Transforming Cancer Treatment: Impact of FDA Project FrontRunner on oncology drug development

White Paper

This whitepaper examines the FDA's initiatives toward encouraging earlier studies via Project FrontRunner, offering practical guidance on engaging with the FDA and leveraging accelerated approval pathways to expedite patient access to new therapies.

Jan 31, 2025

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Transforming Cancer Treatment: Impact of FDA Project FrontRunner on oncology drug development

This whitepaper explores the FDA's efforts to encourage earlier studies, highlighting their potential to sharpen our understanding of a treatment's effects, improve comparisons to standard care, and reduce the time it takes to bring effective new therapies to the clinic. We'll also look at what it takes to design robust randomized controlled trials (RCTs) that generate the high-quality evidence regulators expect, and illustrate these principles through a case study.

In addition, we'll consider practical guidance on engaging with the FDA early in the development process, leveraging accelerated approval pathways, and taking advantage of evolving guidance so that patients can benefit more quickly from groundbreaking treatments.

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