Clinical

FDA, Friends identify next steps for dose optimization, pragmatic trials, academic-led studies for drug approvals

FDA, Friends identify next steps for dose optimization, pragmatic trials, academic-led studies for drug approvals

To improve evidence generation in studies designed to bring therapeutic agents to market, FDA is urging drug sponsors not to skip dose optimization at the outset of clinical development. The agency is also telling industry that it’s open to accepting trials that have pragmatic elements and are augmented by data generated in academia.
Real-world tumor response rate can serve as a clinical endpoint, Friends pilot study shows
Real-world Evidence

Real-world tumor response rate can serve as a clinical endpoint, Friends pilot study shows
FDA says raw images enrich the data when used with clinician assessments

A novel study led by Friends of Cancer Research is providing evidence that tumor response rates can be assessed across real-world data sets, bringing regulators one step closer to potentially building a framework for pre-market evaluation of cancer drugs and post-market tracking of drug performance based on real-world endpoints.