Survival Analysis and Clinical Trials

Paper Code: 
STT 423(C)
Credits: 
5
Contact Hours: 
75.00
Max. Marks: 
100.00
Objective: 

This course focuses on statistical methods for discrete data collected in public health, clinical and biological studies including survival analysis. This would enable the students to understand the principles of different statistical techniques useful in public health and clinical studies conducted.

 

Students will able to

Course

Learning outcomes (at course level

Learning and teaching strategies

Assessment Strategies

 

Paper Code

Paper Title

STT-423(C)

Survival Analysis and Clinical Trials

CO 110: Easily identify the distribution of data.

 

CO 111: Have much more knowledge of biological data.

 

CO 112: Analyze the data through appropriate techniques.

 

CO 113: Cope-up with the data related to medical sciences and life sciences statistically.

Approach in teaching:

Interactive Lectures,

Group Discussion,

Classroom Assignment

Problem Solving Sessions

 

Learning activities for the students:

Assignments

Seminar

Presentation

Subject based  Activities

Classroom Quiz

Assignments

Class Test

Individual Presentation

 

15.00
Unit I: 
UNIT I

Concepts of Time, Order and Random Censoring. Life distributions - Exponential Gamma, Weibull, Lognormal, Pareto, Linear Failure rate. Parametric inference Point estimation, Confidence Intervals, Scores, tests based on LR , MLE

 

15.00
Unit II: 
UNIT II

Life tables, Failure rate, mean residual life and their elementary properties. Ageing classes -IFR, IFRA, NBU, NBUE, HNBUE and their duals, Bathtub Failure rate. Estimation of survival function - Actuarial Estimator, Kaplan - Meier Estimator, Estimation under the assumption of IFR/DFR.

 

 

15.00
Unit III: 
UNIT III

Tests of exponentially against non-parametric classes - Total time on test, Deshpande test. Two sample problem - Gehan Test, Log rank test. Semi-parametric regression for failure rate - Cox's proportional hazards model with one and several covariates.

 

15.00
Unit IV: 
UNIT IV

Clinical trials: introduction, need and ethics , bias and random error, conduct of clinical trials. Overview of phase I-IV trials, multicenter trials. Data management: data definition, case report forms, database design, data collection system.

 

15.00
Unit V: 
UNIT V

Planning and Design of clinical trials: parallel vs cross over design, cross sectional vs longitudinal designs, Phase I, II, and III trials. Consideration in planning a clinical trial,. Analysis of categorical outcomes o Phase I, II, and III trials, analysis of survival data from clinical trials.

 

Essential Readings: 
  • Cox, D.R. and Oakes, D. (1984). Analysis of Survival Data, Chapman and Hall, New York.
  • Gross, A. J. and Clark, V. A. (1976). Survival Distributions: Reliability Applications in the BiomedicalSciences, John Wiley and Sons.
  • Elandt - Johnson, R.E., Johnson, N.L. (1980). Survival models and Data Analysis, John Wiley and Sons.
  • Miller, R.G. (1981). Survival Analysis, Wiley.
  • Collett, D. (2003). Modelling Survival Data in Medical Research, Chapman & Hall/CRC.
  • Ewens, W. J. and Grant, G.R. (2001). Statistical methods in Bio informatics: An Introduction, Springer.
  • Friedman, L.M., Furburg, C. and DeMets, D.L. (1998). Fundamentals of Clinical Trials,
  • Springer Verlag.
  • Miller, R.G. (1981). Survival Analysis, John Wiley & Sons.
  • Robert F. Woolson (1987). Statistical Methods for the analysis of biomedical data, John Wiley & Sons.

 

Academic Year: 
2021-2022
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