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Wearables are emerging as a solution for creating a more adept and effective clinical trial process. Although the technology is in an early phase, there are clear benefits of using wearables in the clinical trial setting such as computational power and predictive analytics tools which enable a volume increase of the collected data, and improved workflow processes and speed, which ultimately may lead to decreased health care costs while achieving faster times to market. The role of technology is to bring together disparate data sources, so the industry can share data and use advanced analytics to make better decisions. Let’s explore how data analytics and new clinical technology — such as mobile health solutions and wearable devices — may impact the way trials are conducted and how an increase in data equity and scientific knowledge may be achieved.

Many sponsors have integrated the data coming from wearable devices or smartphones and also CRO’s (Contract Research Organizations) look for ways to integrate the data into electronic data capture (EDC) systems. genae, a digital CRO with focus on medical devices, launched the INTEGR8 study in July 2015 to demonstrate and validate the integration of a wearable device (Microsoft Band, Microsoft) in an EDC (edc2go, genae). The INTEGR8 program combined:
- daily quality of life related questions
- sent from edc2go, and answers transmitted to a smart-phone (Bluetooth) and encrypted (3G/WIFI) to edc2go
- from 19 subjects across 4 countries
- with a follow-up of 1 month.

The study illustrated the possibility of storing and processing real-time data, from patient to data collection workflows. Not only did the study design demonstrate a 2-way communication between wearable and EDC; it also achieved a next level of intelligence by correlating data entries. Throughout the study, smart questions were triggered when subjects provided specific answers for 3 consecutive days. genae has already initiated two follow-up studies for 2016 to optimize the data collection workflows and to expand data collection with tracked quantifiable and objective metrics, such as subject’s heart rate and steps walked.

This novel technology is an important step towards simplifying the clinical study and routine follow-up workflow, enabling real-time assessment of the subject’s safety and reducing costs by limiting follow-up visits. Involving the subjects on a daily basis will ultimately increase their engagement during clinical trials and provide bigger and smarter data. From an investigator’s perspective, the integration of this wearable technology in data collection workflows may have a positive impact on compliance and on medical costs. It enables physician to closely monitor subject’s activity and/or drug intake, without waiting for the next scheduled follow-up visit at the hospital. Adherence to medication schedules, QOL indicators and pain scores are metrics that are captured today during telephone calls or follow-up visits. This technology may truly enable remote monitoring and ultimately improve patient outcome.