In this online exclusive, Mike Novotny, board member, founder and chief executive officer of Medrio, looks at the rise of real-world data as a result of patient centric approaches and movement towards precision medicine, and how new tech may help with collection and analysis.
digital data
The patient centricity and precision medicine movements have facilitated the rise of real-world data (RWD) and the expansion of clinical research, particularly in post-marketing or Phase IV studies, beyond the sites of randomised controlled trials. From improved patient recruitment to more nuanced insights and beyond, the potential benefits of RWD are many — and new technology, such as mHealth, wearables, and eSource, is making it easier than ever to collect and analyse it. But, even with circumstances aligning to unlock new possibilities in RWD, there are still barriers to be reckoned with. Technology needs to be integration- and offline-enabled. Study designs demand great flexibility. Just how much is really possible with RWD, and what challenges does it present to those looking to capitalise on its potential?
How real-world data can enhance patient interactions
The potential of RWD to ease recruitment woes is two-fold, encompassing both increased subject enrollment and retention. With RWD tools like disease registries, trial coordinators can find and contact potential subjects directly rather than hoping future clinic appointments lead to recruitment opportunities. This is a triumph for those who are homebound or do not make regular visits to their providers.
Considering some of the most common reasons for patient attrition include scheduling conflicts and site inconvenience, subject retention efforts would benefit from less-frequent and shorter visits. Using RWD — medical histories pulled from EHR, wearables providing biometric data, patient reported outcomes (ePRO) surveys in place of paper surveys — reduces visits to the most essential procedures. By capturing data before and throughout the trial and providing a better subject experience, trials could easily boost recruitment by incorporating real-world data.
Important considerations for a smart approach
With many new options available, understanding the strengths and limitations of RWD technologies is critical. Minimising the implementation burden should be a primary consideration. For example, would a home blood pressure monitor require training for both site staff and subjects? This may be more challenging to implement than, say, a wear-and-go activity monitor that passively collects data. Of course, cost is also a concern. For rare disease studies with limited populations, it is beneficial to invest in technologies that follow the subjects outside of the clinic. For large-scale post-market studies, RWD can still be captured efficiently with subjects’ own devices (a ‘BYOD’ approach). In any case, RWD should make research more efficient and cost-effective, not add new layers of challenges.
When considering devices themselves, usability, durability and connectivity are more crucial than feature depth. No matter who the end user is, he or she may have little experience with technology. An mHealth app could be a useful method to capture subject data, but it may cause additional difficulties for elderly or visually impaired subjects, for example. Capturing RWD means handling real-world conditions: for a wearable device, aspects like a tough, waterproof outer shell would help prevent device breakage that results in data loss. Also, consider that Internet connectivity is not guaranteed in the field. The best tools still capture data when offline and have a simple sync mechanism that sends the data right to the EDC system once reconnected. Many ePRO and eSource platforms are already taking an offline approach to support global health studies, and new products may follow the trend.
There is a wealth of data valuable to clinical research just beyond the walls of sites, and the rise of RWD shows its potential. With recruitment woes threatening trial survival, RWD serves a dual purpose of data capture and enrolment booster. Though RWD cannot fully replace clinic visits, RWD gives us the power to bring the trial to the patient and offers more options to fill in the blanks. Mass-deployment of tools like wearables and eSource is on the horizon, and proper selection criteria and user acceptance testing minimise barriers to adoption. Organisations should not delay in taking steps to ensure their preparedness to take advantage of these exciting shifts in the way clinical trials are conducted.