Connected digital products offer enormous potential to transform the way clinical research is designed and conducted, and researchers have increasingly recognized the benefits of using these products in clinical trials. Instead of capturing data only when a patient is in a controlled setting such as a clinic, connected digital products can gather patients’ real-time behavioral and physiological data at a distance and with only limited clinician involvement. Not only can this type of measurement augment clinical studies with more robust data collection, but it can also enable the use of novel digital biomarkers, remote patient monitoring, and decentralized clinical trials.
In recent weeks, the potential benefits of these new approaches have become increasingly salient with the disruption to more traditional clinical trial protocols caused by the COVID-19 Pandemic. In fact, on March 27th, the FDA issued new guidance that encourages researchers to use remote patient monitoring technology when possible in order to safely continue clinical studies during the pandemic, making the study of such tools in clinical research especially germane.
How frequently are connected digital products used in clinical trials? Though recent news has underscored the value of these products in enabling new data collection models, there is limited large-scale data on how connected digital products have been implemented in clinical research to-date. In our paper, we answer this question by quantifying the growth of connected digital product use across 18 years of clinical trials.
Because a host of related terminology has been used to describe connected technology and its many applications within digital health, we ground our study in a clear definition of “connected digital products”. Our inclusion criteria require that products measure health-related data, have a software component, include a sensor element, are portable and connected (via WiFi, Bluetooth, USB), and are designed for patient use with little to no clinician involvement required (Fig. 1).
To identify the set of clinical trials that used connected digital products, we created and validated a set of search terms derived from detailed lists of product types as well as specific product model and manufacturer names. We then applied a text search algorithm to the full set of records from ClinicalTrials.gov to generate a dataset of trials that used at least one connected digital product during our period of study. In analyzing these trials, we documented substantial growth in the use of connected digital products over time, with a compound annual growth rate of approximately 34% from 2000 through 2017 (Fig. 2). Further, we find that connected digital products have been used across all phases of clinical research and have been incorporated in trials sponsored by both industry and non-industry organizations.
In the paper, we provide details on the types of connected digital products most used in clinical trials and highlight specific changes after the launch of the first iPhone. We also describe four unique ways in which clinical researchers appear to be using connected digital products within clinical trial protocols and suggest implications for various stakeholders across the research ecosystem.
As the use of connected digital products becomes increasingly important for clinical trial efficiency—and in some cases, becomes essential for allowing trials to continue when in-person interaction between patients and researchers may not be feasible—we believe that a clearer understanding of when and how connected digital products are most commonly used will prove informative in future trial design and execution.
Acknowledgments: This post is in reference to the article “Quantifying the use of connected digital products in clinical research” with my co-authors Jacqueline Chen, Andrea Coravos, and Ariel D. Stern. Many thanks to Lila Kelso, Christine Manta, and Melissa Ouellet for excellent research assistance and to Feild Craddock for graphic design.