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Oncology PROs: Limited Use Due To Small Trials, Fast Drug Development

 
• By Kate Rawson

Patient-reported outcomes in oncology clinical trials remain an infrequently used tool, despite acknowledgement by sponsors that the patient experience is important to measure – and encouragement from FDA officials to do so. The lack of PROs in oncology may be a byproduct of the fast pace of cancer drugs are developed in the U.S.: small trials and accelerated pathways.

The success of the Breakthrough Therapy designation is nowhere better demonstrated than in oncology drug development.

Breakthrough emerged from the oncology drug review process at the Food & Drug Administration, and the “all-hands-on-deck” approach to development and application review has been enthusiastically adopted by review teams...

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