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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.

Construction framing
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 framework starts with...

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

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EMA Official Clarifies Benefits And Limitations Of Innovation Pathways

 
• By Eliza Slawther

A European Medicines Agency official provided an overview and update of the support the EMA offers developers of innovative products and discussed, among other things, its Innovation Task Force, Quality Innovation Group and a scientific advice pilot for clinical trials.

US FDA’s Prasad: ‘We Will Always Embrace Surrogate Endpoints’

 
• By Sarah Karlin-Smith

The new CBER director, once best known in the pharma world for criticizing accelerated approval, committed to expediting cancer drugs with surrogate endpoints.

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• By Vibha Sharma

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EMA: ‘Sad To See’ Member States Against Patient Engagement Under EU Pharma Reform

 
• By Eliza Slawther

The European Medicines Agency’s chief medical officer Steffen Thistrup argued that patients are able to understand the “complex regulatory and scientific issues” that the EMA committees discuss when they assess drugs.