Drug Information II Study Guide

1) An evaluation used to rank performance was assessed using a 5- point Likert

scale (1 = I stunk, 5=I was amazing). Which type of data best describes the
scale used?

2) Name 2 types of interval data.

3) Name a type of ratio data.

4) What type of figure is this? How many total people were randomized into the
treatment groups?
5) Please define each of the following clincial trial designs:
a. Randomized Controlled Trials:

b. Noninferiority Trials: (Null hypothesis?)

c. Cohort Study:

d. Case-Control Study:

e. Meta-analysis:

For questions 6-8.

A randomized, controlled clinical trial was conducted to assess rosuvastatin
as primary prevention to decrease the risk of cardiovascular events over 5
years. The primary composite endpoint was the occurrence of first major
cardiovascular event, defined as a nonfatal myocardial infarction (MI),
nonfatal stroke, hospitalization for unstable angina, or confirmed death from
CV causes. Results for this study:

Rosuvastatin Placebo 95% Confidence

Interval (Relative
Risk)
Primary 1.6% 2.8% 1.56 (0.46-0.69)
endpoint

6) What is the absolute risk reduction?

7) What is relative risk reduction?

8) What is the number needed to treat?

 9) Are these results statistically significant? Are they clinically significant? Justify
your answer.

For questions 10 -11.

The information below has been adapted from the package insert for Toprol
XL.

Clinical Endpoints in the MERIT-HF Study

Risk
Number of Relative Nominal
Clinical Endpoint Number of Reduction
Patients Risk P-value
Patients With
(95% C1)
TOPROL-XL
Placebo TOPROL-XL
n=2001 n=1990
All-cause mortality plus 0.81(0.73-
767 641 19% 0.00012
all-caused hospitalization 0.90)
0.66(0.53-
All-cause mortality 217 145 34% 0.00009
0.81)

10) What is the absolute percent reduction in all-cause mortality for Toprol
XL?

11) What is the number need to treat?

12) The primary endpoint of a study was the sum of pain intensity
difference over 5 days. Which type of blinding would be most appropriate to
minimize bias?

For Questions 12-13.

The PALLAS studys rationale was to test whether dronedarone (Multaq)
would reduce rates of major vascular events or unplanned hospitalization for
cardiovascular causes in patients with permanent atrial fibrillation who were
at high risk for vascular events.

13) What is the null hypothesis of this study?

14) What is the study hypothesis of this study?

15) Interpret what Type I and Type II errors are. (Randomized controlled
trials)

16) Investigators decided to analyze the results of their study with only the
patients who completed an 8 week study. What type of analysis is this and
how does it compare to an intention to treat analysis?

17) What is null data?

18) What bias does null data minimize? Why?

19) Where can you find unpublished clinical trials?

20) When would you utilize information presented at a FDA Advisory

Committee?

21) Define the placebo effect.

22) What are the factors that influence the placebo effect? (General
factors, for example attitude of the patient)
23) What is a nocebo effect?

24) Differentiate between intention to treat, per protocol, and as treated

analyzes.
ITT:

PP:

AT:

25) What is a NI margin? Based on a graph, how would you determine a

new treatment is better, non-inferior, or worse?

a. If the CI lies wholly to the left of zero

b. If the CI lies to the left of the noninferior margin and includes 0
c. If the CI lies fully to the right of the margin

26) What are biases associated with:

a. Non-inferiority trials:

b. Cohort Studies:

c. Case-control studies:

d. Meta-analyzes:

27) What are the statistical tests used in a cohort study and a case-control
study? How would you calculate a relative risk and odds ratio?
a. Cohort:

b. Case- Control:
 For Questions 28-30.

28) What type of figure is this?

29) Based on this figure what would your interpretation of this meta-
analysis be? Was this a statistically significant trial? Why or why not?

30) What is the overall heterogeneity of this meta-analysis?

31) If investigators of a randomized, controlled trial were not adequately blinded

to which patient received drug A versus B, which type of validity would this
affect?