Week 14

Question 1

How are SAD and MAD studies carried out?

Answer 1

1) 6 volunteers are initially invited
2) 1 or 2 of these subjects will act as sentinel subjects, where they will receive the first dose
3) If after 24 hours, the sentinel subjects do not have any adverse side effets, the rest of the cohort recieve the single dose
5) The safety review committee will review the adverse events and PK parameters
6) If there is no safety concern, the dose is escalated at the next cohort

Question 2

What is the difference between a victim and perpetrator drug?

Answer 2

Victim drug: the drug that is affected by the drug- drug interaction
Perpetrator drug: the drug that affects the PK of the other drug

Question 3

What is the 3+3 design in oncology studies?

Answer 3

1) 3 patients are treated at a low dose
2) If there is no dose limiting toxicities, the trial can proceed to the next higher dose with 3 new patients
3) If one DLT is observed among the 3 previous patients, 3 more patients are treated at this dose
4) If no DLTs are seen among these 3 new patients, the study moves on to the next dose
5) If 2 or more DLTs are found among the 6 patients, the maximum tolerated dose is defined as the previous dose
6) If 2 or 3 patients experience DLTs at any level, the previous dose becomes the MTD. This continues until an MTD is defined

Question 4

What is an adaptive trial design? (2)

Answer 4

If there are issues in the trial, the conduct of the trial can be changed
However, this must be pre- specified before the trial begins in the protocol