US FDA Cancer Drug Dosage Optimization Guidance Will Increase Exposure To Ineffective Agents, NCI Says

 
• By Sue Sutter

Draft recommendations would lead to enrolling additional patients on multiple dose levels to assess activity before clinical effectiveness has been established, National Cancer Institute says; industry cites need for flexibility in recommending randomized studies of multiple dosages and questions utility of PRO data in early dose finding studies.  

Population growth
National Cancer Institute says new FDA draft guidance will subject a substantial number of additional patients to dose optimization studies of ineffective or non-viable agents. • Source: Shutterstock

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