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The Fundamentals of Real World Evidence in Oncology Drug Development


Real world evidence (RWE) provides a large and growing source of insights into drug uptake and safety. It is increasingly used in pricing and reimbursement negotiations and to support post-approval label expansions. In oncology where conditions are increasingly defined by genotype, there is a greater opportunity for RWE to facilitate regulatory approvals.

As more payers and HTA agencies turn to real world data to compare the effectiveness of various treatment effects, we need to assess how to use RWE to determine whether there is an unmet need that a new therapy can fulfill. In this final Winter Weekend Blog, we bring you an eBook that explores the full potential of real world data for Research and Development.

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


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