Findings demonstrate the importance of analytical and clinical evaluation in the applicability of wearable devices in R&D

NEW YORK, Feb. 5, 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 that researchers, including staff from Koneksa Health and Takeda Pharmaceuticals, have published a peer-reviewed manuscript describing evaluation of wearable digital devices in the context of a clinical trial.

Published in the January 2019 issue of the journal of Clinical and Translational Science, the paper, titled “Evaluation of Wearable Digital Devices in a Phase I Clinical Trial,” analyzes the performance of two wearable devices in a Phase I study according to the “fit-for-purpose” principle and highlights the need for device evaluation according to intended use regardless of the regulatory status.

“This paper is one of the first steps towards adopting wearable technologies in clinical development to bring much-needed medications to patients,” said Elena Izmailova, Ph.D., lead author of the paper and Chief Scientific Officer at Koneksa. “It’s one of a few publications that study wearable sensors in a real-world environment for the purposes of drug development, highlighting the benefits, as well as the challenges, of collecting wearable sensor data.”

Wearable digital devices have the potential to offer dense continuous data collected in a natural environment as people go about their daily life activities at home and work. Dense vital sign data can improve understanding of variability of certain medical conditions and treatment response, provide a more complete picture, and reduce the number/duration of hospital visits.

But while these devices hold the potential for more information with less difficulty, the selection of the appropriate device for a study can pose challenges. Selected devices should be appropriate for an intended population, their performance needs to be verified, the behavior and limitations of data understood, and last but not least, they should be acceptable to the study subjects.

The study evaluated whether two devices, a wrist-worn actigraphy device and a single-lead ECG device, were suitable for vital-sign data collection and capture of physical activity, in the context of an early-phase drug-development study. The authors concluded that, while the devices were acceptable to the study subjects and the site personnel, the results illustrated the critical role for rigorous evaluation of device performance, writing: “For wearable devices to gain wider applicability in drug development, we need to develop and establish acceptance for common issues, including medical need, device choice, context of use, fit-for-purpose validation, and predefined operational requirements, as well as data collection, processing, and interpretation.”

“We sought to highlight the need for scientific rigor in selecting devices, designing experiments, and interpreting the data,” said Dr. John Wagner, MD, PhD, a senior author of the publication and sVP of early clinical development at Takeda. “It’s especially important to emphasize the practicalities of this work, and to be transparent about the challenges. In this field, it’s easy to encounter a great deal of hype, which can create unrealistic expectations and derail real scientific progress.”

The study can be read in full at

About Koneksa Health

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.

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About Takeda Pharmaceuticals, U.S.A., Inc.

Takeda has maintained a strong and growing commitment to the United States for more than 50 years. On January 8, 2019, Takeda completed its acquisition of Shire, PLC, becoming a global, values-based, R&D-driven biopharmaceutical leader. In the U.S., Takeda employs more than 18,000 employees across multiple business units, and as of August 2019, will be headquartered out of the greater Boston area.

Additionally, Takeda also has a research facility in San Diego, California, specialty products manufacturing facilities in Brooklyn Park, Minnesota and plasma fractionation manufacturing facilities in Covington, Georgia.

As one of the world’s leading biopharmaceutical companies, Takeda is committed to bringing Better Health and a Brighter future to people worldwide. We aspire to bring our leadership in translating science into life-changing medicines to the next level, in our core focus areas; oncology, gastroenterology, neuroscience, rare diseases, plasma-derived therapies, and vaccines.

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