Igniting Patient Participation in Clinical Research Through Technology

Imagine being diagnosed with a life-threatening disease with few treatment options and no major medical center close to your home.

Amidst a dizzying array of thoughts, a friend mentions the possibility of participating in a clinical trial. But how to find one, let alone the right one? Your internet search uncovers some information, but it seems the closest trial is hundreds of miles away. Questions overwhelm you, with few answers and few places to turn: What will it be like to participate in a trial? If I qualify, how will I balance this with all my commitments at home?

Questions like these are common, and a lack of answers can translate into mixed emotions for many patients. Misinformation can also lead to difficulties for companies to recruit and retain participants. Patients often turn to their primary care and specialty doctors for information about participating in clinical trials. While the physician is trusted most, he or she may not have current information or the resources to help. Patients, with varying levels of health literacy, must then wade through a lot of disconnected and complex information.

If accepted into a trial, patients may have to travel long distances and adhere to rigorous study protocols — all while shouldering the burden of illness and the responsibilities of day-to-day life. Is it any wonder that approximately 3 percent of adult cancer patients participate in clinical trials, and that the dropout rate is sometimes more than 30 percent? When patients do not enroll or drop out, progress stalls and patients don’t benefit from new treatments.

The clinical trial ecosystem needs to coalesce around innovative technologies, a step that would ignite a culture of patient-centricity in clinical research. Allow us to take a glimpse into the near future to see how innovation could help patients.

The good news: There are many exciting changes on the horizon, with a wave of transformative technologies beginning to emerge that will disrupt the clinical research landscape.

Consider the well-documented challenges of connecting patients with suitable trials. Companies such as Deep 6 AI and IBM Watson are currently applying artificial intelligence to electronic health record data to help physicians find open trials for their patients. What might be possible in the next few years? What if shortly after diagnosis, and following the right privacy protections, you could be contacted proactively by groups running trials — making your search journey easier?

Technology can also make a difference by connecting patients virtually to trial sites via telemedicine, mobile and other digital health applications or innovations. Together, these technologies have the potential to make the process more inclusive and patient-centric.

For example, once deemed eligible and enrolled, the patient could learn more about the trial and sign informed consent documents from home and download a mobile app that explains the process and answers questions in easy-to-understand language, graphics or videos. One study found that participants who consented electronically retained information about the trial longer than those who consented by other means.

Taking the concept a step further, suppose you could enroll in a virtual, “siteless” clinical trial, where the investigators connect with you via videoconferencing at your home? This might provide more participation options for patients. Specialized companies that help conduct tech-enabled trials are proliferating (e.g. Medidata Solutions, Science 37, AiCure, Koneksa Health), and sponsors now have teams working to leverage innovations such as mobile apps in clinical research.

Patients will benefit from the ability to participate regardless of physical location, which in turn will increase not only convenience but satisfaction, connection to the research mission, and engagement. Companies, too, will benefit from more democratized participation — and thus, greater diversity in trial composition, as well as from lower dropout rates.

Technology has the potential to transform the clinical research experience for patients and improve outcomes, including increased recruitment and retention and faster development of therapeutics. But the clinical trial ecosystem can and should do more.

Barriers to development and adoption may include regulatory requirements, policies and organizational processes. Cross-sector collaboration could help enable the creation of an innovative ecosystem driving toward greater patient centricity by leveraging technology. The stakes are too high for business as usual. Patients are counting on us.


Colleen Rye, Ph.D., is a director at FasterCures, a center of the Milken Institute.

Diana E. Pankevich, Ph.D., is director of science policy and advocacy at Pfizer Inc.

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