Introduction

Strong patient engagement is the foundation of successful clinical trials, allowing study teams to deliver accurate data, adequate study power, and meaningful outcomes. Conversely, low engagement can undermine a study on multiple levels, impacting data quality, the detection of adverse events, and overall validity—not to mention timelines and study costs.

Sponsors have clear motives to maximize patient engagement, and the clinical research industry broadly agrees that reducing the participant burden is key to doing so.

However, despite efforts to lessen this burden by adopting patient-centric methods and digital tools—particularly in decentralized and hybrid studies—patient engagement remains a fundamental pain point in the clinical trials industry. Many studies that integrate patient-facing technology still grapple with low compliance and retention, and too many fail due to low accrual and enrollment.

In Contemporary Clinical Trials Communications, researchers note that underpowered trials can be unethical when participants don’t know that their results are unlikely to contribute to a statistically significant outcome. They conclude that “poor recruitment, enrollment, and retention remains a primary area of concern” for clinical research.

So, with stakes high and actions taken to innovate and improve, why hasn’t the clinical trials industry solved the challenge of patient engagement?
‍

Why Existing Patient Engagement Models Fall Short

Simply put: Existing models for tech integration don’t align with actual patient behaviors or the underlying factors that motivate patients to complete a study. Technology integrations that focus primarily on the needs of study teams rather than patients will, by definition, lack patient centricity.

These shortcomings are evident even when trials leverage a “bring your own device” (BYOD) model, in which patients complete study tasks on their own mobile devices. The presence of familiar technology doesn’t guarantee that a study is designed with the patient in mind.

In addition, study designs too often fail to incorporate adequate patient support. Patients with questions, concerns, or any other issues want immediate access to trial staff. Technology can provide convenient outlets for patients to communicate with study teams through text, email, or video calls; however, these channels are often too difficult to access when the patients need them, or the staff who respond are not knowledgeable about the specific trial.
‍

A Comprehensive Approach to Patient Engagement

To tackle these challenges, the industry must recognize that no single technology will increase patient engagement across the board.

Instead, patients need a comprehensive patient engagement strategy that combines behavioral science, intuitive technology, and streamlined patient support. This strategy should integrate with human behaviors and seamlessly guide participants through each stage of the clinical trial process.

This approach to tech integration in clinical trials drives patient engagement in three important ways:

Motivating Patients to Engage with a Clinical Trial: The 4 Cs

Before we explore why people engage in a study, we’ll define engagement as participation in the study tasks until the trial is complete. The type, volume, and duration of these tasks vary based on the therapeutic area, intervention being tested, desired endpoints, study timeframe, and other factors. However, every trial requires a baseline of patient engagement to achieve accurate endpoints and validity. We can summarize these expectations for participants as the “four Cs”:

The last area is a particularly persistent challenge for study teams. Most patients who start studies intend to participate fully. But, even for the most dedicated patients, completing a study requires them to exercise willpower, which can diminish over time (before a trial concludes).

The simple explanation for waning participation is that busy patients are distracted from trial tasks by other responsibilities. Moreover, their needs vary—individually and across populations. For instance, participants who are balancing careers and parenting have different time constraints than retirees; patients who have mobility issues, live far from sites, or have limited access to transportation will be more likely to lapse if frequent visits are required.

In fact, the patient’s surrounding environment—both physical and virtual—can play a key role in their level of study engagement. In their work on change management, authors Chip and Dan Heath state, “What looks like a people problem is often a situation problem”; they demonstrate that making a situation easier makes change more likely.

For these reasons, study teams should:

• Understand the contextual and situational factors that may influence how participants experience the trial and that could become barriers to compliance and retention.
• Develop a study design that minimizes difficult situational factors and introduces motivational tools to overcome them.
• Support patients with intuitive technology and streamlined access to a site team.

In addition to contextual factors, it is important for sponsors and study teams to consider the drivers that motivate patients to engage in clinical trials and to seek to align these with the trial design. An effective patient engagement platform should leverage several intrinsic and extrinsic motivators to make study tasks easier and more enjoyable for participants. These motivators activate the brain’s natural reward pathways to encourage participants to stay the course throughout the study.
‍

Gamification

Gamification applies elements of game playing—such as point-scoring, competition, and rules of play—to foster engagement with another activity. The consumer ecosystem is replete with examples of gamification, from fitness challenges to language learning rewards on apps.

In clinical trials, gamification offers patients a sense that they are controlling their own destiny within the study while also prompting them to complete their assigned tasks. Examples of gamification in clinical trials include:

‍

Compensation

Remuneration is a tangible incentive to drive participation, even for patients whose primary motivation is to advance science. One study found financial gain and finding a therapeutic alternative were the two most common motivators for participants.

A patient engagement platform should leverage this motivator by incorporating:

‍

Altruism

Altruism taps into the human desire to feel like, or be seen by others as, a “good person.” Research published in Neuron found positive social feedback is represented in the same brain regions as monetary rewards. 

A patient engagement platform can affirm the generosity of participants as they proceed through the study tasks. This “feel good” emotion may in turn create a halo effect around the study.

Altruism-based motivation can look like:

‍

Health improvement

Some patients may be inspired to complete a trial if they know they’ll be able to access the health data collected during the study, particularly if they have rare or understudied diseases. While sharing data with patients is not possible for certain protocols, this motivator can be appropriate for some studies when shared at the close of the clinical trial or when it is determined that the information will not significantly bias outcomes.
‍

Removing Friction with Intuitive, User-Centered Technology

Mobile user experience has advanced significantly in many industries, but patient-facing healthcare technology has lagged by comparison. A prime example: Many clinical trials still require participants to report their outcomes on provisioned devices, although research suggests that a BYOD approach is more effective.

Researchers note in Digital Biomarkers that “[t]he benefits of BYOD studies are multifarious,” including:

• Greater compliance resulting from participants using their own devices.
• The ability to design patient-centric studies with lower costs and burden on study sites.
• Expanded access for populations with limited access to clinical facilities (e.g. older adults, people with disabilities, or those living in remote locations).

Incorporating a BYOD model is just one facet of improving the patient experience. Another is ensuring that user interfaces are simple, seamless, and intuitive. In order to accomplish this, all patient-facing modules should be integrated into a single study app.

‍

‍

Electronic consent (eConsent)

eConsent offers participants the time to review information at their own pace, with a series of screens that explain the parameters of the study. eConsent can also incorporate comprehension quizzes and real-time access to a virtual clinical study team to resolve questions.

‍

‍

Training

Multi-media, on-demand access to educational materials can increase understanding of critical study elements, driving adherence and participation.

‍

‍

‍

Electronic patient-reported outcomes (ePRO)

Electronic diaries, questionnaires, and other study tasks allow patients to capture and report relevant data in real time.

‍

‍

‍

Electronic performance outcomes (ePerfO)

Performance outcomes can, in certain studies, be completed via remote instruction and captured using digital or medical devices. The data can then be centrally scored by clinicians.  

‍

‍

‍

‍

Augmented ePRO

Rather than having participants enter their data, augmented ePRO leverages machine learning and “smart capture” to guide participants in the submission of higher-quality unstructured image, audio, and video data.

‍

‍

‍

Combining these patient-facing modules and functionalities into a single BYOD platform results in an effective user interface with one consistent, predictable, streamlined user flow. But, to elicit the greatest effect, every touchpoint within that flow must also be optimized for human behavior—using design psychology principles.

For instance, according to the principle of least effort, people seek out the simplest ways to complete tasks. With that in mind, clinical trial apps can incorporate one-finger gestures, such as button push and scrolling, that mimic the ease of thumbing through a social media app.

For tasks that require sustained focus and concentration, patients need to understand where they are in the process. In-app visual cues like timelines illustrate which step they’re currently on and how many steps are left.

These are just two examples of how clinical trial app designers create intuitive user interfaces. While these details may seem small, they’re key to designing products around patients’ needs.
‍

Combining Digital Tools with Human Support

Intuitive technology alone is not enough to foster strong patient engagement. Participants need the human element, too. Even in the most tech-enabled study, patients expect a connection with clinical research staff.

Writing in Contemporary Clinical Trials Communications, researchers propose several guidelines for improving the success rate of clinical trials. They note that “[a] key item deserving more attention is the minimization of patient burden and maximizing patient appreciation.”

The authors suggest that study teams can improve patient engagement by “understanding what the patient's day-to-day experience during the trial is likely to be.”

A virtual site team should understand the study design of the specific trial and the burdens participants within a specific therapeutic area may face. This type of knowledge can create a trusted relationship with participants.

An accessible, responsive virtual site team also reassures patients that their health concerns are valid and worthy of consideration. Sending this message encourages a virtuous cycle of engagement throughout the study.

Technology can enable study coordinators to provide better support to patients. For example, patients and study teams can communicate via text messages on an ongoing basis, if needed. All communication can be time and date stamped for auditing purposes. In addition, study coordinators can utilize real-time dashboards to monitor for compliance and safety. This allows for the near-immediate detection of possible adverse events so the study team can intervene and provide better care.
‍

The Benefits of Patient Engagement in Action

The benefits of a tech-enabled, human-supported patient engagement strategy are clear. More motivated and supported patients—empowered by an intuitive, easy user experience—deliver better, more accurate data for sponsors.

Renovia, Inc. saw these advantages in the first fully virtual study conducted in the urogynecology space. Patients used a study app that allowed them to record bladder leaks and bathroom visits in real time with the tap of a button, increasing the accuracy of the data and reducing recall bias. The app also prompted patients to report changes in health status to help the clinician team promptly identify adverse events. 

Meanwhile, a virtual site team supported patients via live chat in the study app to monitor adherence, answer questions, and offer tech support. As a testament to its strong patient engagement strategy, the study delivered statistically significant results:

‍

‍

A study for a COVID-19 treatment saw similar success leveraging digital tools in combination with a tech-powered virtual site team. Because the patients in this study were experiencing symptoms associated with coronavirus, the sponsor—RedHill Biopharma—sought to reduce participant burden as much as possible: Wearables for vitals measurement, home health visits, and BYOD ePRO were all incorporated into the study design to streamline engagement and mitigate barriers to compliance, such as travelling while symptomatic or cumbersome data reporting processes.

Data collected via ePRO and wearables was automatically transferred to a DCT platform where it was closely monitored by the virtual site team for any irregularities or possible adverse events. The team was also available to provide support to patients via phone, text, or email whenever needed.

This combination of technology, team, and patient-centric design not only facilitated a 100% reduction in hospitalizations due to COVID-19 but also stronger engagement, which produced the data needed to initiate discussions with regulators.

‍

‍

Bringing It All Together

Technology alone is not enough to achieve the levels of patient engagement required to ensure data quality and high completion rates. An effective patient engagement platform must balance behavioral science, intuitive technology, and streamlined patient support.

These features allow study teams to remove friction, integrate into real-life behaviors, and guide participants throughout each stage of the process—motivating them to engage over time while also empowering them to deliver stronger evidence to support trial endpoints.