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Build Patient-Reported Outcomes Into Cancer Drug Dose Optimization, US FDA Says

 
• By Sue Sutter

In exploratory FDA analyses, PRO data appeared more sensitive at detecting an exposure-toxicity relationship for an oral small molecule cancer drug than clinician-reported data; Project Optimus representative dispels industry concerns that FDA wants firms to find the 'mythical' optimal dose.

Pie in the sky
The intent of dose optimization is not to achieve a 'mythical, pie in the sky' optimal dose, the FDA says. • Source: Shutterstock

Adding patient-reported outcomes data to clinician-reported adverse events in early cancer drug trials could better inform dose selection and optimization, US Food and Drug Administration officials said at a recent meeting on optimizing dose selection strategies.

PROs often are included only in late-stage or registrational cancer trials, but it is both feasible and advantageous to measure...

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• By Francesca Bruce

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New UK Network Targets Speed And Inclusion For Commercial Clinical Trials

 
• By Vibha Sharma

The UK government expects that its new nation-wide network will enable companies to set up clinical trials more quickly and expand access to diverse patient populations across the National Health Service.

Oncology: Plan Ahead To Rule Out Harm When Survival Not The Endpoint, US FDA Says

 
• By Michael McCaughan

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Selective Safety Data Collection In Clinical Trials: Adoption Lags Despite Benefits, US FDA Says

 
• By Manas Mishra

Lack of awareness is limiting use of guidelines that simplify safety reporting for some late-stage trials, FDA says, while also highlighting wins. Boehringer experienced mixed results, while Novartis, Lilly, and Merck were more successful, and Roche should have probably tried, white paper suggests.