Prioritizing Patients: Strategies and eCOA Best Practices in Drug Development

Mike Hughes, Chief Product Officer, YPrime

Kristy Birchard, Product Owner - Patient Engagement, YPrime

The field of drug development is placing a growing emphasis on the importance of patient perspectives. Regulatory bodies are increasingly incorporating patient experiences into the decision-making process. The FDA's Patient-Focused Drug Development (PFFD) guidance series exemplifies this commitment. The PFFD outlines best practices for sponsors, trial sites, and providers to gather robust and meaningful input from patients and caregivers. This patient-centric approach informs investigational drug development and ultimately leads to better regulatory decisions.

Recognizing the importance of patient priorities in weighing treatment risks and benefits, the FDA's PFDD initiative takes a multi-pronged approach. This includes PFDD meetings for patients, caregivers, and advocates to share experiences, developing Patient-Reported Outcome Measures (PROMs) to capture patient perspectives, incorporating patient input into regulatory decisions, fostering collaborative communities with various stakeholders, and providing guidance documents encouraging industry-wide patient involvement throughout drug development and evaluation.

To fully integrate PFDD into clinical trials, researchers need digital tools designed to collect the right patient data at the ideal moment. Electronic clinical outcome assessment (eCOA) technologies fill this critical gap, revolutionizing how patient-reported outcomes (PROs) are gathered and managed. eCOA allows patients, clinicians, and even caregivers to electronically submit data on symptoms, quality of life, and treatment outcomes.However, this shift from paper to electronic systems requires careful planning. Priorities include ensuring data quality and integrity, meeting regulatory requirements, bolstering data security and privacy, and minimizing errors that could compromise patient safety.

Transform eCOA with guidance from patients

Implementing an eCOA system for PFDD requires a comprehensive approach focused on best practices. This means enabling real-time patient reporting, enhancing data quality and accuracy for reliable patient-reported outcomes, and streamlining data analysis to minimize errors, eliminate transcription needs, and expedite evaluations that inform regulatory decisions. Regulatory alignment during implementation and migration is crucial, along with patient-centric design that leverages best practices for user-friendly, patient-centered ecosystems that can further inform drug development. Additionally, prioritizing accessibility and inclusivity ensures participation from diverse populations, improving data generalizability. Increased patient convenience through remote and flexible data entry, coupled with improved engagement through engaging platforms, fosters better protocol adherence and active participation in the trial.

The rise of patient-centric clinical trials

The landscape of clinical trials has shifted dramatically in recent years. Advancements in technology, the COVID-19 pandemic, and the rise of decentralized studies have all contributed to a heightened focus on patient centricity. This necessitates ongoing engagement with patients, recognizing the invaluable role their lived experiences play in scientific progress and drug development.

This shift aligns with the principles of participatory research, where communities are viewed as crucial stakeholders in defining their needs and research priorities. It also echoes the core tenet of disability rights advocacy: no decisions should be made about a population without their input.

Patients and caregivers possess unique knowledge that traditional research methods may miss. Building relationships, collecting real-world data, and fostering community outreach are essential to capturing these insights. A transformation in clinical trial organization requires a cultural shift within institutions, moving beyond the outdated model of patients as passive participants. By creating a more equitable research ecosystem with improved accessibility, companies and sponsors can build stronger relationships with patient communities, enhance technology usability, and ultimately advance product design and implementation.

The importance of user experience (UX) in eCOA platforms

Developing an eCOA platform that aligns with PFDD requires a focus on user experience (UX). While often used interchangeably, UI (user interface) and UX are distinct concepts. UI refers to the visual elements of a platform, such as color scheme and layout. UX, on the other hand, focuses on the user's overall experience interacting with the platform. This includes factors like ease of navigation, intuitiveness of data entry, and clarity of information architecture.

In the context of eCOA, well-designed UX prioritizes a simple and intuitive data entry experience for patients. User-centric design empowers patients by minimizing confusion—particularly important during potentially challenging times. This simplicity also reduces the potential for errors and ensures the collection of high-quality data. Patient-facing applications can be designed with features that send reminders for medications, appointments, and data reporting, maximizing protocol adherence and data completeness.

Source: YPrime

This focus on user-centricity is crucial for promoting patient diversity in clinical trials. By catering to varying levels of technical proficiency and accommodating users with disabilities, eCOA platforms can ensure a more inclusive experience. A positive UX experience can further enhance trust in the trial process and the sponsoring organization, ultimately leading to higher recruitment and retention rates.

Optimizing eCOA design with lean UX

Clinical trial technology providers can prioritize user experience through Lean UX, an iterative design approach focused on continuous improvement and positive user outcomes. For example, Lean UX can be employed to prototype an eCOA application, creating two versions with varying visual elements (color scheme, fonts, icons). Testing these versions with participants from the general population allows for broader feedback, not just on aesthetics but also on functionality like login, questionnaires, and data submission.

Source: YPrime

This iterative process, informed by user feedback, leads to refinements in navigability, design, and overall user experience. A commitment to research-driven design, including Lean UX, ensures eCOA solutions are user-friendly and promote positive patient experiences.

Optimizing patient engagement through design thinking

Design thinking, a non-linear, iterative research methodology, can be employed to enhance UX within the development process. This approach prioritizes uncovering user needs and fosters innovation. Design thinking consists of five key phases: empathize, define, ideate, prototype, and test.

In the context of eCOA development, design thinking can be utilized to understand patient needs. The "empathize" phase involves creating patient personas—detailed profiles representing diverse patients with varying health conditions, technology skills, and backgrounds. These personas inform the "define" phase, where potential issues and unmet needs are identified.

Following this, the "ideate" phase involves brainstorming and developing different graphic styles for engagement features within the eCOA platform. These concepts are then refined and translated into prototypes for the "prototype" phase. User testing with diverse participants, aligned with the established patient personas, is conducted during the "test" phase. This iterative process, involving surveys, interviews, and feedback analysis, allows for refinement of the graphic style and overall user experience.

By leveraging design thinking, eCOA platforms can cater to a wider range of patient needs and preferences. This commitment to in-depth user research ultimately leads to more engaging and user-friendly eCOA platforms, promoting positive patient experiences within clinical trials.

Empowering patients through user-centered eCOA design

A commitment to user-centered design, informed by comprehensive research (surveys, interviews, user testing), drives continuous improvement in eClinical platforms. This iterative process, analyzing participant feedback and broader technology use, ensures eCOA platforms become progressively more accessible and user-friendly. By prioritizing patient experience, participants are empowered with intuitive tools, ultimately fostering greater engagement and advancing clinical research through a more mindful patient population.

This approach is particularly valuable in a complex industry where patient conditions can hinder trial participation. User-centered design allows for the development of flexible eCOA platforms that enhance engagement and promote motivated participation, ultimately leading to a more robust patient voice in research.

Mike Hughes, Chief Product Officer, and Kristy Birchard, Product Owner - Patient Engagement, both with YPrime