Technological advancements are driving one of the most significant clinical trial transformations to date. Data collection, once exclusively clinic-based, is moving more and more into study participants’ daily lives. Thanks to sensors, apps, and other digital health technologies, it is increasingly feasible and cost-effective to engage with patients directly. This shift provides study sponsors with more representative insights about study participants’ responses to treatment. It also reduces the stress associated with repeated clinic visits and increases the accessibility of clinical trial participation.
While home-based data collection is not a new concept, a perfect storm of industry catalysts has accelerated this paradigm shift in recent years. A great example of this transformation is glucose monitoring. Originally, this technology began as a rare and expensive test administered in hospital settings. As technology evolved and home-based testers became available, patients began to track their data daily basis, albeit in paper diaries. Now, app-based blood glucose tracking and continuous glucose monitoring technologies enable timely data transfer in an affordable, scalable, user-friendly way. Today, ambulatory monitoring of data such as glucose levels, cardiac function, and blood pressure is not only accepted, but often required by regulators in select indications.
However, patients’ expectations for clinical trial connected devices are inevitably affected by the growing digital health industry. While this movement started in the realm of fitness and wellness, many large players are moving into medical settings: creating electronic health record portals, developing medical grade sensors, and operating application marketplaces for health-conscious consumers. Many of the most successful companies driving this digital health transformation were born digital, with precision focus on customer experience. These companies know that patient experience drives the adoption of their technology and the viability of their business. Now more than ever, patients are informed consumers of their own health care and they increasingly demand the seamless user experiences, quality products, and timely support provided by other digital technologies.
In clinical trials, user experience affects patients’ and sites’ willingness and enthusiasm to engage with connected devices. These experiences have downstream effects on adherence, study operations, and data quality. It is essential that sponsors and other stakeholders approach connected devices through a user experience lens during study design. The use of connected devices in clinical trial settings poses several unique challenges which do not apply to consumer devices. Regardless, consideration of user experience is key to overcoming these challenges.
Clinical trial connected devices must be accessible to patients with diverse health statuses, digital literacy, languages, and culture. To ensure the validity of the data these devices provide, clinical trial connected devices must be used in a controlled manner in many cultures, languages, and patient populations with varying digital literacy. Considering diverse user experiences during device selection and throughout the design of training and support programs is critical to prevent misunderstandings, misuse, or inconsistent use of connected devices.
In many cases, the successful use of connected devices depends on patients’ willingness to engage with the devices regularly and independently in their daily lives. This engagement could include wearing devices according to the protocol or transmitting data to the study’s systems. Ultimately, the data generated by these devices is only as good as the study participant’s compliance to the study protocol. A participant’s experience of the device – positive or negative – will affect their engagement with the technology, and ultimately may have implications for the quality and completeness of study data.
Medical and research-grade connected devices are highly regulated, subject to tight change controls, and must be used consistently throughout a trial to be considered valid. Realistically, it is not always possible to achieve consumer-grade user interfaces with medical and clinical trial technology. However, it is important to note that ease of use is not the same thing as user experience. While ease of use depends on the function and design of a technology, we have other tools in our belts to improve the user experience of a technology. Patient satisfaction with clinical trial technologies is linked to perceived importance and accuracy of the technology, study site endorsement, and the support they receive when something goes wrong. In short, communication and support are key. Even when we cannot alter the technology itself, we can improve user experience by communicating the benefits and rationale for using a specific technology. Perceived value and accuracy of a technology factor strongly into patient satisfaction and affect their willingness to engage with digital health technology over time. Effective training, and subsequent support will also affect patients’ expectations, satisfaction, and engagement with a connected device.
Finally, the connected devices space is rapidly increasing in complexity and heterogeneity as clinical trials become less centralized. Individual technologies are becoming increasingly complex, and neither study staff nor participants are technical experts. On top of that, the number of technologies and endpoints are being used in clinical trials is growing, requiring users to learn more methods and use more interfaces. As this industry scales, we will need to provide solutions which can provide sites, patients, and sponsors with the skills and support they need to run clinical trials.
Large patient facing guides and investigator manuals are increasingly necessary, however they are no longer sufficient to meet the training needs of study sites. Besides creating more intuitive user interfaces through well-established human centered product design techniques, innovative training approaches like virtual simulations or video trainings can fill current gaps. Sites must also be equipped to train and support study participants. Technical issues place burden on sites as a first line of support to patients. The help desk and customer care experience therefore plays an important role when using connected devices. As opposed to most other domains, these help desks need deal with unprecedented interdisciplinary coverage: issues can be related to software, hardware, user error, or medical, with potential impacts on clinical safety and data quality.
On the operational side, connected devices pose unprecedented challenges related to data management, logistics, and inventory management. Data managers and sites must ensure data quality despite the potential for technical issues, user error, patient nonadherence, and large data volume. Traditional data management teams are not accustomed to these challenges: it requires specialists. The use of connected devices also increases the number of devices and disposables which sites must manage during a trial. Poor user experience during any of these processes may affect sites’ willingness to engage in connected device trials in the future.
Managing these complexities is becoming one of the most important competitive differentiators for Clinical Research Organizations (CROs). CROs can accommodate this heterogeneity through economies of scale, learn from and apply diverse experiences, enable better and more harmonious user experience at a faster pace. Customizing device offerings, trainings, and support packages to individual studies quickly with reasonably low overhead is something that only the largest CROs can manage at scale.