Digital Endpoint Usage is Skyrocketing, New Data Show
Sponsors have rapidly shifted from employing traditional endpoints to utilizing digital endpoints — outcomes measured through digital technology — to collect clinical trial data, according to the latest Impact Report from the Tufts Center for the Study of Drug Development (CSDD).
There has been a visible and rapid boost in the use of digital endpoints in clinical research since 2015, CSDD’s latest study shows, with the average yearly number of global trials using at least one digital endpoint more than doubling every three years since 2015.
Prepandemic, this number peaked at 12 digital endpoints per trial in 2018, but in the following 2021-2023 period, the use of digital endpoints rose sharply, with sponsors kicking off an estimated yearly average of 34 digital endpoint-utilizing trials. This number could be even higher, the center notes, as their study included only partial yearly data for 2023.
*Full year 2023 value is projected based on data for partial year
Source: Tufts CSDD
So far, 56 percent of digital endpoints are being used to support secondary trial outcomes, compared to approximately one-third being used for primary trial outcomes and 1.3 percent being used to support exploratory outcomes, CSDD found.
CSDD also found that more than half of digital endpoints require use of Internet-connected sensors, including activity monitors, chest contact sensors, heart rate monitors and ingestible sensors, while nearly one-quarter rely on continuous glucose monitors and just 11 percent use smartphone software apps or recording devices, including cameras and microphones.
The study also found that the average cost for a developer to create a digital endpoint ($21 million) is more than six times that of the sponsor cost to validate and implement a digital endpoint.
Access the full Impact Report here.
Stay tuned for the July issue of The CenterWatch Monthly, when we’ll dig deeper into the report’s findings and discuss its key takeaways. Subscribe here.
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