Electronic Clinical Outcome Assessment Consortium

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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
  • 14 webinars
  • 16 peer-reviewed publications
  • 10 poster presentations
  • 17 podium presentations

More information about these resources can be found here.

Resources

eCOA Consortium Publications/White Papers Library FAQ Icon

eCOA Consortium Publications/White Papers Library

eCOA: Getting Better Together Initiative FAQ Icon

eCOA: Getting Better Together Initiative This initiative is a pre-competitive collaboration among Critical Path Institute, clinical trial sponsors from the Patient-Reported Outcome (PRO) Consortium, providers of electronic data collection technologies and services from the Electronic Clinical Outcome Assessment (eCOA) Consortium, contract research organizations, and regulators. The initiative was launched in 2019 to identify and address the root cause of challenges with the implementation of clinical outcome assessments collected electronically in clinical trials, elevate eCOA improvement efforts to the clinical trial industry level, and drive positive and lasting change in the eCOA ecosystem.

Quarterly Update

Please click here to view the most recent quarterly update, which includes the status of current and future areas of focus.

eCOA: Getting Better Together Initiative

Resources

Name Description Links
eCOA Lexicon 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. eCOA Lexicon
eCOA: Process/Workflow and Roles/Responsibilities Define an eCOA process and workflow that aligns expectations for successful eCOA strategy development and deployment and clarifies roles and responsibilities. Abbreviations Table

Roles Table

Process Step Table

Process Workflow

Best Practice Recommendations: User Acceptance Testing for Systems Designed to Collect Clinical Outcome Assessment Data Electronically 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
Best Practice Recommendations for Electronic Patient-Reported Outcome (ePRO) Dataset Structure and Standardization to Support Drug Development This article discusses best practice recommendations covering the application of CDISC standards for ePRO Datasets, involvement of key stakeholders, and strategies to manage ePRO dataset content, quality control, and validation. Value in Health
Best Practice Recommendations for Electronic Clinical Outcome Assessment Data Changes 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. Best Practice Recommendations for Electronic Clinical Outcome Assessment Data Changes

Webinar

Flexible approaches to eCOA administration in clinical trials: The site perspective This article presents 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
Bring Your Own Device (BYOD) This podcast discusses the use of BYOD approaches for the collection of eCOA data in clinical trials. The podcast offers a review of lessons learned from a year-long initiative that is investigating both what is needed to implement BYOD approaches as well as what can be done to accelerate the adoption of BYOD approaches in clinical trials. Bring Your Own Device (BYOD)

Webinars

Best Practice Recommendations for Electronic Clinical Outcome Assessment Data Changes (February 6, 2024) FAQ Icon

This webinar presents an overview of the published article in the Journal of the Society for Clinical Data Management that provides key best practices of electronic clinical outcome assessment data changes that are aligned to the latest health authority guidance.  From 2018 to 2022, 45 representatives of Critical Path (C-Path) Institute’s Patient-Reported Outcome (PRO) 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 (DCRs).

Moderator: Scottie Kern (C-Path)

Presenters:

  • Trish Shepherd Delong (J&J Innovative Medicine)
  • Demian Humler (Clario)
  • Alan Yeomans (Viedoc)

View the recording here.

eCOA Clinic #1: BYOD (Bring Your Own Device) (December 12, 2023) FAQ Icon

This 1st eCOA Clinic — the third installment of our eCOA Educational Series — offered attendees the chance to bring their own questions on the topic of BYOD to be addressed by experts from across the eCOA Consortium’s membership, with matters ranging from the impact of BYOD on study timelines to the regulatory perspective on BYOD.
[cpns_locked_video src=”https://c-path.org/wp-content/uploads/2024/01/eCOA-Clinic-1_-BYOD-Bring-Your-Own-Device.mp4″ password=”xi54nddkcd67sd” referer=”eCOA webinars” width=”700″ height=”394″ form-text=”To access the eCOA Educational Series, please provide your email address”]

Moderator: Scottie Kern (C-Path)

Presenters: Chris Barden (Kayentis), Lisa Charlton (Science 37), Kelly Dumais (Clario), Karl McEvoy (YPrime), and Flo Mowlem (ObvioHealth)

eCOA Exchange #2: What is (and What is Not) an Appropriate Wearable Device for Use in Clinical Trials? (Oct. 19, 2023) FAQ Icon

This eCOA Exchange — the second in our eCOA Educational Series — identifies and examines the key considerations around the selection and implementation of sensor-based wearable technologies in clinical trials. An expert panel with deep experience in the field and formed from our eCOA Consortium members ActiGraph, Koneksa, Parexel, and uMotif share their perspectives on how successful use of these powerful tools can be achieved.

Moderator: Scottie Kern (C-Path)

Presenters: Julia Kling (Koneksa), Julia Lakeland (uMotif), Ian Pallett (Parexel), Sylvain Zorman (ActiGraph)

eCOA Exchange #1: How to Succeed with Global eCOA Implementations (September 27, 2023) FAQ Icon

This eCOA Exchange session examines what clinical operations teams should be prepared for, from an eCOA translations and licensing perspective, when running multi-country trials. Translations and licensing experts from eCOA Consortium members Mapi Research Trust, RWS, and TransPerfect Life Sciences share key considerations and experience-based recommendations to reduce the risk to study start-up for global eCOA trials.

Moderator: Scottie Kern (C-Path)

Presenters: Elsa Lindstrom (TransPerfect Life Sciences), Shawn McKown (RWS), and Foteini Sakellaropoulou (Mapi Research Trust)

PDF Version

eCOA: Getting Better Together Initiative – An Update from C-Path’s PRO Consortium and ePRO Consortium (February 17, 2021) FAQ Icon

This webinar provides an overview of the eCOA: Getting Better Together Initiative. This collaborative, pre-competitive initiative was launched in 2019 to identify and address the root cause of issues with eCOA implementation in clinical trials and to drive positive and lasting change in the eCOA ecosystem for the benefit of all stakeholders. This webinar discusses the achievements and future goals of the initiative, in addition to recent highlights from each consortium.

Moderator: Keith Wenzel (Parexel)

Presenters: Sonya Eremenco, MA (C-Path) and Paul O’Donohoe, MSc (Medidata Solutions)

PDF Version

COVID-19: Risk Assessment and Mitigation Strategies for the Collection of PRO Data through Clinical Sites – Lessons Learned (October 29, 2020) FAQ Icon

This webinar provides an update from sponsors and eCOA providers as they discuss lessons learned from managing clinical trials that originally planned for in-person collection of ePRO data through clinical sites. Due to public health concerns, many patients are either unable or unwilling to travel to sites for scheduled visits or sites have had to close. In March 2020, ePRO Consortium and PRO Consortium member representatives collaborated on risk assessment and mitigation strategies for clinical trials in response to COVID-19. This webinar discusses lessons learned, how the initial recommendations performed, and how sponsors and eCOA providers are applying these learnings to future trials.

Moderator: Sonya Eremenco, MA (C-Path)

Presenters: Patricia (Trish) Delong, MS (Janssen Global Services, LLC); Gena Gough, MBA, PMP (Clinical Ink); Cindy Howry, MS (.assisTek); Paul O’Donohoe, MSc (Medidata Solutions); and, Megan Turner (GlaxoSmithKline)

PDF Version

Demystifying Submissions of eCOA Documentation for Ethics Review: Are We Making Submissions More Difficult Than Necessary? (September 18, 2019) FAQ Icon

This webinar presents an overview of Good Clinical Practice (GCP)/ethics review guidelines (ICH E6 R2), which indicate that written information provided to the patient must be submitted for ethical review. Many have broadly interpreted the GCP requirement concerning “written information” to mean that screenshots for every proposed patient-facing image must be provided for review, approval, and filing prior to study information. The presenters question whether requests from ethics review bodies for eCOA screenshots is warranted and will propose a new path forward.

Presenters: Steve Raymond, PhD (ERT); Art Gertel (MedSciCom, LLC); Olivier Chassany, MD, PhD (Paris-Diderot University and INSERM); and, David Forster, JD, MA, CIP (WIRB-Copernicus Group)

PDF Version

Note: Audio is not available for this webinar.

Best Practices for Avoiding Paper Backup When Implementing Electronic Approaches to Patient-Reported Outcome Data Collection in Clinical Trials (May 16, 2019) FAQ Icon

This webinar provides an overview of the issues related to the use of paper backups in studies for which PRO data is collected electronically. Viable strategies to eliminate the necessity of a paper-backup system are provided.

Presenters: Cindy Howry, MS (.assisTek) and Paul O’Donohoe, MSc (Medidata Solutions)

PDF Version

Training on the Use of Technology to Collect Patient-Reported Outcome Data Electronically in Clinical Trials: Best Practice Recommendations from the ePRO Consortium (May 10, 2018) FAQ Icon

This webinar provides a recommended framework for training end users, including site staff and study participants, on the use of ePRO technology in clinical trials. The goal of the webinar is to promote consistent and sufficient training prior to initiating data collection.

Presenters: Jenny J. Ly, PhD (ERT) and Serge Bodart, MSc (Bracket)

PDF Version

 

Selection of and Evidentiary Considerations for Wearable Devices and their Measurements for Use in Regulatory Decision Making: Recommendations from the ePRO Consortium (May 18, 2017) FAQ Icon

This webinar provides a recommended framework for the selection and evaluation of wearable devices and their measurements for use in regulatory trials to support labeling claims. The webinar will also address the essential properties of fit-for-purpose wearables and the activities required to establish clinical endpoints derived from data collected with wearable devices.

Presenters: Bill Byrom, PhD (ICON) and Chris Watson, PhD (ERT)

PDF Version

Considerations for Requiring Subjects to Respond to PRO Instruments Collected Electronically (February 28, 2017) FAQ Icon

This webinar provides an overview of specific considerations related to allowing subjects to opt out of responding to individual items when PRO data collection is electronic as well as the relevance to other types of electronic clinical outcome assessments.

Presenter: Paul O’Donohoe, MS (CRF Health)

PDF Version

Ensuring Equivalence of Electronic and Paper Administration of Patient-Reported Outcome Measures (September 29, 2016) FAQ Icon

This webinar provides an overview of scientific and regulatory considerations when migrating paper-based patient-reported outcome (PRO) measures to electronic modes of data collection.

Presenters: Paul O’Donohoe, MS (CRF Health) and Willie Muehlhausen, DVM (ICON)

PDF Version

Bring Your Own Device (BYOD) (March 10, 2016) FAQ Icon

This webinar provides an overview of scientific, logistical, and regulatory considerations when using a BYOD approach to collect patient-reported outcome data in clinical trials.

Presenters: Jennifer Crager (YPrime) and Paul O’Donohoe, MS (CRF Health)

PDF Version

Best Practices for ePRO Implementation in Clinical Trials (December 3, 2015) FAQ Icon

This webinar provides an overview of considerations in selecting the optimal ePRO modes, review best practices related to the deployment of ePRO systems, and discuss key items for ePRO deployment in clinical trials.

Presenters: Serge Bodart, MS (Biomedical Systems) and Elisa Holzbaur, BS, PMP (Almac)

PDF Version

Migrating a PRO Instrument (May 6, 2015) FAQ Icon

This webinar provides a detailed description of the process for conducting paper to ePRO migration, mode-specific migrations, usability, feasibility and user acceptance testing as well as case studies of successful migrations.

Presenters: Serge Bodart, MSc (Biomedical Systems) Alisandra Johnson, BS (Bracket)

PDF Version

Intro to ePRO – Part II (April 13, 2015) FAQ Icon

This webinar provides an overview of current ePRO data collection modes, the mode selection process, key considerations for selecting the most appropriate mode for a study and considerations for migrating an existing PRO instrument to an electronic mode.

Presenters: Cindy Howry, MS (YPrime) and Jennifer Ross, MPhilEd (Almac)

PDF Version

Intro to ePRO – Part I (January 12, 2015) FAQ Icon

This webinar provides an overview of the ePRO Consortium, describes the various modes of PRO data capture, and discusses the trends in the collection of clinical data electronically.

Presenters: J. Jason Lundy, PhD (C-Path) and Valdo Arnera, MD (PHT Corp)

PDF Version

Team

C-Path Personnel

Scottie Kern,
Executive Director, eCOA Consortium

Cheryl D. Coon, PhD,
Vice President, Clinical Outcome Assessment (COA) Program

Christian Noll, MBA, PMP,
Associate Director, eCOA Consortium

Janelle Russell,
Senior Project Coordinator

Theresa “T” Griffey, MBA, PMP,
Associate Director, Clinical Outcome Assessment (COA) Program

Florence Mowlem, PhD,
Vice President, Science, ObvioHealth Industry Co-Director

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