Enabling Digital Clinical Trials

Jonathan Palmer
Senior Director, Product Strategy

Patient recruitment remains one of the top reasons for delaying, or even cancelling, a trial before it begins. In many cases, the barrier to achieving recruitment targets is not that there are insufficient patients to meet the protocol inclusion criteria, but merely because of their location(s) in relation to the investigator site(s). Large and scattered patient populations for a given trial are often outside of a reasonable commuting distance from a site; hence, they never volunteer.

Those same patients have a smartphone, a food diary app, a running tracking app, a Fitbit, Alexa, and more. They may also be diabetic. And, instead of pricking themselves multiple times per day to measure blood sugar, they are rejoicing at having just received a continuous glucose monitor which helps manage their condition 24x7.

When the industry combines these two macro dynamics, it’s clear that there is a clinical trial world eager for 21st century-ization. No subject wants to visit a clinical site in downtown Chicago on a Friday afternoon in rush hour to have his/her blood pressure checked after searching for a parking space for 30 minutes. Then, no subject wants to be told that his/her eczema rash “looks much better than last time,” when the day before, it was flaming red and the worst it has ever been (but now is invisible to the Investigator).

The concept of patient centricity is rapidly changing from a concept invented by the life sciences industry to a necessity driven by subject demand. If the industry does not make life easier for prospective subjects, and does not enable them with the sensor/wearables/app experiences that are available in their consumer lives, then our potential patient recruitment challenges will become even greater.

Introducing Oracle mHealth

At Oracle Health Sciences, our vision is that every trial should be able to embrace new data sources and patient engagement tools quickly and easily, as is appropriate for each trial. Our goal is to simplify adoption of new technologies. For clinical program managers, protocol designers, and therapeutic leads, our concept is to simplify choosing the right wearable/sensor/app/ source(s) that make sense for their trials and rapidly move into patient recruitment mode.

The Oracle mHealth platform easily allows a wide variety of data sources to be connected into a clinical trial ecosystem. Once the data is acquired, it can be monitored, aggregated, and distributed to downstream clinical systems for review and analysis. This single platform reduces the number of technical integration points, optimizes third-party vendor interactions, and simplifies the way clinical trial teams can embrace new methods as part of a digital trial program.

The platform supports a wide cross-section of sources ranging from simple medical devices, such as Bluetooth blood pressure cuffs, to consumer devices, such as activity trackers, to advanced cloud-based device vendor solutions, to mobile app integrations, and to electronic health record (EHR) integrations via Fast Healthcare Interoperability Resources (FHIR). Data flows through the platform and is subsequently presented to the end user -- whether that is the subject, site, or an internal team or teams -- via the appropriate app for their use case.

We at Oracle Heath Sciences are very excited about this new platform, and the opportunity it provides for the industry to embrace remote patient monitoring and virtual trial methodologies at scale across all clinical trials. We look forward to sharing more of our vision for digital trials with you.

For more details see:

Oracle mHealth Datasheet

Applied Clinical Trials: The Future of Mobility and Medicine

Interested in learning more? Contact us for a conversation.




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