M.Sc. (Semester IV) (CBCS) Examination Nov/Dec-2018
Statistics
CLINICAL TRIALS
Time: 2½ Hours Max. Marks: 70
Instructions: Attempt five questions.
Q. No. and Q. No. are compulsory.
Attempt any three questions from Q. 3 to 7.
Figures to the right indicate full marks.
Q.1 Select the most correct alternative. 05
The number of patients/volunteers involves in phase I
60-80 20-30
100-300 1000-1200
What does SOP stands for?
Statement of Purpose
Statement of Position
Standard Operating Procedure
None of the above
In single blind study is blinded to the assignment of the patient
to test group.
Patient Investigator
Both a and b a or b
Total number of phases in clinical trials are
One Two
Three Four
What does GCP stands for?
Ground Control Point Global Consciousness Project
Good Clinical Practice Global Carbon Project
Fill in the blanks. 05
The period between administration of reference drug and test drug is
called
is effective tool to prevent the selection bias.
acts as wash out period to remove effect of previous therapy.
ICH is abbreviated of
A new drug molecule is first tested on
State whether the following statement are True or False. 04
Protocol is a formal documentation that specifies how a clinical trial is to
be conducted.
Bioequivalence studies are conducted to compare a generic drug with
marketed formulation.
Phase I trials aim to compare the effect newer drugs with the standard
treatment.
A reference product is a pharmaceutical product with which the new
product is intended to be interchangeable in clinical practice.
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SLR-VR-500
Q.2 Answer the following. 08
Explain the concept of randomization.
What is control group? Explain any two types.
Explain the following terms. 06
No treatment control
Dose response control
Q.3 What are the ethical principles of clinical trials? 07
How are clinical trials supported? 07
Q.4 In which situation of analysis of clinical trials, the Kruskal-Wallis test is useful? 07
Explain the cross-over design used in clinical trials. 07
Q.5 Describe the responsibilities of different regulatory agencies in clinical trial. 07
What is ANOCOVA? In which situation of analysis of clinical trial ANOCOVA is
useful?
07
Q.6 Explain the importance of survival analysis in clinical trial? Explain Cox's
proportional Hazard model for assessment of test drug based on censored
data.
07
Explain the pre-clinical development in clinical trials. 07
Q.7 Explain the concept of bioequivalence study in clinical trials. 07
Explain the process of protocol development in clinical trials? 07