Abstract 1 EXAM 3

Question 1

What type of study?

Answer 1

RCT

Question 2

What is the primary endpoint?

Answer 2

Time to clinical improvement up to 28 days

Question 3

What is a Per Protocol analysis?

Answer 3

-It is the most pure and rigorous analysis to test the drug

-Patients behave strictly according to the protocol
-Patients who deviate from the protocol are eliminated from the study

Question 4

Which type of analysis has the highest internal validity?

Answer 4

Per Protocol Analysis

Question 5

What is the reason for using the per-protocol analysis?

Answer 5

To exclude patients who have side effects and can’t tolerate the drug

BUT: Potential side effects we want to know of, are missed

Question 6

What is the Intention to Treat Analysis?
IIT

Answer 6

All patients enrolled in the study were intended to be treated, therefore they are going to be analyzed

The drug is tested under the worst conditions, including patients who are not adherent

Question 7

What is a modified Intention to Treat Analysis?
mIIT

Answer 7

The IIT conditions are modified

f.e. exclude the data of patients who drop out after 2 days

Question 8

Which of the results were statistically significant?

Answer 8

….

Question 9

Why is the HR greater than 1 considered beneficial in this study?

Answer 9

Because the study looks at the time before the patient’s condition declines
the longer, the greater the value of the nominator

Question 10

Remdesivir was stopped early because of
adverse events in 18 (12%) patients versus four (5%) patients who stopped placebo early

What type of data?

Answer 10

Either the patient has an ADR or not; so ORDINAL