Founded in 2011, the Electronic Clinical Outcome Assessment (eCOA) Consortium provides scientific leadership and best practice recommendations surrounding electronic data capture technologies and services that support the collection of patient-focused outcomes data in clinical trials.

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.