Evaluation, acceptance, and qualification of digital measures: From proof of concept to endpoint
ABSTRACT: To support the successful adoption of digital measures into internal decision making and evidence generation for medical product development, we present a unified lexicon to aid communication throughout this process, and highlight key concepts including the critical role of participant engagement in development of digital measures. We detail the steps of bringing a successful proof of concept to scale, focusing on key decisions in the development of a new digital measure: asking the right question, optimized approaches to evaluating new measures, and whether and how to pursue qualification or acceptance. Building on the V3 framework for establishing verification and analytical and clinical validation, we discuss strategic and practical considerations for collecting this evidence, illustrated with concrete examples of trailblazing digital measures in the field.
Evaluation, acceptance, and qualification of digital measures: From proof of concept to endpoint
ABSTRACT: To support the successful adoption of digital measures into internal decision making and evidence generation for medical product development, we present a unified lexicon to aid communication throughout this process, and highlight key concepts including the critical role of participant engagement in development of digital measures. We detail the steps of bringing a successful proof of concept to scale, focusing on key decisions in the development of a new digital measure: asking the right question, optimized approaches to evaluating new measures, and whether and how to pursue qualification or acceptance. Building on the V3 framework for establishing verification and analytical and clinical validation, we discuss strategic and practical considerations for collecting this evidence, illustrated with concrete examples of trailblazing digital measures in the field.
Evaluation, acceptance, and qualification of digital measures: From proof of concept to endpoint
Goldsack J.C, Dowling A.V, Samuelson D, Patrick-Lake B, and Clay I
ABSTRACT: To support the successful adoption of digital measures into internal decision making and evidence generation for medical product development, we present a unified lexicon to aid communication throughout this process, and highlight key concepts including the critical role of participant engagement in development of digital measures. We detail the steps of bringing a successful proof of concept to scale, focusing on key decisions in the development of a new digital measure: asking the right question, optimized approaches to evaluating new measures, and whether and how to pursue qualification or acceptance. Building on the V3 framework for establishing verification and analytical and clinical validation, we discuss strategic and practical considerations for collecting this evidence, illustrated with concrete examples of trailblazing digital measures in the field.
Evaluation, acceptance, and qualification of digital measures: From proof of concept to endpoint
Evidation and the Duke Big Ideas Lab have announced a partnership that aims to find ways to both increase representation of underserved populations and improve adherence among all participants in digital health studies.
The organizations are working together to build an analytic structure that will be available to other digital health researchers, helping to better predict study participation, adherence, and retention. Click below to read more about the project, led by Iredia M. Olaye, PhD, MSc, MHA, of Covered By Group and Evidation, in HealthLeaders.
Thanks to everyone who took the time to meet with us in San Francisco at this year’s J.P. Morgan Annual Conference and its surrounding events. Our team looks forward to staying in touch and helping you produce better health outcomes in 2023!
Get to know your Evidation team
Bertina Yen, Evidation's Senior Vice President of People & Community
Bertina Yen is Evidation's Senior Vice President of People & Community, where she is responsible for the end-to-end employee experience and building a community that supports everyone's ability to show up as their authentic selves and perform their best work. Prior to joining Evidation, Bertina served as EVP overseeing clinical teams, product management, marketing, and product development at Zynx Health, driving development of evidence-based clinical decision support solutions that improve health and financial outcomes.
Bertina received her BAS from Stanford, then completed her MD and residency in internal medicine at UC San Diego. She also holds an MPH in health services administration from UCLA.
Bertina is the resident DJ at Evidation and sources the music that is played during the All-Employee Meetings. Outside of work, she enjoys hiking, traveling, and watching anything with a live audience (sporting events, plays, movies). She also starts every morning by completing at least one crossword puzzle!
Evaluation, acceptance, and qualification of digital measures: From proof of concept to endpoint
ABSTRACT: To support the successful adoption of digital measures into internal decision making and evidence generation for medical product development, we present a unified lexicon to aid communication throughout this process, and highlight key concepts including the critical role of participant engagement in development of digital measures. We detail the steps of bringing a successful proof of concept to scale, focusing on key decisions in the development of a new digital measure: asking the right question, optimized approaches to evaluating new measures, and whether and how to pursue qualification or acceptance. Building on the V3 framework for establishing verification and analytical and clinical validation, we discuss strategic and practical considerations for collecting this evidence, illustrated with concrete examples of trailblazing digital measures in the field.
ABSTRACT: To support the successful adoption of digital measures into internal decision making and evidence generation for medical product development, we present a unified lexicon to aid communication throughout this process, and highlight key concepts including the critical role of participant engagement in development of digital measures. We detail the steps of bringing a successful proof of concept to scale, focusing on key decisions in the development of a new digital measure: asking the right question, optimized approaches to evaluating new measures, and whether and how to pursue qualification or acceptance. Building on the V3 framework for establishing verification and analytical and clinical validation, we discuss strategic and practical considerations for collecting this evidence, illustrated with concrete examples of trailblazing digital measures in the field.
