- A major pharmaceutical company is introducing wearables to its clinical research.
Japan’s Takeda Pharmaceutical, whose focus is on vaccines, oncology, gastroenterology and central nervous system therapies, is partnering with mHealth company Koneksa to collect vital signs, antigraphy (motion, physical activity and sleep) and cardiac rhythm data in clinical trials now under way or soon to be conducted in the U.S. and U.K.
It’s the latest example of an industry taking a good, hard look at the patient engagement conundrum.
“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,” Elena Izmailova, PhD, Takeda’s senior director of novel data streams and devices, said in a press release. “Koneksa’s end-to-end solution allows us to collect this data in our studies using Koneksa’s sensors and devices.”
The announcement continues a recent push by the pharma industry to incorporate wearables and digital platforms in clinical trials, part of an effort to improve the industry’s relationship with the end-user. This past April, an Accenture survey indicated some 85 percent of pharmaceutical companies would be boosting their capital investment in patient-centered services over the next 18 months.
“Performance will be measured in a real-world setting, and that’s why pharmaceutical companies must sharpen their ability to quantify those results - both for patient value and for sustaining internal investments in these programs,” the company noted in its report.
”Market leaders will focus on capturing the impact of their services, use this information to adapt what they provide and differentiate from competitors beyond the therapeutic benefits of their drugs.”
For Koneksa, a New York-based startup developing wearables, sensors and Electronic Clinical Outcome Assessments (eCOAs), the goal is to connect the researcher to the patient in real-time. Finding out how a drug works or doesn’t work goes a long way toward developing a drug that a consumer will take and keep on taking as needed.
“Wearable technology and remote, electronic patient data capture are valuable tools for fortifying research with a sound foundational framework,” the company said in its press release announcing the Takeda partnership. “The study of disease progression or treatment effects, along with the safety profile of new drugs, necessitates new forms of data collection beyond the traditional patient-investigator rapport.”
It also involves creating a partnership of sorts between researcher and patient.
“In this strenuous clinical trials atmosphere, the vital experience of patients must be considered and appropriately captured,” Jahnvi Patel, a clinical operations associate at Koneksa Health, said in a recent blog. “Patient safety in terms of empirical clinical data should be supplemented with electronic patient-reported outcomes.”
“It is crucial to get direct symptomatic input from the patients regarding their health status during the development of drugs,” Patel continued. “In cases where clinical outcomes such as breathlessness, neuropathic pain, and sleep disturbances are experienced outside of the clinic, obtaining symptomatic data regarding the unobservable events is best taken from the patient directly.”
Koneksa is one of several mHealth companies looking to improve that connection to the patient. Some are working with wearables, such as smartwatches, smartglasses or sensor-embedded clothing, while others are testing patches, tattoos, even ingestibles. While giving researchers access to real-time data, they also offer insight into a patient’s daily routine.
This may help researchers understand what a patient is feeling, and prompt pharma to look beyond the digital platform to the person at the other end.
“As product developers who invest significant time and energy in what we build, it is easy to assume our designs are intuitive to our customers,” Matt Cantor, Koneksa’s vice president of business operations, said in another blog. “However, remaining in our own bubble can lead to building siloed tools that fail to appreciate the context in which they are used. Taking time to listen to the stories of the people who commit to participating in medical research and use our solutions is a critical important part of our process.”