I love a good buffet as much as the next person, but the current COVID-19 environment is not the only time a buffet might be problematic; it can also prove challenging when selecting a device for your clinical trial. Buffets work well when abundance is the goal, but when you’re focused on a specific objective, the seemingly limitless options may become distracting, overindulgent, and ultimately leave your needs unmet. At Medable, we’ve seen our fair share of device buffets, and we want to help you avoid choosing something that’s been sitting under the heat lamp for too long.
COVID-19 has accelerated the need for decentralized clinical trials and adoption of wearable devices for remote patient monitoring. Connected device data is helping transform healthcare across the world, and the benefits of this approach are well documented. If you’ve already decided that wearable devices are a great fit for your trial, but you’re not sure how to pick the right device out of a selection of hundreds of options, the information below may help. We actively canvas and assess the connected device market, and wanted to share the top factors our team reviews to determine our device catalogue.
Top 5 Factors to Consider when Selecting Connected Devices
Security: How is data captured, securely transmitted, and stored?
Accurate and secure data capture is of paramount importance. Finding a reliable device that can not only accurately capture the data, but securely and timely transfer that data to a compliant database is a must. If the device has the proper integration capabilities, it allows the device to seamlessly pass that data directly into a 21 CFR Part 11 or GDPR compliant database, like Medable’s, so it is never exposed to a security risk.
Some devices require their data be transmitted to their own database or application, which in turn may require a sponsor to qualify the connected device vendors' app and database as well. This can be costly and take a lot of time, and more importantly, some of these device vendors don’t have databases or applications that meet the strict storage and security requirements that this industry requires.
Usability: Is the device easy for a patient to set up and use?
Selecting a device that’s intuitive for a patient to use is critical. If it’s difficult for a patient to use the device or upload the data from it, they likely won’t. Clear, step-by-step instructions should be included for patients to reference when they take measurements or for them to consult throughout the study. Even seemingly small things, like devices that require a cord to connect to a phone or to download data, can be a barrier for patients and result in incomplete datasets.
The best solution is to integrate the device right into the ePRO solution they are already using on a daily/weekly basis for their trial, so the data automatically uploads during use. We’ve seen much higher compliance with this approach, and as a result it’s our standard set up.
Dashboards: How is the data captured displayed and reported to patients or the study team?
Many connected devices don’t actually show patients the data they capture. If you are collecting steps or blood pressure on a daily basis, and it's possible to share the data, patients prefer to see their data. Presenting this data (where applicable) can lead to higher engagement and adherence, adding an element of gamification and stickiness to your study for the participants.
Presenting daily data back to your patients can lead to higher engagement and adherence, adding an element of gamification and stickiness to your study.
Reports and dashboards for patients and study teams help with monitoring study progress. A valuable approach is to set alert ranges on the data that is collected, which can trigger notifications to the study team to proactively identify a patient that might need attention. Examples include setting triggers for blood pressure, heart rate, temperature, or weight changes.
Regulatory: Is the device approved and cleared for use in the countries in your trial?
Make sure the device you select has the proper approvals and certifications (examples: 510k cleared, medical grade, CE mark, etc) for how you intend to use it. Additionally, you will want to inquire whether there are country or region specific versions of the devices (some manufacturers standardize globally, while some create a device specifically catered to a region). Sometimes simple things, like providing the right charger/adapter for all countries that will use the device, are critical to successful use of the device in your trial.
Support: Will support for the device exist throughout the duration of your trial?
Technology and devices iterate and change quickly, and during a long study, the manufacturer may not support a device for the duration of your study. In those cases, technical support for that particular device ceases to exist in the market.
At Medable, we continue to proactively research the market to identify reliable, easy to use devices to add to our library of tested and approved devices. If you’re not sure which device to use, we’d be happy to provide our insight and help you with your “buffet” selections. You can send us an email at firstname.lastname@example.org