Planning Extension Studies

Extension studies are used as a means for collecting rigorous information on long-term safety and tolerability data of a new drug prior to regulatory approval. Enrollment into an extension study typically follows enrollment into a randomized, blinded, well-controlled main study. Ideally both are planned at the same time.  At the time they are recruited into the main study, participants are usually informed that they may elect to enroll in an extension study after completing the main trial.

After completing the course, you will be able to:

1. Discern the characteristics of an extension study from other clinical studies

2. Use the "portfolio" and "compare" features to view the total costs and resource requirements associated with the main and extension phases of the study

3. Appropriately model the main and extension phase of a study including:

•   Assignment and inclusion of tasks and sub-tasks
•   Review of timelines and budget details

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