Lessons learned in the Apple Heart Study and implications for the data management of future digital clinical trials. Issue 3 (4th May 2022)

• Record Type: Journal Article
• Authors: Garcia, Ariadna; Balasubramanian, Vidhya; Lee, Justin; Gardner, Rebecca; Gummidipundi, Santosh; Hung, Grace; Ferris, Todd; Cheung, Lauren; Granger, Christopher; Kowey, Peter; Rumsfeld, John; Russo, Andrea; Hills, Mellianie Ture; Talati, Nisha; Nag, Divya; Stein, Jeffrey; Tsay, David; Desai, Sumbul; Mahaffey, Kenneth; Turakhia, Mintu; Perez, Marco; Hedlin, Haley; Desai, Manisha
• Is Part Of: Journal of biopharmaceutical statistics. Volume 32:Issue 3(2022)
• Page Start: 496
• Page End: 510
• Publication Date: 2022-05-04
• Subjects: Atrial fibrillation -- digital clinical trial -- digital health -- pragmatic trial -- wearables; Pharmacy -- Statistical methods -- Periodicals; Drugs -- Testing -- Statistical methods -- Periodicals; Biometry -- Periodicals; Biopharmaceutics -- Periodicals; Pharmacokinetics -- Periodicals; 615.19
• DOI: 10.1080/10543406.2022.2080698
• Languages: English
• ISSNs: 1054-3406

Abstract

ABSTRACT: The digital clinical trial is fast emerging as a pragmatic trial that can improve a trial's design including recruitment and retention, data collection and analytics. To that end, digital platforms such as electronic health records or wearable technologies that enable passive data collection can be leveraged, alleviating burden from the participant and study coordinator. However, there are challenges. For example, many of these data sources not originally intended for research may be noisier than traditionally obtained measures. Further, the secure flow of passively collected data and their integration for analysis is non-trivial. The Apple Heart Study was a prospective, single-arm, site-less digital trial designed to evaluate the ability of an app to detect atrial fibrillation. The study was designed with pragmatic features, such as an app for enrollment, a wearable device (the Apple Watch) for data collection, and electronic surveys for participant-reported outcomes that enabled a high volume of patient enrollment and accompanying data. These elements led to challenges including identifying the number of unique participants, maintaining participant-level linkage of multiple complex data streams, and participant adherence and engagement. Novel solutions were derived that inform future designs with an emphasis on data management. We build upon the excellent framework of the Clinical Trials Transformation Initiative to provide a comprehensive set of guidelines for data management of the digital clinical trial that include an increased role of collaborative data scientists in the design and conduct of the modern digital trial.