Study suggests wearables offer advantages over traditional methods
NEW YORK, Oct. 1, 2019 /PRNewswire/ — Koneksa Health, a private company that enables the biopharmaceutical industry to develop new medicines using digital biomarkers and novel clinical endpoints, announced today the publication of a peer-reviewed manuscript demonstrating the utility of wearable devices for monitoring clinical-trial subjects for physiological changes and pharmacologic responses.
The paper, titled “Continuous Monitoring Using a Wearable Device Detects Activity-Induced Heart Rate Changes After Administration of Amphetamine,” has been published by the peer-reviewed journal Clinical and Translational Sciences, and was authored by researchers from Takeda Pharmaceuticals and Koneksa Health.
“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, Takeda.
This publication reported on an exploratory component of a Phase I study of an investigational drug. The results demonstrated the utility of wearable devices for vital-sign data collection and interpretation, and the advantages of collecting dense continuous data over extended periods of time.
“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.”
The study can be read in full at https://ascpt.onlinelibrary.wiley.com/doi/pdf/10.1111/cts.12673
Koneksa Health is a private company that enables the biopharmaceutical industry to develop new medicines with fewer patients. By unlocking the potential of real-world data from remote, wearable, and other digital technologies, Koneksa speeds up the time required to understand how a drug is working and helps to develop real-world evidence for how medicines can impact the daily lives of patients.
For more information, please visit https://www.koneksahealth.com
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