Although technology provides vast opportunities to improve clinical trial efficiency and unlock new patient insights, many sponsors and CROs struggle with the operational complexities of adoption and deployment. The team at ActiGraph has spent years working closely with study teams to incorporate wearable digital health technologies (DHTs) into their research. We're intimately familiar with the multitude of operational considerations that can impact the success or failure of a remote DHT assessment.
In order to accomplish the ultimate goal of patient-centered drug development, the study design, which includes DHT implementation, should be prioritized around the needs of the participants. Sponsors must carefully consider how and why DHTs are being used in a study, and they must ensure this information is effectively communicated to participants. It doesn’t matter how sophisticated a wearable device may be – it’s worthless if the participant doesn't wear it.
When executed correctly, wearable DHTs enable researchers to directly and remotely assess how study participants function in the real world. Based on our experience, we’ve compiled this list of three important considerations for maximizing participant adherence and achieving operational success.
1. Help the Participants Understand the Technology
Don’t underestimate participants’ willingness to adopt new technology. The key is helping them understand the purpose of the DHT and taking the time to properly explain how to operate it.
To keep participant burden to a minimum, make compliance as easy as possible for the participants’ day-to-day. With the use of near real-time remote data collection, the protocol’s design can focus on capturing the meaningful timing of changes, beyond just the typical clinical trial milestones, such as site or clinic visits.
2. Choose the Correct Devices
When selecting a DHT, ensure the capabilities of the device are appropriate for the particular study objectives and patient population. Signals in the collected data can inform and provide insight into the participant's treatment response. In addition, there are other signals that can be seen in the overall data (such as activity trends or sleep trends) that may not be associated with treatment but are still meaningful.
Also, ensure the DHTs are easy to use and pose minimal intrusion on participants’ daily activities. For studying disease progression over time, consider capabilities for long-term deployment such as battery life and remote data capture mechanisms.
3. Anticipate Participant Needs
Participants don’t always reach out to the site when they encounter an issue, so eliminate potential challenges wherever possible. For example, passive data uploads from an in-home hub may produce better results than requiring the use of an always-connected phone.
For long-term use, speak with your technology provider about how disease progression could impact participants’ ability to use the DHT.
These are just a few strategies that help our clients successfully deploy DHTs into clinical studies. For more in-depth information on achieving operational success, watch our free on-demand webinar, “Operationalizing Digital Health Technologies: Successes & Failures in Clinical Research."