Dive Brief:
- Japanese drugmaker Takeda Pharmaceutical hopes to boost the use of digital health tools in several early-stage clinical studies, inking a collaboration deal with the tech company Koneksa Health on Monday.
- The deal will give Takeda access to Koneksa's biosensor and wearable technology which will allow for remote collection of patient data, such as activity level and information on sleep patterns.
- Digital health tools are still relatively new, and so Koneksa and Takeda hope the collaboration will help validate digital clinical assessments, or "digital biomarkers."
Dive Insight:
Clinical trials are expensive to run, and so companies are always looking to improve data-collection in the most cost-effective way possible, or, if necessary, make clear go/no-go decisions sooner in clinical development.
By tracking vital signs, activity levels and sleep metrics in real time, Takeda aims to develop 'digital biomarkers' and a better understanding of disease progression. In time, Takeda hopes, these digital markers could become new endpoints to measure patient function outside of traditional clinical settings.
"Working with Koneksa enables us to take advantage of technologies and expertise that provide access to novel data streams and make our clinical trials more patient-centric," said Elena Izmailova, senior director of Novel Data Streams and Devices at Takeda.
"Koneksa’s end-to-end solution allows us to collect this data in our studies using Koneksa’s sensors and devices."
One of the challenges of a clinical trial, especially when it is conducted in a setting nearer to a real-world environment, is ensuring patients take the right dose at the right time. Noncompliance can affect clinical trial outcomes by masking signs of efficacy. It can also change side effect patterns, as missed doses could cut the adverse impact, or even make them worse. In addition to improving patient experience and clinical effect detection, Koneksa's technology could also improve compliance through reminders and patient-reported data.