Improving patient compliance is one of the greatest challenges faced by clinical researchers today. And with spending per patient in pivotal clinical trials now averaging over $41,000¹, the pressure to keep patients compliant and retained is enormous. Additionally, in light of the COVID-19 pandemic, IRBs have imposed limits on in-person visits, leading many study teams to virtualize aspects of their studies. This is a big concern. Researchers rely on these face-to-face visits as critical touchpoints to encourage patient compliance. Consequently, study teams must develop workflows and strategies to ensure patients stay compliant in today’s virtualized trial environment.
Tools For Improving Patient Compliance
At the heart of any virtual trial are the tools used to enable remote research. These technologies empower sites to keep connected with patients and their study-related activities.
Activity dashboards can be a powerful way to enable sites. By showing which patients have completed various instruments, sites can track tasks and ensure activities don’t slip through the cracks. If a patient misses an activity, such as completing an ePRO, sites are then able to proactively reach out to patients and address compliance issues before they compound.
Messaging and Announcements
Sites and patients need ways to quickly and effectively communicate with one another. Consider using a study app that allow for study announcements and direct messaging. This is especially useful when it is built into the site’s compliance dashboard, making it easy for staff to identify and connect with unengaged study patients.
Work to find solutions that allow patients to complete their virtual visits in the same tool they use for other study-related activities. By eliminating the need for multiple apps, study teams eliminate complexity from study participation.
ePRO and eCOA
While perhaps the most ubiquitous virtual study tool, the role of an easy to use eCOA or ePRO should not be understated. Patients are busy, and as consumers, they have a low tolerance for poorly designed software. Consider the use of an ePRO that’s available via a mobile app and features a consumer-friendly user interface.
Sites Have a Big Role to Play
Sites have a large role to play in promoting patient compliance in virtual trials. Patients should always know who (and how) to reach out to should they have a question about their medication or study activities. As patients perform tasks like eConsent, consider setting up a telehealth session. This gives patients the opportunity to ask questions about the study as they review the consent materials, and builds a relationship with site staff. These study onboarding calls are also a great time to review information on how to complete ePRO or eDiary instruments. During the course of the study, ensure its easy for patients to ask questions, and receive a timely response from their site.
Apps that use behavioral science strategies like avatars, maps, and digital gems may help improve compliance in clinical trials.
Behavioral Science Can Help
Another way to help promote compliance in clinical trials is to leverage engagement strategies from behavioral science research. Research shows the number one reason patients join studies is to help those dealing with their disease². Fostering that positive self-identification can have a major impact on compliance and retention. Apps that use avatars as part of the trial experience may help create that sense of identity, boosting patient compliance, and retention rates. Using informational resources for patients, visual study overviews, and digital rewards can also help increase compliance and retention rates.
Indication and Population Matter
Patient population and treatment indication can impact the likelihood that a trial will face challenges with low compliance.
- Population – Will your clinical trial enroll children or the elderly?
- Indication – Is the treatment indicated for a population with known compliance issues? (e.g. cognitive impairment, substance use disorders)
What’s important in any study is to work with patient advocacy groups to understand the needs of a specific population. When working with older adults for example, including larger images with instructions on completing instruments may be needed. When working with a population with children or adults with cognitive impairment, consider including resources for caregiver support.
To Sum it Up
While compliance has always been a concern of study teams, virtualizing clinical trials in light of the COVID-19 has brought it to center stage. Setting up your study with the right tools, including a compliance dashboard, messaging, virtual visits, and eCOA, can make all the difference. The role of sites becomes even more important during virtual trials, where they must help different patient populations complete activities remotely. Lastly, consider your patient population and how their needs may impact your virtual study.
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- “Research, Methods, Statistics | JAMA Internal Medicine.” 24 Sep. 2018, https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2702287. Accessed 6 Jul. 2020.
- “Global Public Attitudes About Clinical Research and Patient ….” 5 Oct. 2018, https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2705849. Accessed 7 Jul. 2020.