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Lessons learned in the Apple Heart Study and implications for the data management of future digital clinical trials.

Publication ,  Journal Article
Garcia, A; Balasubramanian, V; Lee, J; Gardner, R; Gummidipundi, S; Hung, G; Ferris, T; Cheung, L; Granger, C; Kowey, P; Rumsfeld, J; Russo, A ...
Published in: J Biopharm Stat
May 4, 2022

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.

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Published In

J Biopharm Stat

DOI

EISSN

1520-5711

Publication Date

May 4, 2022

Volume

32

Issue

3

Start / End Page

496 / 510

Location

England

Related Subject Headings

  • Wearable Electronic Devices
  • Surveys and Questionnaires
  • Statistics & Probability
  • Prospective Studies
  • Humans
  • Data Management
  • 4905 Statistics
  • 3214 Pharmacology and pharmaceutical sciences
  • 1115 Pharmacology and Pharmaceutical Sciences
 

Citation

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Garcia, A., Balasubramanian, V., Lee, J., Gardner, R., Gummidipundi, S., Hung, G., … Desai, M. (2022). Lessons learned in the Apple Heart Study and implications for the data management of future digital clinical trials. J Biopharm Stat, 32(3), 496–510. https://doi.org/10.1080/10543406.2022.2080698
Garcia, Ariadna, Vidhya Balasubramanian, Justin Lee, Rebecca Gardner, Santosh Gummidipundi, Grace Hung, Todd Ferris, et al. “Lessons learned in the Apple Heart Study and implications for the data management of future digital clinical trials.J Biopharm Stat 32, no. 3 (May 4, 2022): 496–510. https://doi.org/10.1080/10543406.2022.2080698.
Garcia A, Balasubramanian V, Lee J, Gardner R, Gummidipundi S, Hung G, et al. Lessons learned in the Apple Heart Study and implications for the data management of future digital clinical trials. J Biopharm Stat. 2022 May 4;32(3):496–510.
Garcia, Ariadna, et al. “Lessons learned in the Apple Heart Study and implications for the data management of future digital clinical trials.J Biopharm Stat, vol. 32, no. 3, May 2022, pp. 496–510. Pubmed, doi:10.1080/10543406.2022.2080698.
Garcia A, Balasubramanian V, Lee J, Gardner R, Gummidipundi S, Hung G, Ferris T, Cheung L, Granger C, Kowey P, Rumsfeld J, Russo A, Hills MT, Talati N, Nag D, Stein J, Tsay D, Desai S, Mahaffey K, Turakhia M, Perez M, Hedlin H, Desai M. Lessons learned in the Apple Heart Study and implications for the data management of future digital clinical trials. J Biopharm Stat. 2022 May 4;32(3):496–510.

Published In

J Biopharm Stat

DOI

EISSN

1520-5711

Publication Date

May 4, 2022

Volume

32

Issue

3

Start / End Page

496 / 510

Location

England

Related Subject Headings

  • Wearable Electronic Devices
  • Surveys and Questionnaires
  • Statistics & Probability
  • Prospective Studies
  • Humans
  • Data Management
  • 4905 Statistics
  • 3214 Pharmacology and pharmaceutical sciences
  • 1115 Pharmacology and Pharmaceutical Sciences