Koneksa Health, a New York-based healthcare company focused on making clinical trials safer for its participants, just published a peer-reviewed manuscript showing the benefits of wearable devices for monitoring clinical-trial participants for physiological changes and assessing their responses to the medicine.
The paper, authored by researchers from Takeda Pharmaceuticals and Koneksa Health, was published in the journal Clinical and Translational Sciences.
“This study demonstrated the importance of robust clinical assessment of wearable digital sensors so that their performance can be determined relative to the in-clinic 'gold standard' measures. Additionally, understanding the differing performance of sensors under a range of potential use conditions, such as were undertaken in this study, is equally as important,” said Anne Heatherington, Senior Vice President, Head of Data Sciences Institute at Takeda Pharmaceuticals.
This publication reported on an exploratory component of a Phase I study of an investigational drug. The results showed the usefulness of wearable devices for vital-sign data collection and interpretation, and the advantages of collecting dense continuous data over extended periods of time, said Koneksa Health in a press release.
“This was a collaboration in a true sense of the word: all team members involved share a belief in the important potential of digital technologies in drug development,” said Elena Izmailova, Ph.D., Chief Scientific Officer at Koneksa (formerly Senior Director of Data Science, Takeda). “Few published studies to date have investigated the use of wearable devices in clinical trials with detailed data analysis. Our research is contributing to building that body of evidence.”
Koneksa enables collection of real-world data from remote, wearable, and other technologies in order to speed up the time required to understand how a drug is working and helps clinicians understand how medicines can impact the daily lives of patients.