Uses of real world data have played a role in every stage of clinical development from pre-clinical assessment of unmet need, to comparative effectiveness analysis for market access.
Challenges commonly faced by clinical development in oncology make methods involving real world evidence prized mechanisms for optimizing trial design. As Real World Evidence (RWE) in Oncology drug development grows, stay on top of the latest insights through Cytel’s new e-book. This e-book provides an overview of RWE uses for regulatory submission, providing an introduction to techniques and methods that might seem unfamiliar to those who work on Phase 1, 2 and 3 clinical studies.
This e-book will:
- Provide an overview of how RWE can support every stage of clinical development, and advance the needs of trial sponsors through rigorous data science
- Look at quantitative strategies to prepare for regulatory submission and thereafter, consider how RWE
can be used to understand patient preferences on different types of treatment, or construct formulations for market access
- Include case studies on various topics such as Synthetic and External Control Arms, Head- to Head studies, New Treatment Patterns, Survival Extrapolations and more