This article was originally published on April, 20, 2016 as a part of the Partnerships in Clinical Trials Blog.
With the development of exciting new digital technologies, the clinical research industry now has the tools to make clinical trials more patient-centric than ever before. In particular, the emergence of wearable and mobile health technologies have the potential to greatly advance patient-centricity in clinical trials through real-time data collection and participant engagement.
However, it’s important to make objective decisions about the use of mobile technology to maintain a truly patient-centric trial design. As exciting as mobile health is, some technologies may impede the patient-centricity of a trial, making participation more difficult for some individuals.
How mobile health technology could revolutionize patient-centricity in clinical trials.
One of the most exciting capabilities of mobile health technology is the real-time data collection feature of some wearable devices and mobile apps. These features make data collection of everyday activities, such as exercise and sleep habits, more continuous and likely more accurate. Mobile apps allow participants to complete surveys in real-time, reducing recall bias. Patients can also self-track health-related items like blood pressure, diet, and more using commercial wearables or FDA-approved medical devices.
These mobile health capabilities could ultimately lead to a decrease in clinic visits or follow-up phone calls for participants, making it easier and more cost effective for people to participate in a clinical trial. It could also increase the scope of a trial by allowing individuals to participate from a greater distance, as travel requirements are reduced. This can lead to a more representative population by making it easier for people from rural areas to be involved in a study.
Participant engagement could also increase through the use of these technologies, as it’s now easier to communicate information and transmit surveys and other trial-related activities. If a participant has a trial-related question, it’s possible for her to check the mobile app and have the answer at her fingertips when needed, either through communication with study staff or in mobile documentation. A survey or activity could be transmitted and completed in real-time using the mobile health app, requiring little effort on the part of the participant. The participant can be continuously engaged with the study and provided the necessary information, making trial participation convenient and potentially more enjoyable.
Why mobile health should not be used for every clinical trial.
As described above, mobile health has a lot of potential in the clinical research space and could make the clinical trial experience much more patient-centric. However, these technologies may not be appropriate tools for every trial. It’s essential to be sure you’re using tools that enhance the patient experience and ensure data integrity. For some patient populations, mobile health could prove detrimental. When determining whether mobile health is appropriate for your clinical trial, evaluate and characterize your participant population and their relationship with digital technology. Also take into account the feasibility of a mobile health study and assess whether you have the necessary resources to provide the best participant experience. Answer these key questions when considering mobile health for your study:
What is the age range of my participant population?
While younger generations are very adept with technology, seniors may struggle to use mobile health applications or devices. Using mobile health for an older demographic may require research staff to provide extra training. Such trial design could also inconvenience an older patient population as it may require them to perform atypical tasks and significantly alter the way they function throughout the day.
Do the majority of my participants have smartphones?
The demographics of your participant population, including age, financial status, location, as well as a variety of other factors, could influence whether they have access to a smartphone. If some of your participants don’t have smartphones, will you provide them the necessary technology? This could prove logistically difficult and limit the amount of eligible study participants in your target population.
Will my study use apps that participants already use? (e.g. Fitbit, MapMyRun, MyFitnessPal, other diary applications)
If your study requires you to create a new app, it could be difficult to find the resources and expertise to properly develop this technology. It may also require extra effort to encourage study participants to use the new application. Employing an application that is already widely used could reduce the amount of change required in a participant’s daily behavior, making the trial more convenient.
Is real-time data truly necessary for the benefit of my study?
The potential of mobile health and real-time data is exciting and it’s tempting to take advantage of the technology regardless of whether your study will truly benefit from its use. Critically evaluate whether the costs of using mobile health (such as those listed above) are worth the benefits of real-time data. If the benefits fall short, it may be best to opt-out of mobile health and design a trial better suited to the needs of your study and participants.
While mobile health technology could revolutionize how the clinical research industry conducts clinical trials, patient-centricity relies on the industry’s focus on building a positive participant experience. Regardless of whether mobile health is incorporated into study design, it’s essential to design each trial with the participant’s best interests in mind.
Learn more about how to determine the demographics of your participant population and use the appropriate engagement methods by reading our free eBook, “Patient Recruitment in Clinical Trials: Steps to Develop a Successful Enrollment Strategy.“