An aligned framework of actively collected and passively monitored clinical outcome assessments (COAs) for measure selection

Christine Manta Campbell; Courtney Webster; Megan Parisi; Roya Sherafat-Kazemzadeh; Jessica Braid; Thomas Switzer; Marcelo Alves Fávaro; Caprice Sassano; Andrea Coravos

doi:10.1038/s41746-024-01068-x

An aligned framework of actively collected and passively monitored clinical outcome assessments (COAs) for measure selection

NPJ Digit Med. 2024 Mar 16;7(1):71. doi: 10.1038/s41746-024-01068-x.

Authors

Affiliations

¹ HumanFirst Inc., San Francisco, CA, USA. [email protected].
² HumanFirst Inc., San Francisco, CA, USA.
³ Nymbly LLC, Seattle, WA, USA.
⁴ Syneos Health®, Morrisville, NC, USA.
⁵ Mapi Research Trust, Lyon, France.
⁶ Roche Products Ltd., Welwyn Garden City, UK.
⁷ Genentech, Inc., South San Francisco, CA, USA.
⁸ Harvard-MIT Center for Regulatory Science, Boston, MA, USA.

Abstract

Regulators increasingly require clinical outcome assessment (COA) data for approval. COAs can be collected via questionnaires or digital health technologies (DHTs), yet no single resource provides a side-by-side comparison of tools that collect complementary or related COA measures. We propose how to align ontologies for actively collected and passively monitored COAs into a single framework to allow for rapid, evidence-based, and fit-for-purpose measure selection.