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. 2020 Apr 3:3:50.
doi: 10.1038/s41746-020-0259-x. eCollection 2020.

Quantifying the use of connected digital products in clinical research

Caroline Marra  1 , Jacqueline L Chen  1 , Andrea Coravos  2   3   4 , Ariel D Stern  1   2
Affiliations

Quantifying the use of connected digital products in clinical research

Caroline Marra et al. NPJ Digit Med. .

Abstract

Over recent years, the adoption of connected technologies has grown dramatically, with potential for improving health care delivery, research, and patient experience. Yet, little has been documented about the prevalence and use of connected digital products (e.g., products that capture physiological and behavioral metrics) in formal clinical research. Using 18 years of data from ClinicalTrials.gov, we document substantial growth in the use of connected digital products in clinical trials (~34% CAGR) and show that these products have been used across all phases of research and by a diverse group of trial sponsors. We identify four distinct use cases for how such connected products have been integrated within clinical trial design and suggest implications for various stakeholders engaging in clinical research.

Keywords: Clinical trials; Outcomes research.

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Conflict of interest statement

Competing interestsA.C. is the CEO of Elektra Labs. The rest of the authors declare that there are no competing interests.

Figures

Fig. 1
Fig. 1. Defining “connected digital products”—inclusion criteria.
Products must meet all six of the criteria labeled along the top of this figure in order to be included in this study as “connected digital products”. Products that fail to meet any one of the six criteria are excluded.
Fig. 2
Fig. 2. Clinical trials using connected digital products by study start year and phase.
Each bar represents the total number of clinical trials started annually that include a connected digital product. The trials are segmented by phase, as designated in the ClinicalTrials.gov record.
Fig. 3
Fig. 3. Most frequently used connected digital products.
a The most commonly used connected digital products during the 4 years prior to the iPhone launch are reported with statistics describing the number of trials and key characteristics of the trials for each product during the period 2004–2007. b Similarly, the most commonly used connected digital products during the most recent four years of our data, 2015–2018, are described.
Fig. 4
Fig. 4. Classifying connected digital product use in clinical trials.
Connected digital products are used in clinical trials in four unique ways. Each method of use is described and an example trial from this study’s dataset is included.
See this image and copyright information in PMC

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