Objectives And Endpoints

Question 1

Objective versus end point.

Answer 1

Endpoints are the quantitative measurements required by the objective(s).

Question 2

Give 6 end point examples

Answer 2

1. Continuous measurements: blood pressure weight etc
2. Event x: time to recurrence of cancer, survival time etc
3. Counts: frequency of occurrence of migraine, number of uses of inhaler etc
4. Binary endpoints: major cardiac event yes or no, no recurrence or occurrence etc.
5. Ordered categories: absent mild moderate severe pain, ECOG status etc.
6. Unordered categories: adverse events.

Question 3

What is censoring with respect to event

Answer 3

an event time is censored if there is some amount of follow-up on the subject but the event is not observed because of loss to follow.

Question 4

What is a surrogate endpoint?

Answer 4

It is measured in place of the biologically definitive or clinically meaningful end point.

Question 5

What is the Fibonacci sequence?

Answer 5

A number in the sequence is the sum of the two previous numbers. 1,1,2,3,5,8,13 etc.

Question 6

How do precision and confidence interval relate?

Answer 6

The precision of an estimator will require a -for example- 95% confidence interval for the population mean to be within +/- δ units.

Question 7

Power definition

Answer 7

The probability that a trial will be able to detect a true response.