The Science of Clinical Outcome Assessment (COA) in Medical Product Development - An Intensive Online Educational Series

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Overview / Abstract:

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).

Professionals can earn CEUs or take as a non-credit course.

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.

CE: 6.0 AMA PRA Category 1 Creditâ„¢, 6.0 ACPE Contact Hours
Universal Activity Number (UAN): 0025-0000-18-105-H04-P
Launch Date: 9/30/2018
Expiration Date: 9/30/2021
Course Number: COAS01
Target Audience: Pharmacists, Physicians, and Researchers


Sep 21, 2021


Pharmacy CPE, Physician CME



Credits / Hours




Presenters / Authors / Faculty

Katy Benjamin, PhD, MSW
Director, HEOR-PRO

Laurie Burke, MPH, BS
Affiliate faculty of Pharmaceutical Health Services Research
University of Maryland School of Pharmacy
LORA Group

Elizabeth Oehrlein, PhD, MS
Senior Director of Research
National Health Council

Elektra Papadopoulos, MD, MPH
Associate Director COA Staff, Office of New Drugs

John H. Powers, III, MD, FACP, FIDSA
Professor of Clinical Medicine

Ashley Slagle, PhD
Aspen Consulting

Activity Specialities / Related Topics

Research, Administration / Management

Keywords / Search Terms

University of Maryland School of Pharmacy: CIPS Knowledge Enterprise Clinical Trials, Food and Drug Administration, FDA, Outcomes, Research

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