Answer 4

1 - comparing the new drug to current treatment for specific condition, 1000-5000 people

Question 5

Prior to any clinical trials a drug or new compound needs to be identified, followed by pre-clinical research. The we can enter clinical trials. What is a phase 4 trial in clinical research?

1 - comparing the new drug to current treatment for specific condition, 1000-5000 people
2 - optimising the dose, while learning about side effects and the effect of the drug as a treatment in around 100-400 people
3 - testing low dose of drug for safety in small group of people 10-50
4 - testing long term benefits and side effects in thousands to millions
5 - optimising dose of a drug while understanding effects of treatment in around 50-200 people

Answer 5

4 - testing long term benefits and side effects in large and medium size studies

Question 6

Match the definition to type I and type II errors:

• null hypothesis is accepted when it is false (failing to spot a difference when there is one)
• null hypothesis is rejected when it is true (showing a difference, when there is not one, a false positive)

Answer 6

type II - null hypothesis is accepted when it is false (failing to spot a difference when there is one)

type I - null hypothesis is rejected when it is true (showing a difference, when there is not one, a false positive)