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From text messages to mobile apps, digital health devices are becoming increasingly important in clinical trials for their ability to streamline trials, lower site burden, and improve the patient experience. However, manufacturers must consider the safety, reliability, and convenience of these devices in order to effectively implement them into medical device trials. The digital components of these medical device trials must adhere to the same rigorous regulatory standards as the device itself, which can pose significant hurdles for some sponsors.
Digital Health Device Opportunities
In these types of clinical trials, patients interact with devices that collect data that are essentially digital biomarkers. The data are then transmitted to the investigator site, where computers analyze the information to ensure study endpoints are being met and possibly provide new insights into the safety and efficacy of the medical devices. These digital biomarkers can then be used to explain, predict, or influence health-related outcomes.
Not only are digital health devices sources for crucial information, but they provide opportunities for improvements across medical device clinical trials. For patients, they make trial participation easier while also improving adherence. For sites, the devices can facilitate recruitment, as they allow staff members to easily interact with potential patients in a timely manner. This may lead to accelerated timelines and reduced costs for sponsors, which are critical goals in a highly competitive environment.
Challenges in Adopting Digital Health Devices
Manufacturers need to be aware of the challenges that come with incorporating a digital health device into a medical device trial. If they are prepared for these challenges, they will be able to better design devices that will lead to successful trials.
Many of the challenges are regulatory. FDA Commissioner Dr. Scott Gottlieb recently announced that the agency will increase its focus on digital health devices next year. FDA is working to ensure digital biomarkers are consistent through certification of firms and developers. The goal is for platforms to be verified as responsible and safe, so future regulatory reviews of future updates can be minimized. The Clinical Trials Transformation Initiative (CTTI), a partnership co-founded by Duke University and FDA, is also working to create a framework for greater adoption of sensors and digital biomarkers in clinical trials through a collaborative effort with the pharmaceutical industry, regulatory agencies, contract research organizations, and technology providers.
It is vital that the device measures and stores data accurately and transmits those data securely and that the endpoints are appropriate. Additionally, sponsors should plan for every educational level, computer savviness, and cultural variance when utilizing these new digital devices. To reach these goals, both sponsors and digital health device developers should consider the following guidelines for incorporating digital health devices into clinical trials:
- Usability and Accuracy. Sponsors must be able to determine that a device is providing the desired endpoint values in a trial. The metric should be accurate and presented in a usable format.
- Safety. The manufacturer should be able to provide highly secure methods for transmitting data between the digital health device and the analysis site.
- Convenience. The manufacturer should be able to provide logistical support to decrease the site and subject burden. They should also be able to provide full documentation of engineering verification for the devices.
- Ease of Use. It is important to consider how the patient will interact with the device. It needs to be an appropriate size and weight, and it should allow the patient to move and behave in the same way he or she normally would.
- Reliability. To maintain data continuity, the device should have a battery life sufficient to allow it to collect data for long periods of time with minimal glitches.
Moving forward, medical device developers and sponsors must consider the increasing regulatory requirements and be able to demonstrate technical value. Following these guidelines will improve the application of digital health devices into medical device trials, expanding opportunities for the future of research.