An Elligo Elite Learning Series Discussion
Decentralized trials continue to change the clinical study landscape, introducing new ways to approach research. The explosion of these nontraditional models is coinciding with a sharper focus on patient centricity, adding a new wrinkle to the planning process. How can optimized trials help enroll a more diverse patient population and increase retention? And what else does the future hold for research teams and patients in decentralized trials?
“Patient-Centric Research: How Optimized Trials Enhance Patient Enrollment, Retention, and More” is an Xtalks webinar focused on the benefits of trial optimization for patient centricity. Moderated by Corey Stanton, this discussion features Elligo’s CEO Barry Simms, Senior Director of Patient Solutions, Leslie Carney, Chief Product Officer, Jacylyn Dougherty, and Chief Medical Officer, Dr. Faith Holmes. During their conversation, they cover patient recruitment models and strategies, tips for successfully implementing technology, observations and ideas on site-level processes, and practical information on what regulatory agencies are looking for, which is all followed by a Q&A.
Defining Optimized Trials
To get the conversation started, Barry introduces a poll to determine what terminology is most commonly being used to describe nontraditional trials. With that audience input, he explains the concept behind “optimized trials” and how they fit into the current trial landscape. To tee up the deeper discussion on trial optimization, Elligo’s history and area of expertise are recounted, and before moving to the next topic, a second poll is presented to determine what level of experience the webinar participants have with optimized trials.
Patient Recruitment Strategies for Virtual Studies
Leslie then kicks off a discussion about recruitment, evaluating the nuances of deploying organizational tools and strategies in an optimized setting. She begins with an introduction to Elligo’s direct-to-patient outreach and insight into the importance of a consistent patient experience and how to achieve it. Strategies for furthering diversity through trial design and conduct are explored, as well as solutions for helping virtual study teams build trust in underrepresented communities. Leslie raises some of the questions to address when determining documentation requirements. She concludes by stressing the need for consistency and recommends viewing the trial through the patient lens.
The Patient and Physician Journey With Technology Considerations
Jackie picks up the discussion, moving into technology and observations about the challenges created by the unique and complex ecosystem of each study. She explores where current technology stands in relation to optimization needs and then offers examples from Elligo’s history, including monitoring and auditing issues. She touches on the burdens some technologies create before discussing successes virtual study teams have made using Elligo’s system. After making her initial points, Jackie details key considerations for choosing a technology for optimized trials, exploring efficient and collaborative workflows that remove burdens and barriers. This includes strategies to ensure the right data are collected at the right time. Dr. Holmes mentions the importance of technology that can pivot with the needs of optimized trials, but she also stresses the part people play in using the technology to its full potential.
PI Oversight in Centralized Services
Dr. Holmes next looks at PI oversight, emphasizing Elligo’s focus on collaboration and the importance of having a centralized study team for efficiency and expertise. She then defines and provides information on two decentralized trial models: the virtual model and the hybrid model. After exploring the impact of these models on monitoring visits and general communication, she explains Elligo’s unique model. Following insight on the importance of feasibility evaluations, she then discusses the main focuses of the FDA during an audit process and their interest in strategies that offer comprehensive solutions. She concludes by suggesting questions to ask when choosing a trial format.
Wrap-up and Q&A
Barry takes over to present the third poll question, which asks audience members about their future plans for optimized trials. He then discusses how trial design is evolving because of new technology and solutions across the industry. The conversation ends with a question and answer session that addresses the importance of collaboration, how data collection and workflow can complement one another, effective strategies for enrolling patients from underrepresented communities, how central PIs fit within optimized models, the right time for patient engagement, and recommendations for effective technology.
For Patient-Centric Trial Optimization, You Need Elligo
Get all these important insights and valuable advice by watching “Patient-Centric Research: How Optimized Trials Enhance Patient Enrollment, Retention, and More.” And don’t forget to contact our team to enhance your decentralized trials.