Marc Sebes, VP of Product Management, Validic

The growing adoption, sophistication and connectivity of clinical device

In-home clinical devices are among a number of digital health technologies that are being used to streamline clinical trial processes and enable pharmaceutical companies and contract research organizations (CROs) to monitor participants remotely. As partially or fully remote clinical trials gain market momentum, these particularly impactful devices enable the remotely collected participant data to be integrated into a clinical trial system, patient community application or engagement platform. Researchers and clinicians are then provided with access to real-time participant data at a reduced collection cost.

Clinical devices are instruments, implements or machines intended for use in the diagnosis of disease or monitoring of conditions. Examples of commonly used in-home clinical devices include blood pressure cuffs, blood glucose meters, sleep tracking devices, spirometers and weight scales.

Three factors have led to the increased usage of these devices in clinical trials. First, the escalating competition caused by new entrants providing in-home clinical devices has led to better usability and accuracy from all vendors. Second, as evidenced by the specialized digital health displays in retail stores like Target, consumer demand and adoption of in-home monitors is growing. Third, as data from these devices has become more accessible for clinicians, the value of utilizing these devices in trials has increased.

Delving further into the increased value of real-time connectivity, the previous lack of device connectivity in the market placed a substantial burden on trial participants and researchers required to routinely collect data. Previously, patients were required to either manually record the readouts or take the device to a trial site for the data to be downloaded by a clinician. This made conducting effective remote clinical trials nearly impossible; mandating participants to self-report data multiple times a day is not only an inefficient means for data acquisition, but it also greatly heightens the risk of incomplete and inaccurate data being provided to researchers.

Today, however, devices are becoming increasingly connected via Bluetooth Smart technology or application program interfaces (APIs). This growing device connectivity is enabling data to pass wirelessly in real-time from a blood pressure cuff, for example, to a smartphone and into the clinical trial’s platform or system. Unfortunately, some widely-used legacy devices remain unconnected. To bridge the gap, new data capture technologies have been developed to quickly digitize biometric readings from non-connected devices. Validic’s VitalSnap, which leverages optical character recognition (OCR) software, enables participants to capture health data via their smartphone’s camera from non-connected medical devices and automatically transfer it to a clinician. This provides researchers with the ability to access data from devices that are already clinically validated and being used in the trial.  

As clinical devices continue to mature and are integrated into the connected health ecosystem, they will become an increasingly vital component for creating better results for both clinical trial participants and sponsors. Regulators expect clinical devices that generate these data to meet certain standards, therefore most are FDA-approved Class II devices that follow the 510(k) pathway. And, the data generated by these devices are generally accepted in clinical trials.

In-home clinical devices are already benefiting and supporting trials today. As data is delivered in more real-time, there is less need for participants to spend time at sites. Additionally, in-home devices allow for more frequent empirical data to be collected throughout the trial. Utilizing the increased number of readings, additional correlations can be drawn from patient-reported outcomes, resulting in less uncertainty and more confident results.

In summary, connected in-home clinical devices are allowing for more passive data collection that enables participants to have a more active and engaged role in clinical trials, leading to better results at a lower cost.