Archives: Agenda

• New FDA requirement for the Clinical Diversity Action Plans and why Clinical Trial Diversity is important in evaluating safety and efficacy of drugs
• CARER Group’s objective grading method for clinical trial diversity (CTD) and reporting of CTD scores of 92 drugs approved by FDA in 2022-2023.
• Example of best practices for achieving clinical trial diversity in USA

• Exposing the inefficiencies of current vendor qualification practices and challenging the industry to adopt a proven process innovation that will help Sponsors onboard Providers more quickly leading to a real reduction in clinical trial start-up times.
• Learn how embracing innovation, and adopting a risk-based data-driven approach to vendor management can help organizations strength their compliance practices in a heavily regulated industry.
• Uncover the advantages of a centralized approach to vendor qualification that provides unique benefits to both Sponsors and Providers across the globe.

• Exploring patient collaboration and the benefits it can bring to the sponsor and the patient.
• Importance of good communication to the patients and how this can streamline trial timelines
• Exploring how patients could, and should, be influencing decisions and the R&D process before study start-up.
• How to optimize collaboration with patient advocacy organizations
• Patient perspective ‘Pain Points’ throughout various trials

• The role of AI in dissecting disease pathogenesis
• Ways AI can improve success rates in neurodegenerative drug discovery and development
• Methods for accelerating CNS clinical trials with AI, enhancing patient journeys and drug accessibility

• Discussing the personal experiences of the patient
• Defining ‘patient centricity’
• Building clinical trials with the perspective of the patients in mind
• Patient access to the drug post study

• How early engagement will improve outcomes
• Speaking the same language – one size doesn’t fit all
• Simplifying the complex, in a world with an awesome amount of outsourcing options

• Importance of retention and growth of your team
• Openness to junior clinical team members
• Openness to bridge programs with your vendor partner
• Navigating these challenges in a hybrid environment