Digital Health Technology May Increase Access to Clinical Trials

Frequently cited obstacles to participation in clinical trials include transport and travel difficulties; difficulty coordinating with work schedules and other commitments; loss of income; and childcare/family responsibilities. Decentralized clinical trials, which often rely on digital technology, can reduce or eliminate the need for participants to travel to specific study sites; this helps address many of these obstacles and makes it possible for more people, and potentially more diversity of people, to participate. Digital health technology such as electronic consent, telehealth, and remote monitoring, can help to support these remote research efforts.

“Many clinical trials fail to meet their enrollment targets and therefore do not measure the endpoints that are of most interest,” said Kenneth Mandl, MD, PhD, director of the Computational Health Informatics Program (CHIP) at Boston Children's Hospital and a professor at Harvard Medical School. “There are increasingly new opportunities to improve the way we match people for trials and collect real world data.”
 

Reducing Travel and In-Person Requirements

Several digital possibilities may be useful to eliminate the need for in-person visits without loss of information essential to the study:

• Remote mobile tools and sensors to measure physiological parameters like heart rate, seizure activity, or exercise tolerance
• Video visits instead of in-person evaluations
• Hybrid data collection approaches in which trial participants use app-based instructions and directions matching them to clinical trials and submitting samples by courier.
• Connecting electronic health records (EHRs) to apps to enable clinicians to monitor participants and manage and visualize their data.
   

Leverage the Electronic Health Record

The 21st Century Cures Act mandates that everyone have immediate electronic access to their health information, including test results, medication lists, and clinical notes. This has the potential to make it easier to find and participate in a clinical trial by allowing a trial participant to connect an app of their choice and consent to providing access to their health systems’ EHR.

The most prevalent example of this approach is the Apple Health app, which connects to more than 800 health systems. “It enables 200 million people in the country today to get a copy of their electronic health record data in the health app on a smartphone,” Mandl said. “That data is in a computable format so one could imagine with this kind of capability, a very robust way to match the criteria for the trial to an individual’s medical record, and this would be particularly useful for people who are looking for a trial and increasing access to trials for more people.”

Digital tools should allow for decreased costs because of less staff time needed for patient visits. This may be offset, at least initially, by startup costs to develop new tools and metrics, validate them, creating the infrastructure to deploy them, and staff training time.
 

Digital Tools May Also Help Increase Trial Diversity

The NIH-backed All of Us program aims to collect data on one million people in the United States for the purpose of improving biomedical research by intentionally including people that have been underrepresented in the past. Currently, 500,000 people have enrolled. According to data available on their website, of the more than 350,000 participants who have completed the initial steps of the program, more than 50% represent racial and ethnic minorities; of these, more than 80% represent racial and ethnic minorities that are underrepresented in biomedical research. Study participants also include sexual and gender minorities, people with low income, and people with limited education.

All of Us relies on several techniques to broaden their program’s inclusivity:

• Traditional digital tools like email
• Computer-Aided Telephone Interviewing (CATI) for survey collection, involving telephone interviewing guided by computers (particularly for non-English speaking individuals)
• Electronic consent supported by live translators
• Loaning of electronic tools, including laptops and tablets

“Getting equitable outcomes depends on better representation in all parts of the research process,” said Chris Lunt, chief technology officer at All of Us. “And that means collecting data in a way that is respectful of the preferences of individuals and their communities.”

The program’s data collection process can be a model for increasing inclusion in clinical trials.
 

Deploy Digital Technology Thoughtfully and Equitably to Avoid Creating New Obstacles

While technology can remove some of the barriers to study participation, it can also create new obstacles to diverse enrollment. For example, wearables like Fitbit and Apple watches are financially out of reach for many, and clinical trials that rely on technology do not always provide that technology to study participants. In addition, wearables may not provide reliable information for people with non-white skin tones. And some of the same communities that are underrepresented in clinical trials are also the ones who have a harder time participating when the experience is fully digital.

“It is really important that we recognize that digital tools are not a silver bullet,” said Jennifer Goldsack, CEO of the Digital Medicine Society. “It’s all about how we deploy them to do the most good for as many people as possible instead of continuing to do the same kind of trials that are inaccessible to the majority of potential participants. It’s less about whether to use a digital tool to improve access to clinical trials; it's more about how.”

Lunt agreed, adding, “To really include everyone in a study, you have to be aware of the benefits — and limits — of digital products. You need to have diversity from the very beginning, including the processes for developing and using technology that will help you get results that apply to everybody.”