The primary purpose of clinical trials is to determine therapeutic benefit. Confirmatory studies further evaluate the effectiveness and safety of the drugs based on the results of the exploratory study, providing sufficient evidence for the approval of new drug applications. Having a deeper understanding of confirmatory studies is important to develop and implement an efficient clinical development plan.
This module introduces the value of these confirmatory trials in the lifecycle of clinical trials and shows how to formulate a holistic clinical development strategy that gives special consideration to confirmatory studies.
- Learn the key concepts of confirmatory research
- Understand the impact of confirmatory studies on late-stage clinical development strategy
- Core knowledge of confirmatory research
- Regulatory requirements
- Late-stage clinical development strategy
- Integrating confirmatory research in overall clinical development plan (CDP)
- Manage late-stage clinical research according to the target product profile (TPP) and CDP