Course Summary

In clinical trials, endpoints are measurements to evaluate the results of a new treatment, at an individual patient level. The study data can be extrapolated to patient populations on the basis of clinical similarities to patients participating in the trial. When clinical trial data have been obtained, focus is on the trial endpoints; more specifically, the focus is on whether the trial met or failed the primary endpoint specified before the trial started. The purpose and various types of endpoints 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

• Define clinical endpoints
• Describe the main categories of endpoints
• Identify the differences between primary and secondary endpoints
• Outline the importance of clinical relevance

Module Outline

Key topics covered in this module include:

• clinical endpoints;
• types of endpoint;
• clinical relevance;
• quality of life; and
• assessing efficacy.

Assessment - Multiple-choice assessment.