The number of wearable, connected medical devices (wearable devices) available for use in healthcare and clinical research has increased significantly over the past few years, making it challenging for clinical trial sponsors to know which devices would be most appropriate for their clinical trials. For example, when looking at activity monitors, there are a plethora of different devices available, ranging from commercially available actigraphy to specialized and medically approved devices. This article is designed to help sponsors consider which devices best meet their requirements when running a clinical trial.
First, let’s look at the opportunities that wearable devices offer for patients, sites and sponsors within clinical trials. These include: giving patients ongoing insights about their health; giving sites continuous information about patients that could potentially reduce the number of site visits; and helping sponsors design trial endpoints based on near real-time, continuous, home-based, real-world data, instead of the more traditional, infrequent, site-based data.
Now let’s look at some considerations that can help sponsors select the most appropriate device(s) for their clinical trials:
- What are the trial’s objectives? What are the endpoints and associated measurements and/or assessments?
- How have the devices been validated by the manufacturer, in terms of:
- data consistency, acceptability and scientific accuracy?
- intra- and inter-device validity?
- regulatory considerations?
- data transmission and interaction?
Once the opportunities have been evaluated, and the criteria for the best device selection have been reviewed, it is important to work with the right technology and CRO partner. Sponsors should ensure that device providers and CRO partners provide adequate data security and regulatory guidance. All the relevant regulations must be respected to ensure participants’ data are treated confidentially. The regulatory environment is constantly evolving, leaving room for further innovation. It can be daunting to be the first sponsor to use a certain device in a clinical trial, but employing the above considerations and getting the green light from the relevant regulatory body early on in the process can make the use of wearable devices an exciting opportunity.
Wearable devices are here to stay, and will keep developing to present more possibilities in clinical trials. But there is no need to wait before embracing them – the future of clinical trials is now.