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Patient-Focused Drug Development Guidance: Determining When A Clinical Outcome Assessment Is Appropriate

 
• By Brenda Sandburg

A US FDA draft guidance on selecting and developing fit-for-purpose clinical outcome assessments specifies the evidence that can be provided to support using a COA in a particular context.

clinical assessment
The US FDA issued draft guidance on clinical outcome assessments in patient-focused drug development. • Source: Shutterstock

Draft guidance issued by the US Food and Drug Administration provides a list of eight components of evidence that a sponsor can provide to show a specific clinical outcome assessment is expected to work in a particular study.

The guidance, Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-For-Purpose Clinical Outcome Assessments, addresses how to ensure that a...

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