Commentary Contributed by Bruce Hellman, uMotif 

April 19, 2024 | The proliferation of mobile technology—including multiple generations of progressively smarter phones, tablets, watches, and other devices—has set the stage for similar types of eClinical innovation. However, the two types of technologies have not progressed at the same pace. This is unfortunate for all clinical trial stakeholders and, most notably, patients. 

We’ve seen rapid innovation and adoption of mobile technology. In the two decades since their introduction, there are approximately 6.84 billion smartphones in the world. While mobile devices have become powerful, sophisticated, and technologically complex, they also have become easier to use and more intuitive, making them a preferred channel for transacting. This is because smartphones have been designed from the ground up with the user at the center of the experience. 

Clinical trial applications, including legacy eCOA/ePRO, have mostly followed a different path. While the industry has made some inroads toward patient centricity, most apps, like trial protocols themselves, have been designed primarily from the perspective of sponsors and investigators—not participants. 

Historically, many clinical trial data capture systems were designed first and foremost with a focus on the outcome measure. Attention to how best to obtain such measures from patients or healthcare professionals was secondary. For example, many eCOA/ePRO systems have simply digitized paper-based questionnaires for mobile devices with little consideration for patient usability and the new digital medium. 

This data measurement-first approach has led to solutions that are often difficult and burdensome for patients to use. Entering data is seen as another chore and requirement for participants, without providing the immediate rewards we’ve all come to expect from other digital experiences. The result is often lower patient engagement; more burden on the site to chase patients; and longer, more costly clinical trials. 

We can and must do better for participants, and it starts with three core practices that are key to developing technologies and apps that encourage patients to get and stay engaged and compliant. 

1. Deliver a delightful experience – Technology providers must understand that the true competitive environment is for people’s time; therefore, the digital experience must be delightful and rewarding, and on par with the experience delivered by everyday consumer applications.  
    
   As ePRO compliance becomes increasingly critical in the performance of a study, it’s vital that the application does everything possible to encourage rather than dissuade usage. It starts with, but goes far beyond, providing an engaging, easy-to-use interface—something that we have come to expect from digital applications. Consumers increasingly want applications that are entertaining and immediately rewarding, and patients are bringing these same expectations to clinical trials and eCOA/ePRO technology. Feedback loops, rich content, and gamification are a few examples of how eCOA/ePRO solutions can rise to this challenge. 
   

2. Encourage engagement through intuitive design – eCOA/ePRO must not only support the patient’s journey. It also should make it simpler to take part in a study by giving patients the right information and resources. Navigating a clinical trial can be a complicated experience, especially for patients experiencing a serious illness. eCOA/ePRO can encourage engagement, which in turn drives higher retention and better data by first providing—in one place—all the information, resources, and virtual signposts needed to successfully participate in the clinical trial. In essence, it functions as a virtual home for the trial.  
    
   By acting as a comprehensive, dynamic, and engaging source of content (such as study updates, information about conditions, and additional resources), reminders, notifications, and information, a modern eCOA/ePRO system can serve as a patient’s welcome companion through the study—increasing their engagement and understanding of the study, as well as their role in it. The platform should also make it easy to share resources with family members and caregivers who walk with and support the patient on their journey.  Giving participants useful information and an intuitive app that becomes an integral part of their research experience makes data entry and engagement a “want to do” versus a “have to do” in a patient’s already busy life.  
    
   In addition, behavioral models can be used to create an engagement feedback cycle that increases study engagement. The model supporting the engagement feedback cycle identifies and measures participant challenges, and then determines the steps needed to maintain or increase engagement. The patient’s experience becomes personalized, dynamic and responsive, either via automated interventions or sites taking recommended actions. 
   

3. Recognize and reward engagement – We must ensure that patients feel valued and appreciated for their many sacrifices and contributions and understand that the journey is worthwhile not only for them but for generations to follow.  
    
   It starts with appreciation and thanks. A short note when a patient signs up is only the first step. Creative opportunities for appreciation extend throughout the study, whether through updates on trial milestones and progress, as well as upon study completion when the results can be shared. Modern ePRO/eCOA systems provide many ways to do this with little or no additional cost. 
    
   Furthermore, opportunities for appreciation and support can continue even after the study has concluded. For example, sponsors may offer patients the ability to continue using an eCOA/ePRO app to input and visualize their data as part of their own healthcare journey. Participants in the 100 For Parkinson’s study valued the ability to continue to access their own data, and some used the app for years after the end of the study. 
    
   In addition, AI and machine learning (AI/ML) technologies are presenting new opportunities to think even more creatively about the right way and right time to say thank you to and encourage participants. 
   

Modern eCOA/ePRO systems can do so much more today to meet the needs of sponsors and deliver a far better patient experience. Near ubiquitous adoption of mobile technology combined with rapid advances in AI/ML set the stage for a new era of eClinical apps. The key to success is a human-centric focus from the ground up.  

Digital technology is most effective when it starts with human relationships and behaviors and then introduces technology into the equation to enhance and advance outcomes. To achieve this goal, however, it is essential to seek patients’ input at the early stages of design and development and incorporate it in a way that optimizes the user experience and ensures effective data collection. With this commitment to truly understanding the needs of patients as individuals, clinical trial technology will fulfill its full potential. 

Bruce Hellman is Chief Patient Officer and Co-Founder of uMotif. He can be reached at bruce@umotif.com.