M.sc. (Statistics) (Semester IV) (CBCS) Examination,2017
Clinical Trials
Day Date: Friday, 28-04-2017 Max. Marks: 70
Time: 02.30 PM to 05.00 PM
N.B. Q.No.(1) and Q.No.(2) are compulsory
Attempt any three from Q.No.(3) to Q.No.(7)
Figures to the right indicate full marks.
Q.1 Select most correct alternative: 05
The 90% confidence intervals for the ratios of both Cmax and
AUC should be contained within the
0.80-1.00 0.80-1.25 0.8-0.25 0.80-12.5
Bio-equivalence studies are in which each
subject acts as their own control.
Cross over parallel Factorial None of these
A 95% reference interval
contains the values for all healthy subjects.
will automatically exclude values for any subject who is ill.
is also known as a "normal range".
None of these
What does IRB stands for?
Institutional Review Board International Review Board
Investigational Review Board None of these
Which of the following is not an essential element of ethical
research?
Valuable scientific question
Balance of risks and benefits
Subject selection based on locality
Independent review
Fill in the blanks: 05
In single blinding study blinded to the
assignment treatment.
FDA is abbreviated of
Endpoints are the required
by the objectives.
Total number of phases in clinical trials are
EMA is abbreviated of
Page 1 of 2
State whether the following statement is true or false: 04
Run-In period acts as wash out period to remove effect of
previous therapy.
If two medicines are bioequivalent there is no clinically
significant difference in their bioavailability.
In randomization treatment assignment will be based on
patient's characteristics.
Preclinical studies are conducted on animals and artificial
cell in labs.
Q.2 Answer the following: 06
Explain the concept of direct and surrogate endpoints.
Explain the concept of block randomization.
Write short note on the following: 08
Objectives in clinical trials.
Placebo control trial.
Q.3 Explain the phases of clinical development in clinical trials. 07
Explain the concept of multicentre trial. 07
Q.4 What is blinding? Explain the various types of blinding. 07
Explain the concept of sample size determination in clinical
trials.
07
Q.5 Explain the Wilcoxon Sign rank test for single sample. When is
it useful in clinical studies?
07
Explain student's t-test and z-test. How is it useful in clinical
studies?
07
Q.6 What is bioequivalence? Describe the analysis of
bioequivalence study.
07
Explain the Cox's proportional hazard model for assessment of
test drug based on censored date.
07
Q.7 What is control group? Explain any two types of control group. 07
Describe the parallel design in clinical trials. 07