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 for the non-credit course, click here.
Nurses employed by the FDA should register for the non-CE classroom. Information regarding applying for ANCC credits will be provided on request.
Registration Fees
CE: 6.0 AMA PRA Category 1 Credit™, 6.0 ACPE Contact Hours (0.6 CEUs)
Universal Activity Number (UAN): 0025-0000-21-122-H04-P
Activity Type: Application
Launch Date: 9/30/2021
Expiration Date: 9/30/2024
Course Number: COAS01-V2
Target Audience: Pharmacists, Physicians, and Researchers
Instructors:
- Katy Benjamin, MSW, SM, PhD, Director, Clinical Outcomes Assessment, AbbVie
- Laurie Burke, MPH, Affiliate Faculty of Pharmaceutical Health Services Research, University of Maryland School of Pharmacy; Founder/Principal, LORA Group
- Elisabeth Oehrlein, BA, MS, PhD, Assistant Vice President, Research & Programs, National Health Council
- Elektra Papadopoulos, MD, MPH, Acting Deputy Director of the Division of Clinical Outcome Assessment, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration
- John H. Powers, III, MD, FACP, FIDSA, Professor of Clinical Medicine, George Washington University School of Medicine
- Ashley Slagle, MS, PhD, Principal, 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.
The University of Maryland School of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
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.
Instructors
Katy Benjamin, MSW, SM, PhD
Director, Clinical Outcomes Assessment
AbbVie
Laurie Burke, MPH
Affiliate Faculty of Pharmaceutical Health Services Research, University of Maryland School of Pharmacy
Founder/Principal, LORA Group
Elisabeth Oehrlein, BA, MS, PhD
Assistant Vice President, Research & Programs
National Health Council
Elektra Papadopoulos, MD, MPH
Acting Deputy Director of the Division of Clinical Outcome Assessment, Office of New Drugs, Center for Drug Evaluation and Research
US Food and Drug Administration
John H. Powers, III, MD, FACP, FIDSA
Professor of Clinical Medicine
George Washington University School of Medicine
Ashley Slagle, MS, PhD
Principal
Aspen Consulting
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 ineligible organizations relevant to the content of the CPE activity. Any conflicts of interest identified are mitigated prior to presentation of the educational activity. Any off-label use of drugs or devices are disclosed during the activity. The instructors and contributors/advisors for this activity report no relevant financial relationships.
Disclosure and Transparency in CME/CPD:
It is MedChi’s policy to ensure the independence, transparency, balance, objectivity, scientific rigor and integrity, as well as validation of content for all CME/CPD activities we accredit. To that end, faculty must disclose to the participants any relationships with companies identified as meeting the ACCME definition of a commercial interest. In the process of the disclosure process, all faculty and planners have disclosed the presences or absence of such relationships to MedChi. MedChi has identified, evaluated and where appropriate, attempted to resolve any potential conflicts of interest. This is done through the use of content validation, the use of evidence-based data, and multi-disciplinary peer review. The information provided as disclosure to the learner, is to inform the learner and aide in judgment, not to imply that disclosed relationships will have a negative effect on a presentation.
Contributors/Advisors
- Wen-Hung Chen, PhD, GlaxoSmithKline
- Selena Daniels, PharmD, PhD, 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, BS, PhD, MS, University of Maryland School of Pharmacy
- Ester Villalonga Olives, PhD, MsC, University of Maryland School of Pharmacy
- Roxanne Zaghab, BA, MSW, DM, Principal and Senior e-Learning Advisor, Manage4Knowledge LLC
ACCME Information
Disclosure and Transparency in CME/CPD:
It is MedChi’s policy to ensure the independence, transparency, balance, objectivity, scientific rigor and integrity, as well as validation of content for all CME/CPD activities we accredit. To that end, faculty must disclose to the participants any relationships with companies identified as meeting the ACCME definition of a commercial interest. In the process of the disclosure process, all faculty and planners have disclosed the presences or absence of such relationships to MedChi. MedChi has identified, evaluated and where appropriate, attempted to resolve any potential conflicts of interest. This is done through the use of content validation, the use of evidence-based data, and multi-disciplinary peer review. The information provided as disclosure to the learner, is to inform the learner and aide in judgment, not to imply that disclosed relationships will have a negative effect on a presentation.
Accreditation Statement:
This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of MedChi, The Maryland State Medical Society and the University of Maryland School of Pharmacy. MedChi is accredited by the ACCME to provide continuing medical education for physicians.
Designation Statements:
The Science of Clinical Outcome Assessment (COA) in Medical Product Development—An Intensive Online Educational Series
MedChi designates this live educational activity for a maximum of 6.0 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
CME Credit: In order to receive CME credit for participation in these modules the learner is required to complete each test and achieve a score of 70% or higher for each module
Technology Requirements
Unless otherwise noted in the course materials, the following are required to access online courses: A computer or mobile device with a stable internet connection and the ability to view and update Microsoft Word® and PowerPoint® documents.
| Supported Internet Browsers |
Windows
- Internet Explorer version 11 and above
- Chrome 43 and above
- Firefox 4.0 (or later)
MacOS
- Safari 13 and above
- Chrome 43 and above
|
| Minimum Memory |
8 GB (or more) |
| Minimum Storage |
6 GB (or more) |
| Minimum Processor |
PC: 2 GHz or faster Intel processor
MacOS: Multi-core Intel processor |
| Minimum Internet Speeds |
High speed internet connection |
| Other |
Participants must be able to play audio (either through speakers or headphones) as well as ability to open PDF files and view and edit Word, and PPT documents. |
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. Learners must complete the activity evaluation in order to receive CE credit. Learners have 90 days to complete the online series. Statements of CE Credit will be available electronically via CPE Monitor within sixty (60) days of completion of the activity.
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.
Refund Policy:
- 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.
- 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.
