FDA-AACR Workshop Examines the Practice and Promise of Real-world Evidence in Oncology

Building on advances in technology and analytical tools, real-world data (RWD) sources have attracted increasing interest as means to efficiently answer important clinical, research, and regulatory questions around oncology treatments and outcomes. RWD can come from a variety of sources, including medical claims data, electronic health records, patient-reported outcomes, and product or disease registry data. Real-world evidence (RWE) is clinical evidence generated from these data.

While the randomized controlled trial remains the gold standard for gathering clinical evidence for regulatory use, RWE can provide critical insights in situations where such trials may be difficult to complete. This is especially relevant in oncology, where personalized medicine approaches are leading to increasingly smaller patient populations that necessitate new strategies for efficient drug development.

Read More

Stakeholder Perspectives on Non-clinical Models for Immuno-Oncology Products

On September 6, 2018, the U.S. Food and Drug Administration (FDA) and the American Association for Cancer Research hosted a public workshop, Non-clinical Models for Safety Assessment of Immuno-Oncology Products. Academics, industry, regulators, and biomedical research funders gathered to review the state of the science and discuss opportunities to develop better non-clinical approaches for safety assessment and dose selection for immuno-oncology products in patients, with specific focus on immune checkpoint stimulators and inhibitors (ICS/ICI).

Read More