Supplementary Material for: Why Language Matters in Digital Endpoint Development: harmonized terminology as a key pre-requisite for evidence generation

Developments in the field of digital measures and endpoints derived from digital health technologies (DHTs) demand greater attention on harmonized approaches to enhance acceptance by regulatory authorities and health technology assessment bodies for decision making. As in any nascent field, greater alignment of concepts, definitions and terminology is required. This is a fast-moving complex area, every day brings new technologies, algorithms, and possibilities. A common language is particularly important when working in multifunctional teams and stakeholders to ensure that there is a clear understanding of what is meant and understood.

In the paper the EFPIA digital endpoint subgroup review the challenges facing teams working to advance digital endpoints: different terms used to describe the same things, common terms such as “monitoring” have significantly different meaning under different regulatory frameworks, the preface “e” denoting electronic and “digital” are used in different contexts and significant confusion as to what is understood by “raw” when it comes to data derived from DHTs.

The EFPIA subgroup is calling for an aligned lexicon across stakeholders and regulatory agencies such as FDA and EMA. The paper builds on established glossaries for the concepts of biomarkers, clinical outcome assessment and endpoints (e.g., BEST glossary). We propose where alignment is required and initiates discussion on those terms that are not established yet are important. Alignment provides a more predictable path for development, validation, and use of DHT-derived endpoints supporting standardization and consistency, with the goal of increasing regulatory and payer harmonization and acceptance.