While the pharmaceutical industry stands poised to plunge forward into patient connectivity – and thus begin to realize the enormous potential benefits for clinical trials – some decision-makers remain skeptical about bring-your-own-device (BYOD). There’s strong evidence that allowing participants in clinical trials to use their own smartphones to enter health outcome data can boost retention, enhance data integrity, and increase compliance. Yet today, BYOD is used in a small fraction of clinical trials. That’s enough to make you scratch your head.
The rate of compliance for studies with BYOD is estimated at 10-20% higher than for studies using a provisioned device, and the cost savings are huge. With BYOD, a user-friendly app is simply uploaded to the subject or caregiver’s phone and to the clinician’s tablet and deleted at the study’s conclusion.
As I see it, there is more to this reluctance than the traditional conservatism of the clinical industry stemming from the regulatory environment and patient safety concerns. Teams need to view business apps in the same way they do consumer apps. Let’s take a look at six myths that I believe are unnecessarily holding back innovation.
Myth #1: Devices are not secure and are vulnerable to malware.
Fact: Consumers use smartphones in countless secure transactions every day, in countries worldwide, from banking and online shopping to transportation. Remember: The first apps were introduced to the iPhone OS 2.0 back in 2008, more than 10 years ago. How many apps were you using in the last 10 years that had malware? With operating systems largely limited to iOS and Android, mobile devices are in fact highly robust, reliable, and secure. In the rare event something did happen, when data is sent to the cloud, the provider recognizes that elements and the schema have been manipulated.
Myth #2: Use of mobile devices is limited largely to a younger demographic.
Fact: The 55-and-over population actually represents the highest growth rate for mobile devices among all age groups today. In 2019, 8.2 million Americans age 55 and older will use a wearable device, up more than 15% over this year (cited by eMarketer, November 2018).
Myth #3: Mobile devices coupled with Bluetooth IoT devices can be used only for rudimentary data that is not relevant to clinical trials, such as vital signs like heartrate or rhythm.
Fact: The FDA supports the smart, secure, and safe interaction among different medical devices and information systems. Many people paid attention to the Apple Watch Series 4 implementation of electrocardiogram (ECG), but there have been several other examples of remote glucose monitoring devices, spirometry, blood phenylalanine, and dialysis devices used outside the clinic visit.
Myth #4: If we provision a single type of device to the patient, we control the screen size.
Fact: BYOD providers test out screen sizes used on a variety of standard smartphone and tablet devices. In the standard workplace, IT-department control of devices has largely gone away with the demise of BlackBerry. Patient scales such as the Visual Analog Scale (VAS) can be implemented in a variety of screen sizes that do not affect clinical data results.
Myth #5: Devices do not integrate seamlessly, do not have audit trails, and lose power quickly.
Fact: Service providers bring all device cloud data into 21CFR Part 11–compliant audit trails. Most devices do have the ability to repower and sync where they left off. BYOD providers typically can re-upload data when a patient hits a dead cell-phone zone. The majority of Bluetooth connections do work well, and providers have excellent help-desk supports in place to handle these rare occurrences.
Myth #6: Cool technologies like the collection of location data through BYOD pose HIPAA and privacy risks.
Fact: Consumer use of geolocation services through smartphones outside pharma is ubiquitous – from Google Maps to Starbucks, to wearable apps on Galaxy phones. Storing of personal data simply will not happen in the clinical trial, where purpose-built apps collect the data on a spontaneous, prescriptive basis for actionable insights, not for storage on cloud or repurposing. There are tremendous benefits for patients by leveraging phone geolocation including the following examples.
- Using environmental sensors, an automatic alert is sent to the participant in a smoking-cessation treatment to avoid an area known for air-quality issues or a high population of smokers.
- Notification is sent to the primary site when the participant visits an out-of-network emergency room not associated with the clinical study.
- Alzheimer’s patients and those suffering from dementia need to have the ability to alert caregivers when they have left a designated area, or a patient is showing decreased movement outside of the home – an indicator of advanced disease progression.
In 2019, Datacubed Health will begin to support several sponsors in moving their BYOD studies from either post-marketing research or small studies into large pivotal studies. The cost of drug development can start to moderate and decrease. Continuous data can then truly be leveraged to provide the entire 360 degrees of a patient’s real-life or real-world evidence, and not just a snapshot of a clinic office visit. Let’s rally around the change.
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