Season 4 Episode 2: Patient vs Process Bridging the Gap for a Better Trial Experience

This video provides an in-depth exploration of bridging the gap between patient experience and clinical trial processes, emphasizing a patient-centric approach. Hosted by Manny Vazquez, Senior Director of Clinical Data Strategy at Veeva, the episode features Joyce Moore, a leading voice in patient recruitment with 25 years of industry experience, most recently at Allucent. The discussion highlights the critical shift from viewing patients merely as subjects to seeing them as collaborators, underscoring the importance of understanding their lives and challenges outside the clinical setting.

The conversation delves into how patient engagement and site engagement are intrinsically linked, asserting that one cannot truly thrive without the other. Joyce Moore shares her journey from traditional patient recruitment to embracing decentralized trials (DCTs) and Electronic Clinical Outcome Assessment (eCOA) technologies, all driven by the goal of making trial participation easier for patients. She explains her team's role at Allucent in defining sponsor problems, developing patient-resonant materials, conducting digital outreach, and working with patient advocacy groups. A significant portion of the discussion focuses on the burden placed on both patients and sites by increasingly complex protocols, advocating for technology solutions that seamlessly integrate into existing workflows without adding undue stress.

The speakers also explore the ethical implications of data collection, questioning the necessity of extensive exploratory endpoints and advocating for an "endpoint-driven design" that focuses on critical data. They discuss the potential of digital endpoints as exploratory measures to pave the way for more patient-centric trials in the future, while acknowledging the need for regulatory acceptance and clear communication with patients. The concept of "immemorable" technology for sites is introduced, suggesting that the best technology is one that is so intuitive and integrated that site staff barely notice they are using it. The episode concludes with a powerful call to action for the industry to engage patients earlier, simplify protocols, and prioritize sharing data and trial progress back with participants.

Key Takeaways:

• Patient-Centricity is Paramount: Patients should be viewed as collaborators, not just subjects. Understanding their daily lives, challenges, and motivations is crucial for successful engagement and retention in clinical trials.
• Interconnectedness of Patient and Site Engagement: Effective patient engagement cannot occur without robust site engagement. Supporting sites and reducing their burden directly translates to a better experience for patients.
• Technology for Seamless Integration: Clinical trial technology, such as eCOA, must be designed to integrate smoothly into existing site workflows and SOPs. The goal is for technology to be "immemorable," meaning it's so intuitive that site staff don't even notice they're using it, allowing them to focus on patient care.
• Addressing Trial Complexity and Burden: The increasing complexity of clinical trial protocols places significant burden on both sites and patients. This includes long site visits, extensive travel, and the impact on patients' families, which can turn a short appointment into an all-day event.
• Protocol Optimization is Essential: There is a critical need for protocol optimization to reduce unnecessary data collection. Focusing on "endpoint-driven design" ensures that only data essential for proving the hypothesis is collected, potentially reducing patient and site burden.
• Ethical Data Collection: The ethics of collecting extensive exploratory endpoints, especially if their future use is uncertain, should be carefully considered. Every data point collected from a patient should have a clear purpose and value.
• The Value of Digital Endpoints: Digital endpoints, even when initially exploratory, are vital for gathering data that can lead to more patient-centric clinical trials and monitoring in the future, potentially replacing traditional, burdensome assessments.
• Transparent Communication with Patients: Explaining the "why" behind data collection and trial procedures to patients can significantly improve compliance and engagement. Treating patients like adults who understand the purpose of their participation fosters trust.
• Strategic Decentralized Trial (DCT) Implementation: While DCTs aim to reduce patient burden, the specific implementation (e.g., centralized home health vs. site-led home visits) needs to consider patient and site preferences. Patients, especially in pediatric or elderly populations, may prefer familiar site staff visiting their homes.
• Early Patient Community Engagement: Engaging patient communities as early as possible in the protocol design phase allows for true input, leading to lighter, more patient-friendly protocols that better reflect their needs and realities.
• Returning Data to Patients: The industry has a responsibility to give patients their data back, both personal health information and updates on trial progress. This reciprocates their significant contribution and provides valuable insights into their own health and the study's impact.
• Just-in-Time Training for Sites: Overburdening sites with extensive training should be avoided. "Just-in-time" training, delivered precisely when needed, is a more effective and less burdensome approach for site staff who are primarily focused on patient care.
• Cost-Benefit Analysis of Data Points: Attaching a value or cost to each data point can serve as ammunition for sponsors to critically evaluate the necessity of collecting certain information, potentially streamlining protocols and reducing overall trial costs.

Key Concepts:

• eCOA (Electronic Clinical Outcome Assessment): Technology used to collect patient-reported outcomes, clinician-reported outcomes, or observer-reported outcomes electronically, often via devices like tablets or smartphones.
• DCT (Decentralized Clinical Trials): Clinical trials where some or all trial-related activities occur at locations other than traditional clinical sites, such as a patient's home, using technology for remote monitoring and data collection.
• Endpoint-Driven Design: A methodology for designing clinical trial protocols that prioritizes the collection of only the data necessary to prove the primary and critical secondary endpoints, thereby reducing unnecessary data points and associated burden.
• Patient Burden vs. Site Burden: The cumulative physical, emotional, and logistical challenges faced by patients participating in a trial versus the operational and administrative challenges faced by clinical trial sites.
• Digital Endpoints: Objective, quantifiable physiological and behavioral measures collected by connected digital health technologies (e.g., wearables, sensors) that are relevant to a patient's health status.

Examples/Case Studies:

• Father of a child with a rare disease: A personal anecdote illustrating how a two-hour site appointment could translate into an 8-10 hour day for a patient and their family due to travel, preparation, and logistical challenges, highlighting the significant patient burden.
• Elderly patient population and home health: An example where sites expressed concern about centralized nurses visiting their elderly patients, preferring to send their own known staff. This underscores the importance of trust and established relationships in home health settings within DCTs.