Randomization in Clinical Trials: Theory and Practice

W. F. Rosenberger, University Professor and Chairman, Department of Statistics, George Mason University (6 hours total)

  • Date:

    26 JUNE
    -
    27 JUNE 2018
     

  • Event location: Aula III, 2nd floor, Department of Statistics, Via Belle Arti1 41, Bologna

  • Type: Cycle 33 - Short courses and seminars

Day

Time

06/26

14.00 – 17.00

06/27

10.00-13.00


Short Course:  Randomization in Clinical Trials:  Theory and Practice

Instructor:  W. F. Rosenberger, University Professor and Chairman, Department of Statistics, George Mason University

Textbook:  Rosenberger WF and Lachin JM (2016). Randomization in Clinical Trials:  Theory and Practice.  Wiley, Hoboken, 2nd. edition.

Prerequisites:  Graduate-level probability and mathematical statistics course

Randomization is the cornerstone of the randomized clinical trial in medicine.  Randomization mitigates certain biases, such as selection bias, ensures comparability between treatment groups, and provides a basis for inference.  This short course will cover the basic theory and practice of randomization.

Outline:

I.  Introduction
            Why do we randomize?
            Sources of Bias

II.  Restricted Randomization
            K=2 treatments
            Unbalanced allocation
            K>2 treatments

III.  The Effects of Unobserved Covariates

IV.  Selection Bias

V.  Randomization Tests
            The randomization model
            Computation

VI.  Finding an Appropriate Restricted Randomization Procedure

VII.  Stratification

VIII.  Covariate-adaptive randomization

IX.  Response-adaptive randomization

 

As time permits, we will also explore inference for covariate-adaptive and response-adaptive randomization procedures.