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Useful for CSIR NET · ASRB NET · ISS

COURSE OVERVIEW

This course provides a comprehensive treatment of the statistical principles and methods used in the design, conduct, and analysis of clinical trials. Beginning with the ethical and regulatory framework, it progresses through sample size determination, trial design, categorical and survival analysis, and concludes with surrogate endpoints and meta-analysis. The emphasis is on the statistical reasoning that underpins every stage of a clinical trial — from protocol development to final reporting.

Course Outcomes

After successful completion of this course, the student will be able to:

  1. Acquaint with the need and ethics of clinical trials.
  2. Determine the appropriate sample size for different population sizes and response types.
  3. Understand and work with dichotomous and continuous response variables in clinical settings.
  4. Design various types of clinical trials including Phase I–IV, parallel, cross-over, and bioequivalence studies.
  5. Perform statistical analysis and report writing for clinical trial data.

Units at a Glance

Unit 1

Introduction to Clinical Trials

Need and ethics, bias and random error, Phase I–IV trials, multi-center trials, data management, CRFs, GCP.

 Unit 2

Determination of Sample Size

Sample size for dichotomous response, continuous response, and repeated measures variables.

 Unit 3

Design of Clinical Trials

Parallel vs. cross-over, cross-sectional vs. longitudinal, Phase I–III designs, sequential stopping, bioequivalence trials.

 Unit 4

Reporting and Analysis

Analysis of categorical outcomes, analysis of survival data from clinical trials.

 Unit 5

Surrogate End Points and Meta-Analysis

Selection and design with surrogate endpoints, analysis of surrogate endpoint data, meta-analysis of clinical trials.

 Practical

Lab Experiments

Sample size determination, logistic regression, crossover and parallel design analysis, meta-analysis.

Prescribed Textbooks & References

Next course in learning order: Statistical Techniques for Research Methodology Applied statistics