OBJECTIVES: The use of Digital Health Technologies (DHT) in drug development studies is maturing. Taking into account the qualification of digital endpoints (DE) by the EMA and the inclusion of DHT passive Clinical Outcome Assessment’s (COA) in the FDA Drug Development Tool Qualification program. We review the use of DHT to generate endpoint data in drug development studies and support labelling claims.

METHODS: ClinicalTrials.gov was mined using the following search criteria; Completed, Interventional, Industry, Phase 3 and 4 studies (no time limit). Study outcomes were searched using 64 predefined key terms; including device names (e.g. Actigraph), generic terms (e.g. Digital), and Technology (e.g. Accelerometer). Drugs and biologicals studies were reviewed to ensure DHT generated endpoint data. Labels and medical reviews (MR) of identified drugs were examined. A review of FDA and EMA COA Qualification Programs was undertaken in June 2021.

RESULTS: 125 phase 3/4 studies and 111 drugs’ were identified. 4 drugs (2 EMA, 2 FDA) mentioned DHT in both their labels and MR. 2 labels used terms that reflect the use of DHT’s “exercise” and “Steps” without the specific mention of the DHT used. 10 drugs referred to DHT in MR only (7 EMA, 3 FDA).

The EMA have qualified 3 DE and issued 3 letters of support. The FDA have received 8 letters of Intent for DHT passive COA. 2 studies used EMA qualified endpoints (Stride velocity 95^th percentile in Duchenne Muscular Dystrophy and Proactive in Chronic obstructive pulmonary disease).

CONCLUSIONS: Data generated from DHT and qualified DE are being used as primary and secondary endpoints in phase 3 drug studies. This data is reflected in labelling text even if the DHT is not always overt. While the numbers are still small we anticipate that as the regularity qualification programs approve more DE, this number will mature.