Best practices to determine fitness-for-purpose of RWE in oncology

In this week's Expert View, IQVIA's Matthew Reynolds, vice president of real world evidence and Jennifer Christian, VP & GM of medical & scientific services, provide insights into the best way to leverage real world evidence in the development of oncology therapeutics.

Real world evidence (RWE) continues to grow as a promising frontier in evidence generation to support positive health outcomes. It can be useful in evaluating unmet healthcare needs, real world standard of care, and patient-reported outcomes, as well as developing realistic trial designs and budget impact models.

As RWE is increasingly used for regulatory purposes, regulators are stressing the fitness-for-purpose assessments of data sources as an important factor for researchers to consider when designing their real world studies.

Evaluating fitness-for-purpose helps ensure the appropriateness and reliability of the data source selected to answer the specific research questions, and it enables regulators to confidently make decisions based on the evidence generated. Using a framework as a guideline can help researchers make the right choices to support acceptance of RWE by regulators.