There is a growing number of advanced therapies and newer treatments. The COVID-19 pandemic caused a backlog in drug development and restricted or prohibited patient participation in clinical trials. Decentralized clinical trials (DCTs) are a patient-centric model that can replace the traditional clinical trial model. They also allow for remote visits and telemedicine.
Although clinical trial sponsors might use remote and virtual technologies in patient-centric clinical studies to improve their outcomes, these solutions often do not promote patient engagement or retention. The pandemic has made it difficult to ensure patient participation and retention in clinical trials. Regardless of the trial’s design, reliance on eClinical Technology, or how complex they are, poor, inefficient virtual tools that support patient participation can lead to delays and cost increases. These tools can be optimized to maximize patient engagement, one of the main ways clinical trial teams can improve patient adhesion and retention, improve trial outcomes and open the door for promising new therapies.
Accessibility issues for providers and patients, combined with a reluctance to revisit the protocols and controls developed over decades of research, have slowed the adoption of virtual and remote technologies in the clinical trial space. Although the initial enthusiasm surrounding the concept was dampened by the limitations of DCTs, specific patient populations, and trial parameters were omitted, many people in the clinical trial industry have started to explore hybrid trials. These combine the advantages of a brick-and-mortar trial site with digital tools that can increase tracking, communication, and data breadth and depth.
Modernizing the protocols and technologies at the core of patient-centric trials is essential. These types of problems are already being pursued. However, remote engagement technologies have not been optimized for ease of use. This can lead to a disconnect between patients and providers, compromising a patient’s experience rather than improving it. Industries that provide applications for the consumer market are well-known for engaging, motivating, and motivating their customers. Peloton(r), Apple (r), Duolingo[tm], and Fitbit[r] use behavioral science principles to influence consumers’ decision-making and keep their users interested in their products. This insight drives innovation because these companies can understand what motivates their customers, what they expect, and what their preferred product experience is.
The eClinical tech industry, on the other hand, is still in its infancy in terms of using behavioral techniques to create applications for patients participating in clinical trials. These technologies lack the accessibility, immediacy, and engagement that more commercial products offer.
Improve Patient Engagement using Long-Standing Consumer Strategies Engagement through Technology in the consumer market means customers can set their own goals and overcome challenges. They also receive real-time feedback and can track their progress. These techniques are well-known to anyone who wears an Apple Watch(r) or FitBit(r) or has reached their “10,000 steps” milestone.
Technology gaps in clinical trials can harm patient perceptions and adherence. Trial participants who use apps and wearables to support their daily lives may become disoriented or frustrated with eClinical Technology. These considerations might seem secondary to drug developers or trial sponsors, but they can significantly impact a trial. If eClinical Technology is combined with better adherence, it has the potential to revolutionize the clinical trial paradigm.
This requires that we focus on behavioral science approaches that encourage user engagement to achieve it. Personalization and simplification are the two main drivers of this design. Configurable reporting tools that can be tailored to patients or populations have the potential to change the way a patient enters information. This can be further enhanced by machine learning (ML), which adapts to user’s preferences. The benefits start to compound, increasing trust among participants and streamlining trial experiences. This trust component is essential for patient-centric trials, which, by nature, tend to have less one-on-one interaction with patients and providers.
Modern, user-friendly UX design is key to driving patient engagement. This design should include dynamic personalization features that allow patients to have a personalized experience. This is important for sponsors who want to reach out to underrepresented communities and populations. Trial sponsors can improve adherence, data reporting accuracy, and troubleshooting by creating user platforms that enhance the patient-provider relationship.
Fundamental Behavioral Science Principles that Transform Clinical Trials
It has taken a while for consumer engagement techniques to be accepted in clinical trials. Several behavioral science principles have been validated and are highly applicable to clinical trials. They have also proven successful in other industries and applications. First the behavioral contract. This verbal commitment or written agreement to complete a task or program. This validated approach increases the likelihood that a participant will follow through on an ask. It is simple and effective. Time management and planning are other tactics that have helped to improve adherence to consumer applications. Many people find that a clear understanding of a program’s timeline and time requirements will increase their chances of successfully completing it. This paradigm can be used to motivate users by including “challenges.” Patients can feel more in control of their trial, track the tasks, and reward them with feedback or acknowledgments.
Real-time, or very close to real-time feedback from patients and clinicians, is one of the essential principles to improve adherence. The difference between receiving input from a clinician within a week and waiting two months for on-site visits is often significant. Participants will feel more in control of their trial progress if they receive faster turnaround times. This and the “challenge” principles are closely related to the idea of “social proof,” one of the most prevalent behavioral science methods in the consumer world. eClinical Technology can track a user’s progress relative to other users. This allows them to leverage social influence to integrate competitive elements into patient participation. Although social proof is sound, it may not be as easy in clinical trials. There are strict regulations regarding information sharing. However, anonymity can make it more effective in encouraging patient participation.
“success monitoring” is promising for increasing user engagement in clinical applications. However, there are similar limitations regarding anonymity and the degree of transparency required for this approach to work. Patients can understand and contextualize their progress in clinical trial protocols, which is one of the best ways to increase trust and improve adherence. This will open the door for patient-centric trials that achieve the same goals and are transparent.
To overcome obstacles and make progress.
Although there is much to be done in the clinical trial area regarding eClinical Technology, many stakeholders have begun to work with concepts like eConsent. These are valuable tools that have been implemented for many clinical paradigms. However, the following steps of advancing these technologies will require a more significant concerted effort by principal investigators, trial sponsors, regulators, and other stakeholders to identify engagement points and determine the best clinical strategies for optimizing remote engagement.
Integration of historically isolated applications will be another significant hurdle. For many trials, eConsent, ePRO, and eCOA are available separately. Additional applications can also be used to recruit participants or perform trial tasks. This creates distance and complexity for all involved, especially patients. Patients are often unfamiliar with the protocols of clinical trials and the user experience, confusing or non-intuitive. Clinical trial sponsors can simplify tracking patient participation by integrating disparate applications and programs into a single platform with an easy-to-use interface.
Patient-centric trials will only be possible if patients are met at their level and provided a positive, efficient experience. This will allow more patients to participate in practices and make accessing patients from rural and minority communities easier. Accessibility is a critical component of this initiative. Rural areas may not have access to the internet, so allowing eClinical Technology to record data offline and sync it later will enable them to participate in more trials. To support equity in the clinical trial space, it is essential to focus on the technologies and permissions necessary to support participants who cannot track their progress, often via enabling proxy.
Patients have come to expect high-quality virtual experiences. This quality can be achieved through clinical applications, which have the potential to revolutionize the clinical trial industry. Sponsors will have a better understanding of patient behavior and drive participation. Adherence can also be improved using proven behavioral science principles.
