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Applied Clinical Trials
The next decade should see new technological solutions that improve data collection for clinical trials, with geofencing looks leading the way.
One of the biggest threats to the success of a clinical trial is missing patient data related to adverse events. Without all the essential data, it becomes difficult to demonstrate a drug’s safety and efficacy, raising the odds of failure. Yet the problem is common. In a recent survey1 of 413 cardiovascular clinical trials, 70% were missing crucial outcome-related data.
Why is so much data missing? One reason1 is that when studies only use traditional technologies for a large-scale, long-duration clinical trial, it is nearly impossible to track every significant event such as an illness or hospitalization. Medical records are expensive and time-consuming to review. Data entry into electronic data capture (EDC) systems often lags behind real events, making timely follow-up difficult or impossible. Participants2 often forget to provide updates on their health status, and they may seek care at facilities that are not monitored by the study. As a result, huge amounts of data are lost, a drug’s efficacy is poorly understood, and studies fail unnecessarily.
Geofencing-the same mobile technology that sends you a pop-up message3 from Starbucks when you are nearby in the shopping mall-automates certain clinical trial reporting based on location data, reducing the risk that study managers will miss critical events.
In clinical trials, geofencing operates by placing virtual fences around hospitals, medical facilities, doctor’s offices, or anywhere that an adverse event might be reported. Participants download an app to their smartphones, which then alerts study managers whenever participants enter a geofenced location. Computer algorithms distinguish outpatient visits from inpatient visits, ED visits from clinic visits, and doctor’s visits from clinic visits, and the app reports all of this in real time. If clinical study managers want to know more about a medical visit or offer their assistance, they can chat with participants directly through the app.
Thus, geofencing lets study managers capture the time, date, and nature of all medical interactions. In a flu vaccine trial4, for example, tens of thousands of participants in a wide geographic area are monitored for months, noting every symptom, urgent care visit, doctor’s visit, and hospitalization. Thousands of these events typically go undetected, but geofencing can change that. By some estimates, the technology may reduce adverse event data loss in the next two decades by up to 90%.
With any app that involves location tracking, privacy is an important concern, and informed consent is critical. Studies5 indicate that patients are open to location tracking for a good purpose. One major advantage of geofencing over other location-tracking methods is that it only records data when participants enter or leave a geofenced location. It does not track participants’ movements outside of those sites, making geofencing particularly attractive from the standpoint of patient privacy and data security.
The stakes are very high for collecting clinical trial data. Pharmaceutical companies spend millions on increasingly complex clinical trials, making it essential to maximize efficiency. Onerecent study6 from the Tufts Center for the Study of Drug Development put the average price tag for a drug’s clinical trials at about $340 million, up from about $130 million in 2003.7 And while costs are rising, success rates are falling. In the latest Tufts study, a drug had less than a 12% chance of making it through all three trial phases to win FDA approval, down from 21.5%.
The next decade should see a host of new technological solutions that improve data collection for clinical trials, reducing costs and raising completion rates. Geofencing looks ready to lead the way to better, cheaper trials-right now.
Paul Glimcher PhD, President and CEO; Jennifer Cho, PharmD, Deputy CSO of Datacubed Health.