PHT Releases App for Navigating FDA Guidelines on Patient-Focused Outcomes
May 15, 2014 | The FDA Roadmap App from PHT Corporation is built to help sponsors design clinical trials around patient-reported outcomes in compliance with FDA recommendations. While measuring outcomes that matter to patients is an increasingly popular route to FDA approval and market differentiation, the agency's guidelines on which patient-reported outcomes should be considered as potential trial metrics are complex and context-dependent. The FDA Roadmap App, which this week became available on Apple as well as Android products, walks sponsors through the process of choosing, collecting and monitoring these metrics.
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