Healthcare Economist July 5, 2022
Jason Shafrin

FDA wants drugs to be more targeted to factors that impact patient’s lives in ways that they care about. To achieve this goal, last month FDA released a third guidance document on patient focused drug development generally applicable to a variety of clinical outcome assessments (COAs), including patient-reported outcome (PRO), observer-reported outcome (ObsRO), clinician-reported outcome (ClinRO), and performance-based outcome (PerfO) measures.

  • Patient reported outcomes (PRO). Reports come directly from the patient. These measures are useful for assessment of symptoms (e.g., pain intensity, shortness of breath), functioning, events, or other aspects of health from the patient’s perspective. Often PROs are collected through questionnaires, but increasingly are being collected using digital health technologies (DHTs).
  • Observer-reported outcomes (ObsRO). Reports come from someone other than...

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Topics: Biotechnology, FDA, Govt Agencies, Patient / Consumer, Pharma, Pharma / Biotech
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