Archives: Agenda

• Redefining hope: navigating tough conversations about disease-modifying treatments.
• Genetic testing’s unexpected role in driving patient enthusiasm for trials.
• When science outpaces understanding: bridging the gap with patients and clinicians.
• Lessons from case studies

• Overcoming regulatory hurdles: How are agencies responding to new technologies?
• Ethical considerations: Ensuring patient data privacy and compliance.
• Operational barriers: Integration with existing trial frameworks (or do we need to adapt?)
• Future Outlook: What technologies will dominate in the next 5–10 years?

Chair: Joshua Cox, Vice President of Clinical Data & Analytics Capabilities, Eli Lilly and Company

• Designing and executing a successful RBQM framework to meet your specialized trial goals
• Sharing best practice on implementing new modern EDC systems to provide built-in validation checks and automated information checks when some CROs are lacking
• Focusing on critical data and processes by documenting risks, roles, and mitigation strategies
• Meaningful key performance indicators for RSQM

• How is the industry approaching diversity and what should the primary focus be?
• Increasing accessibility to trials whilst simultaneously maintaining an appropriate level of patient safety
• Assessing the link between restrictive eligibility criteria and rates of serious adverse events to make informed decisions on expanding exclusion conditions
• Alternative solutions to improve patient numbers amidst pressures to hit recruitment milestones
• How have increased pressures of patient recruitment lead to the questioning of traditional enrollment methods?

Chair: Cathy Scharf, Patient Advocate, Patient Advocates of the East Bay

• In-home trial delivery makes participation easier, more convenient and more accessible
• Increasing trial access to more patients by empowering and supporting a variety of community research sites
• How trial design can deliver increased recruitment and retention in a cost-effective way