Geofencing as the Next Advancement in Clinical Trials
The good news today is that applying consumer technologies to health studies offers attractive solutions to some of the biggest challenges in real-world use and clinical trials – including unreported and undetected participant data.
Unfortunately, false perceptions commonly pervade some of the most promising technologies currently on offer. And ignoring the facts can mean missed opportunities. That is certainly the case with geolocation.
Geolocation can significantly reduce the risk of missing critical health events, while also improving the experience of patients, in a clinical trial for a new therapy. Geolocation, or more specifically, “geofencing”, allows study sponsors to identify and “fence” healthcare facilities within a participant’s range of activity. An app, downloaded to the participant’s own smartphone, uses cell tower triangulation, WiFi, and telemetric data to alert the participant and clinical sites whenever the participant enters a geofenced location. A critical read-time symptom survey is sent as the participant leaves the clinic and that information is automatically logged into a safety case tracking system. Sites can follow up with the participant to obtain additional information that might be relevant to the trial, or to provide useful insights about the disease under study.
Most important, the participant – who might well be experiencing an adverse event – feels the information that he or she is providing is useful and timely and that someone is looking out for their care. In short, geolocation technology is a promising solution to the chronic issue of under-reporting of significant health events in clinical trials and health-related studies.
Yet, despite its potential to improve the data quality of clinical trials, misconceptions abound. Let’s take a look at five of the most common.
The Five Misconceptions
Geolocation technology cannot be used to run a study in pharmaceuticals because of data privacy issues.
Fact: Use of the app is agreed upon by both patient and sponsor during the consent process; participants opt-in, just as they would when using a consumer app involving location services. Further, use of geofencing in clinical trials will be approved by the IRB.
Personal data about an individual’s movement can be shared and exploited.
Fact: Detailed location information identifying the geographic locations of hospitals, doctors’ offices, homes, or other healthcare facilities are loaded into the app and stored on the phone. Participant interactions with multiple locations can occur while keeping the location data on the device. This is very similar to the Apple privacy model whereby key information is kept only on the phone. Continuous longitude and latitude is not uploaded to the cloud. Only geofence breach information is used to issue new symptom surveys.
Patients will not consent to any use of geolocation, even if their privacy is assured.
Fact: Anyone who has used a smartphone to get directions from a certain point, hail a ride on Lyft, or download coupons when close to a favorite coffee shop has consented to sharing their location with a commercial entity. Just as consumer app users have shown a willingness to share personal information if they feel they’re benefitting in some way, studies indicate that patients are also open to location tracking if they believe it is for a good purpose. Indeed, large pharmaceutical companies are already successfully utilizing this technology in their studies.
The location data is not accurate and will be marred by inaccurate timing of when surveys are received.
Fact: Depending on the study’s needs, several complementary approaches can be deployed to ensure that false readings are kept to an absolute minimum.
To avoid an event being logged and an alert triggered when a participant is simply passing through a geofenced location, a minimum time duration threshold can be imposed. For example, the participant must be in the area for longer than ten minutes to trigger a logged event.
This technology is not relevant to most studies.
Fact: In cardiovascular trials, important patient outcomes – including death – were reported only 23% of the time¹. A recent survey of 413 clinical trials found that 70% were missing crucial outcome data, largely as a result of underreporting adverse events.
And while the most obvious use of geofencing relates to participants’ activities outside the home, what about detecting when a participant is less frequently leaving the home? This could indicate an unreported illness, or in the case of depression, this could objectively indicate fatigue.²
In truth, the accurate detection of critical events, such as illnesses and hospitalizations, presents an ongoing challenge for sponsors of clinical trials and other health-related studies. The limitations of self-reported patient information, which suffers from low reliability and low accuracy, can lead to the ultimate failure of the study.
Sophisticated solutions using advanced digital technology add another exciting dimension to automating patient-reported outcomes – and ultimately, can help reduce study costs and speed time to market for new therapies.
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1 Heneghan C, Goldacre B, and Mahtani KR, Why clinical trial outcomes fail to translate into benefits for patients, Trials. 2017; 18: 122. doi: 10.1186/s13063-017-1870-2
2 Swindle R, Kroenke K, Braun LA (2001). Energy and improved workplace productivity in depression. In: Sorkin A, Summers K, Farquhar I (Eds.), Investing in Health: The Social and Economic Benefits of Health Care Innovation (vol. 14, pp. 323–341).