IGNOU MSCAST MST 19 Epidemiology and Clinical Trials Solved Assignment ENGLISH

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MST 019 (January 2026 - July 2026) - ENGLISH

TUTOR MARKED ASSIGNMENT
MST-019: Epidemiology and Clinical Trials
Course Code: MST-019
Assignment Code: MST-019/TMA/2025
Maximum Marks: 50
Note: All questions are compulsory. Answer in your own words.

1. (a) In the natural history of a disease define total preclinical phase, detectable pre-clinical phase and clinical phase. Suppose on 09 am on 25.01.2024 a disease A onset you biologically. Suppose a test of disease A can detect it exactly after the completion of 30 days of biological onset. Suppose signs and symptoms develop exactly after the completion of 34 days of
biological onset. Suppose you consult a doctor exactly after 37 days of the biological onset of the disease. Suppose the outcome of the treatment is the cure. What is the duration of the (i) total preclinical phase (ii) detectable pre-clinical phase (iii) clinical phase?
(b) If p denotes proportion and q denotes odds then prove that . Find the range of q. If the odds of smokers in a study are 0.75 then find the proportion of smokers in the study. Assume that each subject of the study is either a smoker or a non-smoker.

(c) A trial is conducted in which some people with disease X were randomly allocated into two groups. The first group was advised to do some morning walks for 30 minutes and take light food each day and the second group was given one injection and one 100 mg tablet once a day to control disease X. The injection can cause loose motion in some cases and 100 mg tablet has no side effect. At the end of two months, 90% of group I and 80% of group II had recovered from disease X.

    i) What are the regimens for group I and group II in this trial?

    ii) What are the efficacies in group I and group II?

    iii) What are the safety issues in group I and group II in this trial?

2. Explain the entire procedure of any one of the three study designs (a) Cross Sectional (b) Cohort (c) Case Control.

3. If you are told that hemoglobin (Hb) level in blood measures the iron content. The normal level in healthy people is around 15 g/dL. Most Indian women have less and some have even less than 8 g/dL. They are called anemic. Iron supplementation is given to increase this level. Suppose one supplementation increases the mean Hb level in anemics by 3.2 g/dL, after one month of use and the other by 3.6 g/dL, in an equivalence trial on 500 women each. The respective SD’s of the of the increases are 0.52 and 0.72 g/dL. The doctors determine that the supplementations can be clinically equivalent if the difference between the increases by the two supplementations does not exceed 0.52 g/dL. Can these two supplementations be considered clinically equivalent at 5% level of significance?

 

MST 019 (January 2025 - July 2025) - ENGLISH

TUTOR MARKED ASSIGNMENT

MST-019: Epidemiology and Clinical Trials

Course Code: MST-019

Assignment Code: MST-019/TMA/2025

Maximum Marks: 50

Note: All questions are compulsory. Answer in your own words.

1. (a) In the natural history of a disease define total preclinical phase, detectable pre-clinical phase and clinical phase. Suppose on 09 am on 25.01.2024 a disease A onset you biologically. Suppose a test of disease A can detect it exactly after the completion of 30 days of biological onset. Suppose signs and symptoms develop exactly after the completion of 34 days of biological onset. Suppose you consult a doctor exactly after 37 days of the biological onset of the disease. Suppose the outcome of the treatment is the cure. What is the duration of the (i)total preclinical phase (ii) detectable pre-clinical phase (iii) clinical phase?

(b) If p denotes proportion and q denotes odds then prove that  Find the range of q. If the odds of smokers in a study are 0.75 then find the proportion of smokers in the study. Assume that each subject of the study is either a smoker or a non-smoker.

(c) A trial is conducted in which some people with disease X were randomly allocated into two groups. The first group was advised to do some morning walks for 30 minutes and take light food each day and the second group was given one injection and one 100 mg tablet once a day to control disease X. The injection can cause loose motion in some cases and 100 mg tablet has no side effect. At the end of two months, 90% of group I and 80% of group II had recovered from disease X.

i) What are the regimens for group I and group II in this trial?

ii) What are the efficacies in group I and group II?

iii) What are the safety issues in group I and group II in this trial?

2. Explain the entire procedure of any one of the three study designs (a) Cross Sectional (b) Cohort (c) Case Control.

3.If you are told that hemoglobin (Hb) level in blood measures the iron content. The normal level in healthy people is around 15 g/dL. Most Indian women have less and some have even less than 8 g/dL. They are called anemic. Iron supplementation is given to increase this level. Suppose one supplementation increases the mean Hb level in anemics by 3.2 g/dL, after one month of use and the other by 3.6 g/dL, in an equivalence trial on 500 women each. The respective SD's of the of the increases are 0.52 and 0.72 g/dL. The doctors determine that the supplementations can be clinically equivalent if the difference between the increases by the two supplementations does not exceed 0.52 g/dL. Can these two supplementations be considered clinically equivalent at 5% level of significance?

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