Drug Development in Oncology

Question 1

What is the estimated drug development success in oncology?

1 - 5%
2 - 15%
3 - 30%
4 - 50%

Answer 1

1 - 5%
- takes around 10 years from discovery to launching the drug
- costs over £1 billion

Question 2

There is around 5% success of drug development in oncology, but what % of these drugs are withdrawn from the market?

1 - 2.9%
2 - 10%
3 - 19%
4 - 33%

Answer 2

1 - 2.9%

Question 3

Which of the following is NOT part of the pre-clinical research into drug development?

1 - Identification and validation of disease-relevant target
2 - Identification and optimisation of inhibitor
3 - small human study (n=<50)
4 - In vitro (cell-based assays) and in vivo (animal) drug testing

Answer 3

3 - small human study (n=<50)

Question 4

Pharmacokinetics is what the body does to a drug. Which of the following is NOT part of pharmacokinetics?

1 - Absorption
2 - Digestion
3 - Distribution
4 - Metabolism
5 - Excretion

Answer 4

2 - Digestion

Question 5

Pharmacodynamics relates to what the drug will do to the body. How do researchers identify the first does that can be given to humans?

1 - base the dosage on weight in animal models and scale this up
2 - based on the dose that caused severe toxicity in 10% of animal models
3 - comparable with similar drugs
4 - all of the above can be applied

Answer 5

2 - based on the dose that caused severe toxicity in 10% of animal models

Question 6

In the clinical phase of a drug development, there are typically 3 stages. How many patients are required in stage 1 trial of the developed drug?

1 - 20-30
2 - 100-400
3 - 1000-4000
4 - based on power calculation from pre-clinical data

Answer 6

1 - 20-30
- single arm, non-RCT

• phase 2 = 100-400
• phase 3 = 1000-4000

Question 7

In the clinical phase of drug development, there are typically 3 stages. In stage 1 of a trial, typically includes 20-30 participants, what is the main question being asked?

1 - is it better than the standard
2 - is it safe
3 - is it active
4 - is it expensive

Answer 7

2 - is it safe
- stage 2 = is it active
- stage 3 = is it better than the standard

Question 8

In a phase 1 trial of a new drug being developed, the question being asked is whether the drug is safe. Then the maximum tolerated dose (MTD) can be given. What is the MTD?

1 - dose that has therapeutic effect, causing no adverse effects or toxicity
2 - dose that has some therapeutic effect and an acceptable toxicity
3 - dose that has therapeutic effect and an acceptable toxicity
4 - drug with no adverse effects or toxicity and has therapeutic effect

Answer 8

3 - dose that has therapeutic effect and an acceptable toxicity

Question 9

What is an open labelled trial?

1 - information is withheld from patients
2 - some patients are given information
3 - specific details are withheld from patients
4 - information is not withheld from patients

Answer 9

4 - information is not withheld from patients
- researchers are also aware of the allocation etc..

Question 10

What % of compounds advance from phase II to phase III studies?

1 - 3%
2 - 13%
3 - 30%
4 - 50%

Answer 10

3 - 30%

Question 11

Which of the following is not related to PK of a drug?

1 - The side effects
2 - The bioavailability
3 - The excretion
4 - The diffusion through the bowel into the blood stream

Answer 11

1 - The side effects

Question 12

What is the MTD=maximum tolerated dose?

1 - The maximum dose level to be used in animal model prior to clinical development
2 - The maximum dose level at which the drug has a therapeutic effect and acceptable toxicity in human studies
3 - The dose at which the study participants experience DLT (dose limiting toxicities) in a Phase I study
4 - The dose correspondent to severe toxicity in animal studies and based on which we determine the dose level to be used in first in human trials.

Answer 12

2 - The maximum dose level at which the drug has a therapeutic effect and acceptable toxicity in human studies