Statistical Elements of Clinical Trials (CT04E)

Course Summary

Analytical statistical elements are essential concepts in the design of clinical trials. This analysis helps us to understand whether a conclusion from a study of a sample of the target population applies generally to that population as a whole. In particular, it helps us to answer the question: Did the treatment effect in the given study occur just by chance? The statistical elements of a well-controlled study minimise the chances of drawing the wrong conclusions, by providing clear thresholds for such errors. The basic statistical elements of a clinical trial include eligibility criteria, randomisation, sample size, power, and blinding, and these are discussed in this short course.

Who will benefit from this module?

This module is intended for all those involved in the preparation, design, conduct or analysis of clinical trials. It will be useful to new entrants to the field or as a refresher for staff, including clinical research associates and data managers, in the clinical/medical departments of pharmaceutical or biotechnology companies or in contract research organisations. It will also be of interest to clinical investigators, study coordinators, and other healthcare staff working on clinical trials.

Learning Objectives

• Identify the basic statistical elements of clinical trial design
• Define eligibility criteria as detailed in the ICH guideline for Good Clinical Practice
• Describe the concepts of randomisation and stratification
• Outline the information required to calculate sample size
• Explain the importance of blinding

Module Outline

Key topics covered in this module include:

• Eligibility criteria
• Randomisation and stratification
• Sample size
• Power and blinding
• Intention to treat

Assessment - Multiple-choice assessment.