Clinical Research Design and Applied Biostatistics

• Q1.What happens to minimum sample size when range of allowable error is doubled?

  • AReduced to 1/2
  • BReduced to 1/4
  • CReduced to 1/16
  • DSample size does not depend on acceptable error
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• Q2.All of the following are true regarding increasing sample size except:-

  • ADecreases power of test
  • BStandard error of mean decreases
  • CDecrease in Confidence interval
  • DDecreases alpha error
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• Q3.The number of patients required in a clinical trial to treat a specify disease increases as

  • AThe drop-out rate increases
  • BThe significance level increases
  • CThe size of the expected treatment effect increased
  • DThe incidence of the disease decreases
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• Q4.You have been asked to design a study for a disease whose prevalence in the community is 10%. The alpha error has to be kept at 5% with a relative precision of 20% and a power of 20%. What will be the accurate sample size for this study?

  • A400
  • B900
  • C1800
  • D3600
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• Q5.Regarding Evidence Based Medicine (EBM), all of the ing arc true, except:

  • AEBM depends on clinical model and decision analysis to base its recommendations
  • BEBM objectively evaluates the quality of clinical research by critical assessing techniques repoed by researchers in publications
  • CThe strongest argument for the therapeutic intervention is systemic review or meta-analysis of triple blinded, randomized, placebo-controlled clinical trials with allocation concealment and complete follow-up involving a homogenous population of patients or medical disorders
  • DThe weakest argument is the opinion of expes or medical boards
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• Q6.A clinical trial was conducted with 15225 hypertensive patients alloted in the intervention group (New drug) and control group (Old drug) respectively. Results of the research study are given in the following table. Calculate the absolute risk reduction (ARR) and relative risk (RR): Control group (old drug)Intervention group (new drug)Developed HT complications18001620Did not develop HT complications1342513605Total subjects1522515225

  • AARR = 10% and RR = 0.9
  • BARR = 1% and RR = 9
  • CARR = 1% and RR = 0.9
  • DARR = 10% and RR = 9
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• Q7.The prevalence of disease in a population is expected to be 50%. An investigator is interested in the range of 45 to 55% with 95% confidence. The minimum sample size required for the study is:

  • A100
  • B200
  • C300
  • D400
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• Q8.Kaplan Meier method is used for:

  • APrevalance
  • BSurvival
  • CFrequency
  • DIncidence
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• Q9.All are True regarding Meta-analysis except:

  • AThe validity does not depend on quality of systemic review
  • BIts purpose is not to identify risk factors
  • CPurpose is to increase statistical power by increasing the sample size
  • DStatistical technique for combing the findings from several independent studies on special topic
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• Q10.L-J chart is used for monitoring -a) Accuracyb) Precisionc) Sensitivityd) Specificity

  • Aac
  • Bab
  • Cad
  • Dbc
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Answer key

Q1: B. Reduced to 1/4; Q2: A. Decreases power of test; Q3: A. The drop-out rate increases; Q4: B. 900; Q5: A. EBM depends on clinical model and decision analysis to base its recommendations; Q6: C. ARR = 1% and RR = 0.9; Q7: D. 400; Q8: B. Survival; Q9: A. The validity does not depend on quality of systemic review; Q10: C. ad.

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• Disease Concepts and Levels of Prevention
• Epidemiological Principles
• Descriptive Study Designs
• Analytical Study Designs: Case-Control and Cohort
• Experimental and Trial Designs
• Core Terminology in Infectious Disease Epidemiology
• Disease Transmission Dynamics
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• Disinfection and Sterilization Methods
• Screening
• Respiratory Infections of Viral Origin
• Respiratory Infections of Bacterial Origin
• Enteric and Intestinal Infections
• Arthropod-Transmitted Infections
• Viral Zoonoses
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• Sexually Transmitted and Surface Infections
• Cardiovascular Disease and Diabetes
• Cancer, Obesity and Blindness
• National Health Programmes: NVBDCP
• National Health Programmes: NLEP, NTEP and NACO
• National Health Programmes: NIS, JSY, RBSK and Others
• Demographic Cycle, Growth Rate and Age Pyramid
• Demographic Indicators
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• Mosquitoes and Flies as Disease Vectors
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• Pest and Vector Control Measures
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• Health Education and Communication Methods
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