Authors: Amy Fasiczka, ePro Solutions Design Architect, Melissa Newara, Senior Director, Subject Matter Expertise and Jose Carrillo, Manager, User Centered Design
The clinical trial space has transformed rapidly over the last several years, spurred by increasing trial complexity, the need for greater accessibility across patient populations, and increased interest in decentralized trial models. This has led to a surge of eClinical technologies designed to support remote trial activities, facilitating a more streamlined, engaging experience for trial participants.
One of the driving factors in the design of these technologies relates to user experience. Ideally, a decentralized or hybrid trial improves upon patient recruitment and retention – historically, traditional trials commonly experience delays of up to six months as a result of recruitment issues[1] – through technologies designed with user experience in mind. Moreover, eClinical technologies have the potential to transform the patient experience by offering users more personalized, tailored interfaces, with platforms that are easy-to-use, designed for accessibility, and structured to give both users and trial coordinators better insight into their progress.
Crafting a user-friendly experience for research participants is critical and should be the primary focus throughout a trial, taking into consideration every participant that may potentially be involved. Factors such as the level of training a participant may need, their technology literacy, and achieving true participant inclusivity through ease of access and usability are all part of realizing an eClinical platform positioned to help a trial succeed. By prioritizing patient centricity within a platform’s design, sponsors can tailor patient engagement to achieve specific outcomes based on a study’s indication, patient population, and end goals.
eClinical Technologies: The Right Information, the Right Way, at the Right Time
Ensuring patient engagement and, in turn, retention has long been a core challenge for the clinical trial space.[2] Issues surrounding a lack of patient diversity,[3] as well as challenges related to participant burden, narrow eligibility criteria, and lack of recruiter engagement,[4] have all served to hamper recruitment. The result is a paradigm in which only one-third of all clinical trials recruit their participants as planned.[5]
As more trials move toward decentralized and hybrid designs, addressing this challenge becomes an opportunity to transform the face of patient engagement through technologies tailored to deliver the right information in the right way at the right time. Take enrollment – in a traditional, site-based trial, the process of securing consent is paper-based, with trial coordinators who can help guide participants through dozens of pages of documents. Transitioning to an eConsent platform might then be as simple as digitizing these documents in an electronic format for participants to review at home.
However, establishing the best eConsent platform for a trial design is typically more involved than merely pursuing digitization. The right eConsent paradigm, whether remote, onsite, or hybridized, will have the tools in place to support paper-to-digital workflows, multiple signatures, and features designed to both gauge and bolster comprehension. By streamlining those existing documents through, accessible language and interactive elements, an eConsent platform can achieve better engagement and understanding on the part of participants.[6,7] The streamlining and interactivity enabled by eConsent can go a long way to improving understanding in a landscape where, according to the Society for Clinical Research Excellence, consent forms are getting longer, and no standardization exists around comprehension
testing.[8]
Prioritizing participants’ differing needs and comfort levels is crucial to achieving better retention; for many, the stressors accompanying their illness, their living situation, economic status, and support network can limit their ability to engage at the same level as other participants. Additionally, the increasing complexity of the clinical trials in today’s ecosystem warrant solutions that offer participants more accessible, comprehensible information about a trial at every phase. At Medrio, we have worked to create an eClinical platform that is accessible, intuitive, and engaging, with a web-based, cloud-based interface that is device agnostic, allowing participants to use their phones or tablets without downloading a separate application. This stems from our belief that technology should never limit trial participation, which is why we also work with partners to provision devices for participants who need them. For the web platform itself, applying responsive web design that focuses on accessibility has allowed us to create a user interface that works across various devices and a wealth of different participant experiences and considerations.
Meeting Trial Participants Where They Are
There are, of course, elements of many trial designs that cannot be recreated in a participant’s home. But the best means of centering participant experience lies with flexibility in design. For some, the best option may be on-site and in-person, and others may require ongoing flexibility. The ability to meet participants where they are applies to all patient-centric technologies including eConsent and electronic patient-reported outcomes (ePRO). A truly patient-centric approach must consider when an eClinical solution is insufficient to address the needs or comfort of a given participant, no matter how simple or optimized the technology.
Finding the right eClinical technology is important to establishing a patient-centric trial design. Equally important is finding a technology partner that can support users on both the coordinator and participant sides, reducing site burden and enhancing patient experience in iterative, collaborative ways. The right eClinical technologies, with the right people supporting them, can close data gaps, reduce context switching, and facilitate closer communication between participants and study professionals.
One of the key advantages of Medrio’s platform is that it convenes every interface in one place, with one purpose: to establish a robust, flexible electronic Clinical Outcome Assessment (eCOA) ecosystem. For app-based technologies, data storage is often split, with ePRO data and EDC housed separately. Our platform convenes these data streams and others, enhancing interoperability and fostering a natively integrated system able to follow participants from the start of their trial journey to the end. This approach also greatly simplifies the user experience for trial coordinators accustomed to navigating multiple (often siloed) technology platforms, providing a centralized, interconnected hub capable of offering enhanced insights across every facet of a trial’s execution.
Better Data Through Collaboration
Helping participants understand the technologies designed to support their clinical trial journey is key to establishing and improving these platforms. This starts with ensuring buy-in at the site level – ultimately, the right technology partner must work to make site coordinators comfortable enough with a technology to not only use it themselves but to effectively train participants on it. At Medrio, we work to level-set with a partner to understand their existing workflows and practices. That way, we can not only better educate them on our platform by drawing parallels with their own, but also identify any potential gaps on either side that can be addressed to strengthen the platform. Additionally, our guided autonomy approach affords customers both the support they need to problem-solve in complex scenarios and the independence necessary to achieve independent study builds. This, in combination with a unified database that integrates ePRO and EDC, affords users the interoperability and usability to make study changes and align workflows for better, simpler study management.
In the end, every study needs quality data. Finding a partner that can offer a tailored, streamlined user experience that fits the needs of a study without introducing unnecessary complexity can help sponsors collect complete and high-quality data, bolstering a study’s odds of success. For many across the clinical trial space, there exists this idea that increasingly complex studies require equally complex solutions to meet their needs. While some level of complexity may be necessary for technology to meet certain requirements, complex systems often serve to create unnecessary layers of complication, resulting in inefficiencies, personnel burnout, participant attrition, and timeline delays. To combat this, Medrio has methodically engineered its platform to handle complexity without compromising utility and user experience.
We at Medrio approach UX design from every angle, from aesthetics to readability to interactivity and accessibility, all to create a user experience aligned with a participant’s needs and a study’s goals. By streamlining the information patients encounter to emphasize what’s most important, we help lower attrition and increase engagement. Convening tools into one centralized platform makes it easier for participants and providers alike to navigate their care. And by continuing to iterate on our platform to fit the needs of a changing clinical trial landscape, we help trial coordinators transform the participant experience, improving outcomes and keeping studies on time and on track.
References:
[1] Gogtay, N., Chaudhari, N., Ravi, R., & Thatte, U. M. (2020). Recruitment and retention of the participants in clinical trials: Challenges and solutions. Perspect. Clin. Res, 11, 64-69.
[2] Fogel, D. B. (2018). Factors associated with clinical trials that fail and opportunities for improving the likelihood of success: a review. Contemporary clinical trials communications, 11, 156-164.
[3] Woodcock, J., Araojo, R., Thompson, T., & Puckrein, G. A. (2021). Integrating research into community practice—toward increased diversity in clinical trials. New England Journal of Medicine, 385(15), 1351-1353.
[4] Briel, M., Elger, B. S., McLennan, S., Schandelmaier, S., von Elm, E., & Satalkar, P. (2021). Exploring reasons for recruitment failure in clinical trials: a qualitative study with clinical trial stakeholders in Switzerland, Germany, and Canada. Trials, 22(1), 1-13.
[5] Laaksonen, N., Bengtström, M., Axelin, A. et al. Success and failure factors of patient recruitment for industry-sponsored clinical trials and the role of the electronic health records—a qualitative interview study in the Nordic countries. Trials 23, 385 (2022). DOI: 10.1186/s13063-022-06144-9.
[6] Zeps, N., Northcott, N., & Weekes, L. (2020). Opportunities for eConsent to enhance consumer engagement in clinical trials. The Medical Journal of Australia, 213(6), 260.
[7] Kirsch, M. (2000). The myth of informed consent. The American Journal of Gastroenterology, 95(3), 588-589.
[8] Davis, T. C., Berkel, H. J., Holcombe, R. F., Pramanik, S., & Divers, S. G. (1998). Informed consent for clinical trials: a comparative study of standard versus simplified forms. JNCI: Journal of the National Cancer Institute, 90(9), 668-674.
