M.Sc. (Semester IV) (CBCS) Examination Oct/Nov-2017
Statistics
CLINICAL TRIALS
Day Date: Monday, 27-11-2017 Max. Marks: 70
Time: 02.30 PM to 05.00 PM
Instructions: Question No. 1 and 2 are compulsory
Attempt any 3 questions from Q.No.3 to Q.No.7
Figures to the right indicate full marks.
Q.1 Choose the correct alternatives 05
Which one of the following characterizes phase I drug testing?
It may involve patients with different kinds of cancer.
It is limited to patients who have highly effective treatment
alternatives.
It uses a single dose level to ascertain response rates.
It always involves completely predictable toxicities.
To begin clinical research study it is mandatory to get approval from

Sponsor
Regulator
Regulators and ethics committee both
None of these
In a double blind clinical drug trial?
Each patient receives a placebo.
Each patient receives both treatments.
The patients do not know which treatment they are receiving.
The patients do not know that they are in a drug trial.
What does ICH stand for?
International Convention on Homogenization.
International Conference on Harmonization.
International Conference on Homogenization.
International Convention on Harmonization.
In a clinical trial of a drug to improve the survival rate following heart
attacks,
Cases receiving the drug should be matched with controls by age
and sex.
Subjects should be a random sample of patients from a large
population.
If possible, written informed consent should be obtained before
patients can be admitted to the trial.
Subjects should be told whether they are receiving the test drug or
not.
Page 2 of 2
SLR-MS-673
Fill in the blanks. 05
PMDA is abbreviated of
The phase IV study is also known as
If patients on study are unaware of the treatment then the blinding is
called
Survival time from onset of diagnosis is a example of endpoint.
The is a formal document specifying how a clinical trial is to be
conducted.
State whether following statements are true or false: 04
Clinical trial will accept only sick people.
The primary objective of active control trial could be to establish the
efficacy of test drug.
In phase I NCE is tested for safety only.
The endpoint used in clinical trial must correspond to the scientific
objectives.
Q.2 Write short note on following:
Protocol and protocol development 08
Explain the concept of bias in clinical trial
Explain the following terms: 06
Active control trial
Placebo control trial
Q.3 Explain the overall new lead discovery in clinical research. 07
Describe precision analysis for sample size determination. 07
Q.4 What is randomization? Explain various types of randomization. 07
What are clinical trials? How are trials set up? 07
Q.5 Explain the role of statistician in clinical trials. 07
Explain the Kruskal-Wallis test. In which situation of analysis of clinical
trials it is useful?
07
Q.6 Describe factorial design used in clinical trial. 07
Explain Kaplan-Meier method for estimating survival curve. 07
Q.7 Describe the concept of bioequivalence trial. 07
What are the advantages of multicenter trial over single site study? 07