Survival Analysis and Clinical Trials

Paper Code: 
24STT423(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.

 

Course Outcomes: 

Course

Course Outcomes

Learning and teaching strategies

Assessment Strategies

Course Code

Course Title

24STT423(C)

Survival Analysis and Clinical Trials

(Theory)

CO 142: Identify the key concepts of time, order, and random censoring within the context of reliability engineering.

CO 143: Classify different aging classes and analyze their properties in relation to failure rate.

CO 144: Apply Cox's proportional hazards model with covariates to semi-parametric regression for failure rate analysis.

CO 145: Evaluate the ethical considerations and biases involved in the conduct of clinical trials.

CO 146: Explain the differences between parallel and crossover designs in clinical trials and effectively plan Phase I, II, and III trials considering various factors.

CO 147: Contribute effectively in course-specific interaction.

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: 
Concepts of Censoring and Life Distributions

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: 
Life Tables and Estimation of Survival Functions

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: 
Non-Parametric Tests and Semi-Parametric Regression

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: 
Introduction to Clinical Trials and Data Management

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: 
Planning, Design, and Analysis of Clinical Trials

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 of 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.

 

SUGGESTED READINGS:

  • 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.

 

e-RESOURCES:

 

JOURNALS:

  • Sankhya The Indian Journal of Statistics, Indian Statistical Institute
  • Aligarh Journal of Statistics, Department of Statistics and Operations Research, Aligarh Muslim University
  • Afrika Statistika, Saint-Louis Senega University
  • International Journal of Statistics and Reliability Engineering, Indian Association for Reliability and Statistic
  • Journal of the Indian Society for Probability and Statistics, Indian Society for Probability and Statistics
  • Journal of the Indian Statistical Association, Indian Statistical Association
  • Statistica, Department of Statistical Sciences Paolo Fortunato, University of Bologna
  • Statistics and Applications, Society of Statistics, Computer and Applications
  • Stochastic Modeling and Applications, MUK Publications and Distributions

 

Academic Year: 
2024-2025
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