Electronic Clinical Outcome Assessment Consortium

Overview

The Problem

The critical need for accurately measuring the health status of clinical trial participants directly and without influence continues to rise in importance to both regulators and patients themselves. The ever-expanding use of electronic methods to capture patient-reported outcomes (PRO) and other clinical outcome assessment (COA) data, alongside passive, digitally derived data via digital health technologies (DHTs), has established technology as a powerful and multi-faceted tool in capturing the patient experience in medical and therapeutic development.

Alongside those technologies, there are a range of approaches taken by different stakeholders to justify use, implementation, and oversight of these systems, which introduces inefficiency and instability to the clinical trial process. Singular, siloed approaches that lack standardization, alignment with regulatory expectations, and adherence to established best practices present risks to trial execution and, ultimately, the development of new and effective medicines and treatments. There is a tangible need, recognized by regulators and electronic COA (eCOA) providers alike, to develop the standards, resources, education and best practices to drive efficient use of these systems.

The Solution

The eCOA Consortium is powered by providers of eCOA technologies and allied services who support the collection of COA and DHT-derived data in clinical trials. These industry leaders work in a pre-competitive environment in which a critical mass of experts can collaborate to develop standards, conduct research, design and deliver educational opportunities, and define the best practices for the electronic collection of COA and DHT-derived data. The eCOA Consortium serves the clinical research community as the definitive resource for authoritative, consensus-developed resources to support eCOA usage. The Consortium works closely with other stakeholders, such as clinical trial sponsors from the PRO Consortium and the Rare Disease COA Consortium and regulators, with the overarching aim of enhancing public health by optimizing the quality and value of COA/DHT-derived data in medical evaluation and clinical decision-making.

The Impact

The impact of the eCOA Consortium’s work is improved quality, practicality, and acceptability of electronic capture of clinical trial endpoint data. Since its inception in 2011, the eCOA Consortium members have produced, or collaborated with colleagues to produce, the following educational resources for sponsors and eCOA providers:

• Six best practices white papers
• 21 webinars
• 20 peer-reviewed publications
• 10 poster presentations
• 20 podium presentations

More information about these resources can be found here.

To learn more about eCOA, contact us at ecoac@c-path.org or subscribe to our updates here.

Resources

Publications/White Papers/GBTI* Resources Library

*eCOA: Getting Better Together Initiative (GBTI), which ran from 2019 to 2024

• Click here to view the closeout Press Release
• Click here to view the final quarterly update (Q4 2024), which includes details of active projects as of December 31, 2024

 

Title	Description	Hover Description	Source	Publication Date	Authors	GBTI	Link
eCOA Lexicon	Description	Without a common lexicon among eCOA vendors, sponsors, and regulators, the chance for miscommunication, errors, and inefficiencies increases. The objective of this team is to review the terminology and create an aligned eCOA Lexicon for use by stakeholders across the eCOA ecosystem.	C-Path	May 2023	GBTI Team	Yes	https://media.c-path.org/wp-content/uploads/20241204203508/GBTI_eCOALexicon_v3.pdf
eCOA: Process, Workflow, Roles, Responsibilities (Abbreviations Table)	Description	Define an eCOA process and workflow that aligns expectations for successful eCOA strategy development and deployment and clarifies roles and responsibilities.	C-Path	December, 2020	GBTI Team	Yes	https://media.c-path.org/wp-content/uploads/20240427173146/GBTI_AbbreviationsTable_v1.pdf
eCOA: Process, Workflow, Roles, Responsibilities(Roles Table)	Description	Define an eCOA process and workflow that aligns expectations for successful eCOA strategy development and deployment and clarifies roles and responsibilities.	C-Path	December, 2020	GBTI Team	Yes	https://media.c-path.org/wp-content/uploads/20240427173146/GBTI_Roles_Table_v1.pdf
eCOA: Process, Workflow, Roles, Responsibilities(Process Step Table)	Description	Define an eCOA process and workflow that aligns expectations for successful eCOA strategy development and deployment and clarifies roles and responsibilities.	C-Path	December, 2020	GBTI Team	Yes	https://media.c-path.org/wp-content/uploads/20240427173145/GBTI_Process_StepTable_v1.0.pdf
eCOA: Process, Workflow, Roles, Responsibilities(Process Workflow)	Description	Define an eCOA process and workflow that aligns expectations for successful eCOA strategy development and deployment and clarifies roles and responsibilities.	C-Path	December, 2020	GBTI Team	Yes	https://media.c-path.org/wp-content/uploads/20240427173144/GBTI_eCOA_Process_Workflow_v1.pdf
Best Practice Recommendations: User Acceptance Testing for Systems Designed to Collect Clinical Outcome Assessment Data Electronically	Article	This article provides best practice recommendations for user acceptance testing to support a high-quality eCOA system and ensure reliable and more complete data are collected during the study.	Therapeutic Innovation & Regulatory Science	March 1, 2022	Gordon S, Crager J, Howry C, Barsdorf AI, Cohen J, Crescioni M, Dahya B, Delong P, Knaus C, Reasner DS, Vallow S, Zarzar K, Eremenco S	Yes	https://link.springer.com/article/10.1007/s43441-021-00363-z
Best Practice Recommendations for Electronic Patient-Reported Outcome (ePRO) Dataset Structure and Standardization to Support Drug Development	Article	This article discusses best practice recommendations covering the application of CDISC standards for ePRO Datasets, the involvement of key stakeholders, and strategies to manage ePRO dataset content, quality control, and validation.	Value in Health	August 2023	Hudgens S, Kern S, Barsdorf AI, Cassells S, Rowe A, King-Kallimanis BL, Coon C, Low G, Eremenco S	Yes	https://www.valueinhealthjournal.com/article/S1098-3015(23)00060-8/fulltext?_returnURL=https://linkinghub.elsevier.com/retrieve/pii/S1098301523000608?showall=true
Best Practice Recommendations for Electronic Clinical Outcome Assessment Data Changes	Article	This article presents key best practices that are aligned to the latest health authority guidance. From 2018 to 2022, 45 representatives of C-Path’s Patient-Reported Outcome Consortium, eCOA Consortium, and the eClinical Forum collaborated to develop guidelines on changes to eCOA data. The resulting core principles can become the foundation upon which sponsors, investigators, and eCOA providers can evaluate and manage data change requests.	Journal of the Society for Clinical Data Management	December 14, 2023	Delong P, Humler D, Haag T, Yeomans A, Andrus J, Eremenco S, Finan A, Gable J, Gilfillan D, Howry C, Kern S, Lesniewski S, Simpliciano K, Staunton H, Turnbull J, Workman C, Raymond S	Yes	https://www.jscdm.org/article/id/249/
Best Practice Recommendations for Electronic Clinical Outcome Assessment Data Changes	Webinar	This webinar provides key best practices of electronic clinical outcome assessment data changes that are aligned to the latest health authority guidance. It is based on the article published on December 14, 2023, in the Journal of the Society for Clinical Data Management.	C-Path	February 6, 2024	Delong P, Humler D, Yeomans A	Yes	https://youtu.be/5PX6sfXPg8U
Best Practice Recommendations for Electronic Clinical Outcome Assessment Data Changes	Post-Webinar Q&A	Provides answers to questions that were received during the Q&A portion of the webinar but not answered due to time limitations. The webinar provided best practices of electronic clinical outcome assessment data changes that are aligned to the latest health authority guidance. It is based on the article published on December 14, 2023, in the Journal of the Society for Clinical Data Management.	C-Path	February 6, 2024	GBTI Team	Yes	https://media.c-path.org/wp-content/uploads/20240510123257/eCOADataChanges-PostWebinarQA.pdf
Best Practice Recommendations for Electronic Clinical Outcome Assessment Data Changes	Slides	The slide deck presented during the webinar on February 6, 2024. The webinar provided best practices of electronic clinical outcome assessment data changes that are aligned to the latest health authority guidance. It is based on the article published on December 14, 2023, in the Journal of the Society for Clinical Data Management.	C-Path	February 6, 2024	GBTI Team	Yes	https://media.c-path.org/wp-content/uploads/20240427170529/eCOADataChanges_FINAL-2.pdf
Flexible approaches to eCOA administration in clinical trials: The site perspective	Article	This article presents the results of a survey of eCOA-experienced clinical trial sites to understand their challenges and gather suggestions for simplification that may result in a more flexible, participant- and site-centric approach to ePRO implementation in clinical trials.	Contemporary Clinical Trials Communications	December 7, 2023	Haenel E, Elash C, Garner K, Turner M, Kern S on behalf of the Electronic Clinical Outcome (eCOA) Consortium and the Patient-Reported Outcome (PRO) Consortium	Yes	https://www.sciencedirect.com/science/article/pii/S2451865423001874?via=ihub
Bring Your Own Device (BYOD)	Podcast	This podcast provides an exploration of the conceptual challenges around BYOD adoption.	C-Path	April, 2022	Steele S, Kern S	Yes	https://www.youtube.com/watch?v=OHu6XbKTo9o
Bring Your Own Device (BYOD)	Webinar	This webinar highlights the key recommendations to enable successful BYOD implementation.	C-Path	July 18, 2024	Dumais K, McEvoy K, Romero H, Barden C	Yes	https://www.youtube.com/watch?v=DILxBKJSJvI
Bring Your Own Device (BYOD)	Guide Slides	These guide slides provide a more detailed version of the webinar slides with more granular recommendations.	C-Path	July 18, 2024	GBTI Team	Yes	https://media.c-path.org/wp-content/uploads/20240726132856/GBTI-BYOD-Webinar-GuideSlides.pdf
Conflicting Terminology in Digital Health Space: A Call for Consensus			Applied Clinical Trials	February 15, 2023	eCOA Consortium	No	https://www.appliedclinicaltrialsonline.com/view/conflicting-terminology-in-digital-health-space-a-call-for-consensus
First-hand Perspectives on Achieving True Digital Health Engagement			Applied Clinical Trials	December 2, 2022	eCOA Consortium	No	https://www.appliedclinicaltrialsonline.com/view/first-hand-perspectives-on-achieving-true-digital-health-engagement
Comparability of a provisioned device versus bring your own device for completion of patient-reported outcome measures by participants with chronic obstructive pulmonary disease: quantitative study findings			Journal of Patient-Reported Outcomes	November 26, 2022	Stacie Hudgens, Louise Newton, Sonya Eremenco, Mabel Crescioni, Tara Symonds, Philip C. G. Griffiths, David S. Reasner, Bill Byrom, Paul O’Donohoe, Susan Vallow on behalf of the Patient-Reported Outcome (PRO) Consortium and Electronic Clinical Outcome Assessment (eCOA) Consortium	No	https://jpro.springeropen.com/articles/10.1186/s41687-022-00521-3
Implementing Numeric Rating and Visual Analog Scales in an eCOA Solution			Applied Clinical Trials	November 10, 2022	eCOA Consortium	No	https://www.appliedclinicaltrialsonline.com/view/implementing-numeric-rating-and-visual-analog-scales-in-an-ecoa-solution
Survey Investigates Backup Solution Adoption for ePRO Systems			Applied Clinical Trials	October 14, 2022	eCOA Consortium	No	https://www.appliedclinicaltrialsonline.com/view/survey-investigates-backup-solution-adoption-for-epro-systems
Evaluating the Use of Backup Solutions for ePRO Systems			Applied Clinical Trials	September 7, 2022	eCOA Consortium	No	https://www.appliedclinicaltrialsonline.com/view/evaluating-the-use-of-backup-solutions-for-epro-systems
Measurement Comparability of Electronic and Paper Administration of Visual Analogue Scales: A Review of Published Studies			Therapeutic Innovation & Regulatory Science	February 10, 2022	Byrom B, Elash CA, Eremenco S, Bodart S, Muehlhausen W, Platko JV, Watson C, Howry C	No	https://doi.org/10.1007/s43441-022-00376-2
Comparability of a Provisioned Device Versus Bring Your Own Device for Completion of Patient-Reported Outcome Measures by Participants with Chronic Obstructive Pulmonary Disease: Qualitative Interview Findings			Journal of Patient-Reported Outcomes	April 4, 2022	Newton L, Knight-West O, Eremenco S, Hudgens S, Crescioni M, Symonds T, Reasner DS, Byrom B, O’Donohoe P, Vallow S on behalf of the Patient-Reported Outcome Consortium and the Electronic Clinical Outcome Assessment Consortium	No	https://doi.org/10.1186/s41687-022-00492-5
Progressing BYOD Adoption			Applied Clinical Trials	June 4, 2022	eCOA Consortium	No	https://www.appliedclinicaltrialsonline.com/view/progressing-byod-adoption
Administering Complex Cognitive Tests Remotely in The Cognitively-Impaired			Applied Clinical Trials	June 7, 2022	eCOA Consortium	No	https://www.appliedclinicaltrialsonline.com/view/administering-complex-cognitive-tests-remotely-in-the-cognitively-impaired
The Power of Collaboration: Introducing the eCOA Consortium			Applied Clinical Trials	May 12, 2022	eCOA Consortium	No	https://www.appliedclinicaltrialsonline.com/view/the-power-of-collaboration-introducing-the-ecoa-consortium
Best Practice Recommendations: User Acceptance Testing for Systems Designed to Collect Clinical Outcome Assessment Data Electronically			Therapeutic Innovation & Regulatory Science	March 1, 2022	Gordon S, Crager J, Howry C, Barsdorf AI, Cohen J, Crescioni M, Dahya B, Delong P, Knaus C, Reasner DS, Vallow S, Zarzar K, Eremenco S	No	https://doi.org/10.1007/s43441-021-00363-z
Recommendations for the Electronic Migration and Implementation of Clinician-reported Outcome Assessments in Clinical Trials			Value in Health	April 1, 2022	Romero H, DeBonis D, O’Donohoe P, Wyrwich K, Arnera V, Platko J, Willgoss T, Harris K, Crescioni M, Steele S, Eremenco S, on behalf of the Electronic Patient-Reported Outcome Consortium and the Patient-Reported Outcome Consortium	No	https://doi.org/10.1016/j.jval.2022.02.012
Demystifying Submissions of eCOA Documentation for Ethics Review: Are We Making Submissions More Difficult than Necessary?			Applied Clinical Trials	August 14, 2020	Gertel A, Raymond S, Vallow S, Arnera V, Crescioni M, Chassany O, Bodart S, Eremenco S	No	https://www.appliedclinicaltrialsonline.com/view/demystifying-submissions-of-ecoa-documentation-for-ethics-review-are-we-making-submissions-more
Agreement Among Paper and Electronic Modes of the EQ-5D-5L			The Patient – Patient-Centered Outcomes Research	April 28, 2020	Lundy JJ, Coons SJ, Flood E, Patel MJ on behalf of the ePRO Consortium	No	https://doi.org/10.1007/s40271-020-00419-6
Perceived Burden of Completion of Patient-Reported Outcome Measures in Clinical Trials: Results of a Preliminary Study			Therapeutic Innovation & Regulatory Science	December 23, 2019	Bodart S, Byrom B, Crescioni M, Eremenco S, Flood E, on behalf of the ePRO Consortium	No	https://doi.org/10.1177%2F2168479018788053
Best Practices for Avoiding Paper Backup When Implementing Electronic Approaches to Patient-Reported Outcome Data Collection in Clinical Trials			Therapeutic Innovation & Regulatory Science	December 23, 2019	Howry C, Elash C, Crescioni M, Eremenco S, O’Donohoe P, Rothrock T, on behalf of the ePRO Consortium	No	https://doi.org/10.1177%2F2168479018785160
Training on the Use of Technology to Collect Patient-Reported Outcome Data Electronically in Clinical Trials: Best Practice Recommendations from the ePRO Consortium			Therapeutic Innovation & Regulatory Science	December 23, 2019	Ly J, Crescioni M, Eremenco S, Bodart S, Donoso M, Butler A, Dallabrida S, on behalf of the ePRO Consortium	No	https://link.springer.com/article/10.1177/2168479018796206
Selection of and Evidententiary Considerations for Wearable Devices and Their Measurements for Use in Regulatory Decision Making: Recommendations from the ePRO Consortium			Value in Health	November 7, 2017	Byrom B, Watson C, Doll H, Coons SJ, Eremenco S, Ballinger R, McCarthy M, Crescioni M, O’Donohoe P, Howry C	No	https://doi.org/10.1016/j.jval.2017.09.012
Optimizing Electronic Capture of Clinical Outcome Assessment Data in Clinical Trials: The Case of Patient-Reported Endpoints			Therapeutic Innovation & Regulatory Science	December 30, 2015	Fleming S, Barsdorf AI, Howry C, O’Gorman H, Coons SJ	No	https://doi.org/10.1177/2168479015609102
“Bring Your Own Device” (BYOD): The Future of Field-Based Patient-Reported Outcome Data Collection in Clinical Trials			Therapeutic Innovation & Regulatory Science	December 30, 2015	Gwaltney C, Coons SJ, O’Donohoe P, O’Gorman H, Denomey M, Howry C, Ross J	No	https://doi.org/10.1177/2168479015609104
Considerations for Requiring Subjects to Provide a Response to Electronic Patient-reported Outcome Instruments			Therapeutic Innovation & Regulatory Science	October 13, 2015	Paul O’Donohoe P, Lundy JJ, Gnanasakthy A, Greene A	No	http://dij.sagepub.com/content/49/6/792.short
Capturing Patient-Reported Outcome (PRO) Data Electronically: The Past, Present, and Promise of ePRO Measurement in Clinical Trials			The Patient – Patient-Centered Outcomes Research	October 10, 2014	Coons SJ, Eremenco S, Lundy JJ, O’Donohoe P, O’Gorman H, Malizia W	No	https://doi.org/10.1007/s40271-014-0090-z
ePRO Systems Validation: Clearly Defining the Roles of Clinical Trials Teams and ePRO System Providers			Value in Health	June, 2013	Coons, SJ	No	https://doi.org/10.1016/j.jval.2013.04.006
Best Practices for Participant Registration in Clinical Trials Using Bring Your Own Device (BYOD) Technology for Data Collection			White Paper	April, 2021	eCOA Consortium	No	https://media.c-path.org/wp-content/uploads/20240427170209/BestPractices5_upd-1.pdf
COVID-19: Risk Assessment and Mitigation Strategies for the Collection of Patient-Reported Outcome Data through Clinical Sites			White Paper	June 5, 2020	eCOA Consortium	No	https://media.c-path.org/wp-content/uploads/20240427170208/COVID-19_CPath_v3.0_2020JUN5-1.pdf
Best Practices for Electronic Implementation of Response Scales for Patient-Reported Outcome Measures			White Paper	September, 2018	eCOA Consortium	No	https://c-path.org/wp-content/uploads/2022/02/BestPractices2_Response_Scales.pdf
Best Practices for Maximizing Electronic Data Capture Options during the Development of New Patient-Reported Outcome Measures			White Paper	September, 2018	eCOA Consortium	No	https://c-path.org/wp-content/uploads/2022/02/BestPractices_Maximizing_Data_Capture.pdf
Best Practices for Migrating Existing Patient-Reported Outcome Measures to a New Data Collection Mode			White Paper	September, 2018	eCOA Consortium	No	https://c-path.org/wp-content/uploads/2022/02/BestPractices3_Migrating.pdf
eCOA Systems and CE Certification			White Paper	March, 2023	eCOA Consortium	No	https://media.c-path.org/wp-content/uploads/20240427170207/eCOA-Systems-and-CE-Certification-1.pdf
eCOA Systems and the CE Mark: Navigating the Regulations			Applied Clinical Trials	March 2, 2023	eCOA Consortium	No	https://www.appliedclinicaltrialsonline.com/view/ecoa-systems-and-the-ce-mark-navigating-the-regulations
Best Practice Recommendations for Electronic Patient-Reported Outcome (ePRO) Dataset Structure and Standardization to Support Drug Development			Value in Health	August, 2023	Hudgens S, Kern S, Barsdorf AI, Cassells S, Rowe A, King-Kallimanis BL, Coon C, Low G, Eremenco S	No	https://doi.org/10.1016/j.jval.2023.02.011
Data Standards and ePRO Systems: A Road Less Travelled?			Applied Clinical Trials	April 14, 2023	eCOA Consortium	No	https://www.appliedclinicaltrialsonline.com/view/data-standards-and-epro-systems-a-road-les-travelled
An eCOA Lexicon: The Quest for Single, Trusted Source of Terminology			Applied Clinical Trials	June 7, 2023	eCOA Consortium	No	https://www.appliedclinicaltrialsonline.com/view/an-ecoa-lexicon-the-quest-for-single-trusted-source-of-terminology
eCOA Systems and Intended Use: Key Considerations			Applied Clinical Trials	September 7, 2023	eCOA Consortium	No	https://www.appliedclinicaltrialsonline.com/view/ecoa-systems-and-intended-use-key-considerations
Training the Raters: An Important Factor in Clinical Trial Success			Applied Clinical Trials	October 13, 2023	eCOA Consortium	No	https://www.appliedclinicaltrialsonline.com/view/training-the-raters-an-important-factor-in-clinical-trial-success
The First eCOA Forum Examines BYOD and Item Skipping			Applied Clinical Trials	August 11, 2023	eCOA Consortium	No	https://www.appliedclinicaltrialsonline.com/view/the-first-ecoa-forum-examines-byod-and-item-skipping
A New and Comprehensive Guide to ePRO Migration and Implementation			Applied Clinical Trials	November 14, 2023	eCOA Consortium	No	https://www.appliedclinicaltrialsonline.com/view/a-new-and-comprehensive-guide-and-epro-migration-and-implementation
Best Practice Recommendations for Electronic Clinical Outcome Assessment Data Changes			Journal of the Society for Clinical Data Management	December 14, 2023	Delong P, Humler D, Haag T, Yeomans A, Andrus J, Eremenco S, Finan A, Gable J, Gilfillan D, Howry C, Kern S, Lesniewski S, Simpliciano K, Staunton H, Turnbull J, Workman C, Raymond S.	No	https://doi.org/10.47912/jscdm.249
Flexible Approaches to eCOA Administration in Clinical Trials: The Site Perspective			Contemporary Clinical Trials Communications	December 7, 2023	Haenel E, Elash C, Garner K, Turner M, Kern S on behalf of the Electronic Clinical Outcome (eCOA) Consortium and the Patient-Reported Outcome (PRO) Consortium	No	https://doi.org/10.1016/j.conctc.2023.101241
Best Practices for the Electronic Implementation and Migration of Patient-Reported Outcome Measures			Value in Health	October 23, 2023	Mowlem F, Elash CA, Dumais KM, Newara MC, Kern S on behalf of the Electronic Clinical Outcome Assessment Consortium	No	https://doi.org/10.1016/j.jval.2023.10.007
Unstructured Patient Diaries: To be, or not to be, that is the Question			Applied Clinical Trials	April 18, 2024	eCOA Consortium	No	https://www.appliedclinicaltrialsonline.com/view/unstructured-patient-diaries-to-be-or-not-to-be-that-is-the-question
Implementing Sensor-based Digital Health Technologies in Clinical Trials: key Considerations from the eCOA Consortium			Clinical and Translational Science	November 3, 2024	eCOA Consortium	No	http://dx.doi.org/10.1111/cts.70054

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