Planning Adaptive Studies with a Group Sequential Design

Adaptive Studies, or studies that use data collected during the study to modify one or more aspects of the study, are increasing in frequency with the publication of formal regulatory guidance on their conduct.   Adaptive study types are varied, making appropriate planning techniques for a specific adaptive trial plan unsuitable for another adaptive study.  In the ClearTrial system, there are general techniques that can be applied to planning different types of adaptive studies.

After completing the course, you will be able to:

1. Describe key considerations, benefits, and challenges in adaptive trial design

2. Use adaptive design in acute indications

3. Implement effective planning considerations essential in utilizing an adaptive trial design

The course is intended for clinical and financial professionals with at least three months’ experience (on a regular basis) with the ClearTrial software.

Prerequisite: 100-PLN1