The Science of Clinical Outcome Assessment (COA) in Medical Product Development—An Intensive Online Educational Series
The Science of Clinical Outcome Assessment (COA) in Medical Product Development—An Intensive Online Educational Series is organized by University of Maryland School of Pharmacy (UMSOP).
Launch Date: 9/30/2021
Expiration Date: 9/30/2024
Description:
Clinical outcome assessments (COAs) are the tools used to assess clinical outcomes (i.e., how a patient feels, functions in day-to-day life, or survives) and are fundamental in establishing evidence of clinical benefit in medical-product development. Training in the science of clinical outcome assessments has been largely limited to academic degree programs hosted by universities.
The objective of this online COA continuing education (CE) series is to introduce COA fundamentals to working professionals in the area of medical-product development. The accessible format supports those seeking greater knowledge and skills in the emerging science of COA. Learners will include staff from government agencies (e.g., FDA and CMS), the biopharmaceutical industry, consulting companies, (e.g., clinical research organizations), and academia (faculty and graduate students).
Learning Objectives:
At the end of this application-based activity, the learner should be able to:
• Recognize and define terms used in Clinical Outcome Assessment (COA) in medical product development, including measurement types and instrument properties;
• Apply the principles of the FDA Roadmap to Patient-Focused Outcome Measurement and COA Framework in the assessment of one or more COA measurement strategies in medical product development; and
• Differentiate from among clinician-reported outcomes, observer-reported outcomes, performance outcomes, and patient-reported outcomes and the appropriate uses for each.
