The Science of Clinical Outcome Assessment (COA) in Medical Product Development—An Intensive Online Educational Series
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. To register in thecredit course, click here.
Registration in the non-CE classroom is open to federal employees only. To register for the non-CE rate, learners must use their federal government email during the registration process. Registrations submitted without a federal government email address may be subject to cancellation without a refund to the learner. To receive CE credits, register here.
Nurses employed by the FDA should register for the non-CE classroom. Information regarding applying for ANCC credits will be provided on request.
Contact Hours: 6.0 Hours
Course Number: COAS01
Target Audience: Pharmacists, Physicians, and Researchers
- Katy Benjamin, PhD, MSW, Director, HEOR-PRO, AbbVie;
- Laurie Burke, MPH, BS, Affiliate faculty of Pharmaceutical Health Services Research, University of Maryland School of Pharmacy and Founder/Principal, LORA Group
- Elisabeth Oehrlein, PhD, MS, Senior Director of Research, National Health Council
- Elektra Papadopoulos, MD, MPH, Associate Director COA Staff, Office of New Drugs, USFDA
- John H. Powers, III, MD, FACP, FIDSA, Professor of Clinical Medicine, GWU-SOM
- Ashley Slagle, PhD, Consultant, Aspen Consulting
This project was made possible by Grant Number U01FD005946 from the FDA, which supports the University of Maryland Center of Excellence in Regulatory Science and Innovation. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the HHS or FDA.
At the end of this practice-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.
Katy Benjamin, PhD, MSW
Laurie Burke, MPH, BS
Affiliate faculty of Pharmaceutical Health Services Research
University of Maryland School of Pharmacy
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
Conflict of Interest Disclosure: It is the policy of the University of Maryland School of Pharmacy Office of Continuing Pharmacy Education to ensure balance, independence, objectivity, and scientific rigor in all of its educational activities. In accordance with this policy, all persons in a position to control activity content of continuing pharmacy education activities must disclose their financial relationships with commercial interests relevant to the content of the CPE activity. Any conflicts of interest identified are resolved prior to presentation of the educational activity. Any off-label use of drugs or devices are disclosed during the activity. The activity faculty made the following disclosures:
- Dr. Benjamin is employed by AbbVie Pharmaceuticals
- Ms. Burke has nothing to disclose
- Dr. Oehrlein has received research funding from Pfizer, Inc.
- Dr. Papadopoulos has nothing to disclose
- Dr. Powers is a consultant for Corbus, Gilead, Janssen, and Romark
- Dr. Slagle is a consultant for multiple pharmaceutical companies
Disclosures of the faculty and planning committee members are noted for all learners in the designated section of each educational module. No product-specific discussions are contained in these modules.
- Wen-Hung Chen, PhD, US Food and Drug Administration
- Selena Daniels, PharmD, MS, US Food and Drug Administration
- Kathleen Dury, University of Maryland School of Pharmacy
- Rosie Love, MPH, University of Maryland School of Pharmacy
- Elektra Papadopoulos, MD, MPH, US Food and Drug Administration
- Eleanor Perfetto, PhD, MS, University of Maryland School of Pharmacy
- Ester Villalonga Olives, PhD, MsC, University of Maryland School of Pharmacy
- Roxanne Zaghab, MSW, DM, CKM, University of Maryland School of Pharmacy
To access the course materials, you must use a computer with an internet connection and an online browser that supports the Adobe® Flash® Player version 10. Mozilla® Firefox, Windows Internet Explorer 9 or higher, or Apple® Safari® for desktop are acceptable browsers.
Successful Completion: The participant must complete all activity components including the audiovisual presentations, tests, and an activity evaluation. Participants must receive a score of at least 70% on each of the tests in order to receive CE credit. The tests may be taken up to three (3) times each. A link to the activity evaluation will be available once a learner has successfully completed all other course segments.
Privacy and Confidentiality:
University of Maryland School of Pharmacy is committed to protect the privacy of our learners. All enrollees are protected under The Family Educational Rights and Privacy Act (20 U.S.C. § 1232g; 34 CFR Part 99) (FERPA). The UMB Policy on Confidentiality and Disclosure of Student Records can be found at: https://www.umaryland.edu/policies-and-procedures/library/academic-affairs/policies/iii-630a.php.
In order to submit your continuing education credit to a professional accrediting body, we must to collect the information below. When you request continuing education credits, certain personal information will be provided to the professional certifying entity in order to issue Certificates of Credit.
Copyright: Resources are provided for the educational benefit of our learners and are not for distribution. All information and materials provided are the property of and have been prepared by the University of Maryland Baltimore or have been granted permission for use by the copyright owner. No portion of this module may be reproduced or transmitted without written permission. All rights reserved.
The University of Maryland School of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
- A refund, less a $75 administration fee, will be made if cancellations are requested within 15 days. Other restrictions may apply.
- Refund requests must be submitted in writing to CEHelp@rx.umaryland.edu.
- Refunds are not available in the following circumstances:
- A learner has logged into a course or series;
- Has launched course materials;
- Course materials have been shipped; or
- Request is made after 15 days of the ordering date.
- Registration in the Non-CE classroom is restricted to FDA employees only. Learners must use their FDA email during the registration process. Registrations submitted without an FDA email address will be cancelled without a refund to the learner.
- Course registrations are non-transferrable.
Questions? Review the Frequently Asked Questions page. Can't find what you are looking for? Contact Customer Service at CEHelp@rx.umaryland.edu or 410-706-3381.