clinical trials

Question 1

phase 1 of clinical trials

Answer 1

• first in human
• dosing is guided by preclinical animal studies
• it is also multiplied by a safety factor
• healthy volunteers first
• with exception of oncology drugs (cancer)

research questions
- what doses can be tolerated
- what doses are safe
- how does the drug move in the body

• generally safe

Question 2

what is a biomarker

Answer 2

• a characteristic that is objectively measures and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention
• blood pressure
• temperature
• etc.
• decide whether or not the drug has had an effect
• ex: pregnancy test

Question 3

what is an adverse event

Answer 3

• any undesirable experience associated with the use of a medical product in a patient

Question 4

Serios AE

Answer 4

should be reported to FDA when patient outcome is:
- death
- life-threatening
- hospitalization
- disability/permanent damage
- birth defect
- required intervention

Question 5

pharmacokinetic testing in phase 1

Answer 5

• frequent blood and urine tests to measure drug concentration in bodily fluids
• gives an indication of where the drug is moving, how quickly it is being absorbed, how quickly it is being eliminated

Question 6

phase 2 clinical trials inclusion/exclusion criteria

Answer 6

inclusion
- ensure that relatively similar people take part in the trial

exclusion
- protects people that could be harmed by the drug study

Question 7

phase 2 trial stages

Answer 7

• screening
• randomization
• treatment period
• follow up visits
• end of study

Question 8

phase 2 trial designs

Answer 8

• many have a placebo