Clinical Outcome Assessments To Be Developed Under US FDA Grants

The projects could help streamline rare disease drug development, along with the Rare Disease Cures Accelerator.

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The core clinical outcome measures would be publicly available for little or no cost. • Source: Shutterstock

The US Food and Drug Administration awarded several grants from its pilot program to develop publicly available standard clinical outcome assessments (COAs), which should help streamline drug development when completed.

FDA officials are interested in developing a core set of COAs that may be used across diseases to reduce development costs, as well as further integrate the patient voice into the process. A standard set of measures that would be pre-verified as acceptable in clinical trials could save the time and effort developing tools unique for each new drug

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