Patient engagement in clinical trials can make or break a study. Engaged patients are more likely to participate and complete studies, which can strengthen data collection and, ultimately, provide more robust therapeutic evidence of safety and efficacy.  

In recent years, decentralized clinical trials (DCTs) have emerged—and been promoted—as solutions for driving effective patient engagement. But, while the design of a DCT can reduce burden for patients, decentralization doesn’t inherently increase patient engagement on its own. Instead, it’s the combination of DCT technology and team that is key to unlocking meaningful interactions with trial participants and motivating them to complete a study.

In this article, we examine the “tech and team” approach to patient engagement and demonstrate how it can support:  

• More efficient and impactful clinical trials.
• Optimal patient enrollment.  
• Sustained compliance with study protocols.
• Stronger evidence.  

But, first let’s explore clinical trial patient engagement in context.
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History of Patient Engagement in Clinical Trials

The relationship between patient engagement and the industry’s more contemporary definition of “successful” clinical trials can be traced back to the HIV/AIDS epidemic in the late 1980s. During this period, patient advocacy groups protested participants’ lack of involvement in drug development processes, demanding a seat at the table. “We are the people who are experiencing this novel disease,” one protester asserted, “and we are the experts, not just the scientists and doctors.” Activists pushed for better access to potentially life-saving clinical trials, calling for the research to be conducted in communities hit hardest by the disease—where doctors familiar with the patients could take part in their treatment and care.  

In response to this grassroots activism, access to clinical trials for HIV/AIDs was expanded. Many study protocols called for the inclusion of illegal drug users, women of color, and children. In addition, the NIH included patient advocates on drug testing committees, and the FDA created an office to work with patient advocates on regulatory reform. This was a turning point for medical research.

Today, another revolution—the digital revolution—is transforming healthcare and clinical research. And, once again, patient engagement is evolving.  
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Technology can maximize participation … but only when a team uses it effectively.

The emergence of mobile applications, wearables, and artificial intelligence has led to the proliferation of decentralized clinical trials—also referred to as tech-enabled clinical trials. Approximately 77 percent of studies in 2022 included at least one decentralized component.  

These new methods are enabling sponsors to leverage technology for better patient engagement. In fact, research indicates that trial designs with “convenience measures” such as user-centric technology correlate with high overall participant satisfaction.  

However, despite the convenience they introduce, decentralized components don’t automatically equate to more successful patient engagement or stronger evidence. These tools are just one half of a comprehensive patient engagement strategy that requires both tech and team.  

What the team provides is the human element of the patient experience—a connection to the study that even the most advanced technology can’t replicate. “Team” in this context refers to not only the study teams who work with participants to develop more patient-centric study designs but also virtual site teams, who provide on-demand support to patients while monitoring their safety and compliance. Like patients, these teams are augmented by technology.

This combination of human connection and digital tools creates a reciprocal relationship between tech, team, and participants that facilitates a stronger commitment to the study and, as a result, better patient engagement.    
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Strategies for Engaging Patients Throughout the Clinical Trial Journey

A tech-and-team approach can be integrated into all steps of the clinical trial process to support optimal patient engagement—but particularly:

• Study design and setup.
• Study app design and experience.
• Enrollment and onboarding.
• Intuitive outcomes measurement.
• Remote patient monitoring.
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Study Design and Setup

One practical way to increase patient engagement in clinical trial development is to incorporate the guidance of patient advisors. Study teams can leverage the insights shared to improve any stage of a research project—especially study design.  

By collaborating with patient partners from the start, researchers gain a deeper understanding of patients’ lived experiences and unique perspectives. This information can help study teams and sponsors to build a more impactful clinical trial—one that’s more meaningful to patients and that better represents the real-world practicality and efficacy of the treatment under study.  

Including patient input as part of the clinical trial design process can help study teams:  

• Improve the study framework.
• Pinpoint and address ethical implications that affect patients.
• Identify relevant endpoints and outcomes not initially evident to sponsors.  
• Support better data collection, improving applicability and efficacy.  
• Choose patient-friendly data collection tools, such as digital instruments and electronic patient-reported outcomes (ePRO).  
• Determine the frequency of outcome reporting and the feasibility of on-site appointments, home visits, and/or virtual consultations.
• Understand the level and type of support needed from a virtual site team.

The advantages of “co-design” with patient advisors are tangible: stronger evidence. When research feels relevant to patients, they are more likely to enroll, engage, comply, and complete. And, when chosen endpoints reflect therapeutic improvements that actually matter to patients, the probability that the intervention is successfully implemented into clinical care increases.  
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Study App Design and Experience

Understanding patients’ experiences, in combination with behavioral science, also allows researchers to better design a study app experience that motivates participants to engage.  

In decentralized trials, bring-you-own-device (BYOD) mobile apps often accompany participants throughout the study. With the proliferation of smartphones, scrolling an app has become second nature to many, and healthcare apps should be no different. Trial apps can be designed to streamline engagement with features such as journey bars, one-finger selection, and easily legible text. In addition, they can include motivating features that encourage patients to comply and complete, including:  

• Gamification: An app can tap into the competitive spirit of many by including patient performance indicators and fostering engagement through celebratory messages and regular encouragement.
• Compensation Incentives: At-a-glance screens can display stats for total payments received versus projected payments. Compensation is interspersed throughout the trial, motivating patients to work toward the next payment milestone.  
• Altruistic Messaging: Patients are reminded of the value of their participation through messages that reinforce the impact of their involvement.
• Health Improvement Data: Study protocol permitting, patients can have access to certain health indicators, like personal health metrics and overall progress.
• New Task Notifications and Reminders: Patients are alerted to new tasks and reminders via push notifications to increase study compliance, adherence, and likelihood of study completion.

Rooted in behavioral science, these motivating features can help to make clinical trial participation more entertaining and engaging. But, study teams cannot discount the importance of pairing motivation with support. A study app should also include features that make virtual site team or clinician accessibility seamless for patients.  

For example, a BYOD app can help to facilitate the human connection patients need through the integration of in-app text messaging or chat functionalities. These features close the gap between trial participants and virtual site team members—with positive outcomes: A recent observational study of 295 patients who received text messaging about their healthcare found that 98 percent of patients appreciated receiving the text messages, and 96 percent said they felt more connected to their care team as a result.
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Enrollment and Onboarding

According to the CDC, there is “a growing body of evidence that shows people with higher patient activation (i.e., the knowledge, skills, and confidence to become actively engaged in their health care) have better health outcomes.” This is especially relevant to the clinical trial enrollment and onboarding period—a critical, yet delicate, point in the trial process when researchers must provide patients with the health literacy required to be a successful trial participant.  

If participants find these steps burdensome, or don’t understand the purpose of the research, they may disengage or drop out entirely before they’ve even begun. Integrating tools like guided eConsent and virtual patient training platforms can help to mitigate these risks, establishing ease and convenience up front while also providing necessary information—and setting the tone for the entire trial experience.  

eConsent

After recruitment, completing final consent documentation and screenings should be as seamless as possible. Reading a long-form, physical document can overwhelm potential participants—which is one of the reasons the progressive disclosure approach of online eConsent is so effective.  

Optimized eConsent is purposely designed so that patients receive critical information about the process, risks, and benefits of a study—paragraph by paragraph or in concise summaries—and move through this material at their own pace on their own mobile or computer screens. This method not only supports patients’ reasonable understanding of their role in the trial but also their engagement and adherence in later phases.

During the eConsent process, team members should be available to support patients, providing immediate answers to any questions they have. This can occur through in-app messaging or phone or video calls.  

If the study is complex (and most are), guided eConsent is recommended: A member of the clinical study team walks each patient through the consent forms via video conferencing or phone call—similar to the way informed consent would occur in a clinic, but patients don’t have to leave the comforts of home.  
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Patient training

Once patients are enrolled, effective training becomes key to converting those patients into engaged participants. When patients have difficulty with certain tasks or are unsure how to use necessary technology for trial participation, it can hinder their compliance and impact retention. However, intuitive technology—in combination with the support of a dedicated team—sets the stage for better patient education and higher patient activation.

The first of these components—technology—can simplify and enhance patient training by allowing participants to access, or revisit, content that describes their roles and responsibilities. Key features of virtual trial training include:

• An on-demand format, so patients (and caregivers, if needed) can complete training in more than one session.
• Full-time accessibility via the study app, so patients can refer to the training modules whenever needed.  
• Flexible, interactive training mediums—such as live online classes, phone calls, or animated videos—to accommodate different learning styles.  

However intuitive, virtual training is not likely to answer all participant questions or concerns, which is why a patient support team should be available at all times. These team members augment virtual training and encourage compliance by clarifying any misunderstandings and troubleshooting tech issues.  

For example, if a patient receives an error message on a device that measures daily blood pressure readings, that patient can consult the on-demand training material first. If the training doesn’t provide the resolution needed, the patient can then reach out to the support team for personalized guidance in real time.
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Intuitive Outcomes Measurement

Evidence of weak participant engagement often shows up in the data collection and outcome measurement stage. Sponsors can avoid pitfalls by leveraging an open line of communication between support teams and patients, as well as user-friendly data capture tools—including:  

• Next-generation ePRO (electronic patient-reported outcomes): Patients can use a BYOD mobile app for ePRO questionnaires. But, study teams need to consider how the questionnaire is displayed on every screen size and design it intuitively so it’s easy for patients to navigate. This may require seeking validation from the instrument’s creator.  
• Multifunctional image, audio, and video capture: Instead of asking patients to interpret symptoms, they can submit an image, video, or audio recording using their own smartphone devices. This data can then be transferred to raters for scoring.  
• Digital instruments, wearable devices, and biosensors: Wearable devices monitor and measure biological characteristics, such as heart rate, blood pressure, respiration rate, weight, temperature, blood oxygen and glucose levels, and ECGs. These devices reduce the need for site visits and produce more frequent data points, facilitating more robust data collection.
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Sensor or wearable selection

Incorporating wearable devices into a clinical trial can help reduce patients’ data capture onus. Many sensors capture data passively as patients go about their daily lives. The data is then automatically transferred back to the study team via a DCT platform.  

However, poorly designed devices can have a detrimental effect on a study. If a wearable is too complicated to use, the tech increases rather than decreases patient burden—and compliance rates will suffer. In order for these tools to truly reduce burden, study teams should work in conjunction with patient advisors to select the optimal device(s).

There are 6 key considerations that teams and their advisors must examine when vetting a device:

• Relevance: The device needs to be appropriate for the protocol and the disease state.  
• Usability: The device needs to be comfortable and easy to navigate (depending on how frequently it needs to be used).  
• Reliability: The device must be able to repeatedly take the measurement with no errors.  
• Validity: The device needs to provide accurate measurements of the underlying trait.  
• Safety: The device should be able to rapidly signal any health risks.
• Privacy: All data from the device should be encrypted.

When technology like sensors and wearables is used to capture data, there is one guarantee: Patients will have tech issues. Fear of technical difficulties often steers sponsors away from data capture innovations. As a result, both patients and sponsors lose out on the benefits of these technologies. But, by incorporating a team to provide on-demand patient support, the convenience of these devices can be enhanced while the compliance risks associated with them are mitigated.  
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Remote Patient Monitoring

In addition to streamlining data capture, implementing tech into a trial design can decrease participant burden by reducing the number of face-to-face, on-site interactions with clinicians. In such cases, remote patient monitoring (RPM) should be utilized to track patient safety and compliance.  

RPM can be key to optimizing patient engagement through a tech and team approach. As patient data flows into a decentralized clinical trial platform, virtual or site-based study teams monitor that data on real-time dashboards. Automated alerts, when programmed into the platform, can also notify study teams of any data outliers, including lapses in compliance or potential adverse events (AEs).  

Augmented by these technologies, teams are able to quickly reach out to non-compliant patients to answer any questions or concerns they might have and, when warranted, encourage them to get back on track. Tech-enabled monitoring also accelerates AE detection to make trials safer: If a data outlier is flagged and an AE is suspected, a study team member can intervene immediately, providing better support to patients.
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Final Thoughts on Patient Engagement in Clinical Trials

The belief that patient engagement is foundational to the clinical trial process has continued to impact the evolution of the industry since the HIV/AIDS epidemic in the 1980s. Despite this, the industry today still finds itself seeking answers to the same question that required solutions 40 years ago: How do we improve patient engagement? And, how do we bridge the gap between patients and researchers?  

Decentralized methods help sponsors achieve these goals, but remote tools only go so far. Instead, they must be part of a more holistic strategy that also provides patients with human connection.  

In this article, we’ve outlined methods for effectively combining technology and the human element, because it’s our belief that this approach is the promising next generation of patient engagement. Sponsors can partner with an experienced virtual research organization (VRO) to adopt a tech-and-team model that promotes human interaction, fostering consistent patient involvement from start to finish. In turn, these sponsors will reap the benefits of willing, engaged patients whose contributions unlock transformative research.

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