The shift towards using remote monitoring digital devices in clinical trials could threaten traditional CRO service offerings, experts said. But while site monitoring work is set to drop, there may be an outsourcing opportunity for companies offering statistical services for analysing the large volumes of patient data generated by wearable sensors, they said. However, operational and regulatory hurdles must be overcome before remote monitoring can be widely adopted in trials, they added.
Experts agreed pharma is moving away from a decades-old model of sending costly clinical research associates (CRAs) to trial sites to record patient data. Reducing “middle man” site-based work would cut expenses and input errors, if it could be replaced with video monitoring or sensors in wifi-enabled consumer devices such as smartphones or smart watches, they added.
Roche (VTX:ROG) and Prothena Biosciences (NASDAQ: PRTA) are conducting Phase I trials (NCT02095171 and NCT02157714) of antibody therapy PRX002 in Parkinson’s disease, which use an app on Samsung’s (LSE: SMSN) Galaxy S3 Mini smartphone to collect patient data, according to the companies’ websites. To supplement clinic visits, the studies are using the phones’ magnetometer, accelerometer and gyroscope to measure participants’ balance, gait, dexterity, and tremors during twice-daily tests, as well as passively monitoring movements throughout the day while phones are stored in patients’ pockets. Remote monitoring was introduced to track symptom fluctuations continuously outside infrequent doctor visits, provide measurements independent of physician perceptions, and increase trial adherence, said the companies.
Similarly, Proteus Digital Health, a company backed by Novartis (VTX:NOVN) and other corporate investors, is running several programmes for ingestible sensors embedded in oral tablets which can send information to an external patch on the stomach and from there, on to a phone via bluetooth to record patient adherence. An NDA submitted by Proteus and Otsuka (TYO: 4578) for a combination of the sensor with its he antipsychotic Abilify (aripiprazole) was rejected last week by the FDA, which required more data, although the regulator previously approved the sensor on its own as a medical device.