The NextGen of Clinical Trials: Patient-Driven or Tech-Driven?

Moderator

Danny Yeh, PhD, Aesara, Burlingame, CA, United States

Speakers

Tracey Sikora, BSc, National Organization for Rare Disorders, Washington, DC, United States; Ebony Dashiell-Aje, PhD, BioMarin Pharmaceutical Inc, Washington, DC, United States; Selena Daniels, PharmD, PhD, US Food and Drug Administration, Silver Spring, MD, United States

Purpose: With new advances in technology, how does the future of patient-centricity look? Emerging technologies like artificial intelligence, virtual reality, and digital platforms are integrating with traditional methods, such as qualitative interviews, surveys, and clinical outcome assessments (COAs), to personalize and improve patient care. These innovations create new opportunities to evolve care models (e.g., trials catered to individual needs, decentralized trials) and to inform decisions by regulators and payers. This session will examine how these tools and technologies can be used to systematically collect and/or generate high quality, data-driven, insightful patient experience data (PED) for decision-making and integration into the design and delivery of care. Description: Danny Yeh (AESARA) will open the session with a brief presentation that introduces core concepts, emerging technologies, and current use cases. He will then moderate the discussion on the integration of these technologies in clinical trials, drawing on insights from payers and HTA decision-makers. In response to this, the panel will provide perspectives from patient advocacy (Tracey Sikora; NORD), industry (Ebony Dashiell Aje; BioMarin), and regulatory (Selena Daniels; FDA). The panel will explore: • Why are we entering a new era in how we approach patient partnership and empowerment in clinical trials? • How can technology be integrated with traditional methods to ensure clinical trials are shaped by what matters most to each individual patient? • How does the rise of artificial intelligence and machine learning may influence the collection and use of PED? • How is the integration of PED collected in routine care (real world evidence) with traditional clinical trial data in decision-making? What standards need to be in place? • What to expect in the coming years and what issues warrant close attention The session will include interactive polling questions and time for audience questions and open dialogue.

Topic

Clinical Outcomes, Medical Technologies, Patient-Centered Research

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