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Cancer Trials: US FDA Debuts Framework For Patient-Reported Tolerability Assessments

 
• By Sue Sutter

The agency wants sponsors to start with three core symptoms common across cancer therapeutics and then add more treatment-related adverse events from item libraries based on a drug’s mechanism of action and other factors.

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Oncology sponsors may want to use the FDA's new framework for determining the treatment-related symptoms to assess in clinical trials. • Source: Shutterstock

The US Food and Drug Administration is proposing a framework that oncology sponsors can customize to assess tolerability using patient-reported outcomes.

Key Takeaways

  • The FDA is proposing a framework that oncology sponsors can use to assess symptomatic adverse events through patient-reported outcomes.

The FDA’s Oncology Center of Excellence rolled out the framework at its recent annual workshop on clinical outcome assessments.

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Post-Approval, Real-Time Monitoring Will Help Approval Standards, US FDA’s Makary Says

 
• By Sue Sutter

The FDA will use electronic health records to “get eyes” on drugs immediately after approval, Commissioner Martin Makary told the DIA 2025 Global Annual Meeting. He also wants to reduce development time with better communication and new approval pathways.

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What UK’s Clinical Trials Overhaul Means For Orphan Drug Developers

 
• By Eliza Slawther

The UK government has acknowledged that sponsors of clinical trials for rare diseases face challenges around patient recruitment and trial design, which will be addressed in its clinical trials reform, a lawyer says.