Capitalizing on sensors in clinical trials

Capitalizing on sensors in clinical trials

BY Nathan Noakes, Solutions Architect & Program Director, Scientific Data Organization Keith Wenzel, Senior Director, Parexel's Scientific Data Organization - 9.20.21 -

A decade ago, few people owned wearable technology. Today, fitness trackers and smartwatches are everywhere. As public comfort with wearables has grown, sensors have become more common in clinical trials as well. Some estimates predict that in under five years, up to 70 percent of all protocols will include sensors.[i]

Patient-centric sensors collect data, often passively, during a person’s daily activities in his or her usual environment. These devices — which include pulse oximeters, activity trackers, glucometers, and spirometers, among others — can significantly reduce patient burden, making patients more likely to enroll in trials and remain adherent to protocols. Sensors also help reduce trial costs and allow for more study endpoints, thanks to the frequent or continuous capture of real-world data.

Here’s the challenge: Device manufacturers deliver innovation but are often unequipped to meet the needs and requirements of sponsors. Regulatory approval doesn’t guarantee that a device will be easy to use or to include in a trial.

That’s why sponsors often enlist a CRO to handle sensor integration. At Parexel, our sensor team takes partners from device selection to deployment — ensuring the collection of valuable data and reducing the burden on patients, sites, and the sponsor.

When building sensors into a protocol, a sponsor or CRO needs to manage multiple technical and logistical considerations as well as therapeutic concerns. For every integration, it is critical to:

Assess the technology. Before including a sensor in your trial, you’ll want to audit its security and data integrity, then validate the device and its software platform. For us, that means we wear the sensors for a few weeks to check out their comfort, battery life, and ease of use. Then we review the data we collect, consulting with statisticians to ensure its usability. Following our SOP for selecting, qualifying, and validating sensors, we measure each device by the same rigorous standard.

 Address indication-specific needs. It’s important to tailor deployment strategies to specific patient populations. For example, when integrating a continuous glucose monitor, we would recommend a solution that overlays sensor data with established patient-reported outcomes and physician assessments. Data are most valuable within context. In this case, knowing when a patient used insulin or consumed carbs informs the sensor data — and when all data are shown in a single place, that holistic view allows for greater insights.

Map the patient journey to encourage compliance. Sensors must fit both the protocol and the patient’s lifestyle. A device can’t add value if patients don’t use it correctly, so set them up for success. Take battery life, for instance. Since frequent charging hinders compliance, it’s important to consider a device’s battery life against the length of the observation period. Maybe you need a sensor that stays charged longer. Or perhaps you’ll want to modify your requirements. A sensor might be capable of collecting 120 data points per second — but is that much data really necessary? Reducing the rate to one data point per second would extend battery life significantly, improving adherence. You need to closely examine and balance those tradeoffs.

You’ll also want additional patient supports in place. For example, Parexel creates trial-specific patient training materials and provides wrap-around services to monitor and encourage compliance.

Develop a data collection strategy. To get the most from sensors, arrange for vendors to send raw data from devices. You can then apply algorithms and data analysis post-collection. In addition, you or your CRO can also apply pre-determined algorithms during collection. In our engagements, vendors export all data directly to the sponsor.

Manage supply and logistics. Device vendors often lack expertise in global distribution or clinical project management. When we handle device integration, we take responsibility for regulatory requirements, device shipping and import, and inventory replenishment. Sensors aren’t the same as a syringe or saline bag, so plan for every possibility: late deliveries, extra setup time, the return of reusable sensors. And keep vendors accountable. Creating governance structures and service level agreements will help.

A CRO should also standardize delivery to make the process faster and more scalable. In our engagements, we frequently integrate actigraphy monitors. These wearable sensors, usually housed in a wristband, can monitor general movement, levels of vigorous physical activity, sleep patterns, and adherence. With one sponsor, we’ve developed and implemented standards that reduce start-up times by 40 percent because we’ve predetermined requirements and processes for their deployment.

Ready to include more sensors in your trials? An integration partner can save you time, money, and frustration by:

  • Mitigating and managing risk and complexity.
  • Increasing data integrity and usefulness while reducing patient and site burden.
  • Offering expertise on evolving regulatory requirements, emerging industry standards, and patient needs.

While sensors can certainly enhance a trial, they require planning, oversight, and ongoing monitoring. The right CRO partner will own those responsibilities. Because it’s not enough to put sensors in patients’ hands — sponsors need a comprehensive strategy for maximizing their value and making them simple to use.


[i] https://www.intel.com/content/dam/www/public/us/en/documents/solution-briefs/transforming-clinical-trials-with-the-power-of-ai-brief.pdf

 

 


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