Week 15

Question 1

What is the target product profile? (3)

Answer 1

A planning tool to focus the development and decision making of a drug candidate
It includes:
- Checkpoints
‘ Minimum’ represent the lowest level of efficacy that would be considered clinically meaningful

Question 2

What is interim analysis and what are the possible outcomes from it? (3)

Answer 2

Pre- planned checkpoints to review emergent trial data against target product profile
Possible outcomes:
- Futility- stop ineffective treatment early
- Accelerate- invest in acceleration of effective treatment