Archives: Agenda
Assessing patient attitudes to the use of AI in clinical trials
- Review the results of a public and patient survey on the use of AI to develop clinical trial documents
- Assess patient level of trust in and comfort with the use of AI to generate patient-facing clinical trial documents
- Discuss the patient’s views on the importance of human review of AI-generated content and implications for the future
PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS
During the roundtable discussion session, the conference hall will be divided into four ‘zones’. Delegates can choose which zone they would like to join. Each zone will be led by a table moderator and will focus on a different challenge within clinical operations. Roundtables will take place in the Stream A conference room.
| ROUNDTABLE 1: Importing and exporting biological materials to or from the U.S
Sean D. Smith, Biological Threat Exclusion Coordinator (BTEC), U.S. Customs and Border Protection Baljeet Kaur, Agriculture Operations Manager, U.S. Customs and Border Protection |
| ROUNDTABLE 2: Pros and cons of different outsourcing models: FSO vs FSP vs inhouse
Yolanda Wan, Head of Clinical Operations, Orna Therapeutics |
| ROUNDTABLE 3: Enabling the most inclusive approach to patient engagement
Lily Cappalletti, Director, Patient Experience, Alexion Pharmaceuticals |
| ROUNDTABLE 4: Topic TBC
Kate Tith, Vice President, Head of Clinical Operations, Dyne Therapeutics |
| ROUNDTABLE 5: Building efficient and effective relationships with sites
Peter Koefler, Director, Study Site Engagement, Takeda |
Cardiac data matters: keeping patients at the heart of innovation
- Discover how to achieve unparalleled accuracy and patient compliance through cutting-edge, low-touch technology
- Dive into the transformative power of AI and explore real-world applications reshaping cardiac care
- Understand how continuous monitoring ensures precise data collection and enhances patient adherence and safety
- Uncover the revolutionary role of AI in interpreting cardiac data
- Review practical examples and case studies demonstrating effectiveness of continuous cardiac monitoring in clinical settings
Considerations for successful third party vendor management
- What degree of oversight should you have over third party vendors?
- Risks and benefits of handing third party management to CROs
- Regulatory and quality considerations around outsourcing to third party vendors
Diversity Action Plans: preparing, submitting, and receiving regulatory feedback
- An overview of recent US legislation around diversity in clinical trials
- Understanding requirements around DAP approval and submission: what should you include?
- Preparing documentation to demonstrate diversity in your clinical trial
- Experience with DAPs in view of the received FDA feedback
Afternoon refreshments and networking break
Fostering a productive CRO/Sponsor relationship and factors to consider before undertaking a transition to a new CRO
- Planning for a successful sponsor/CRO relationship
- Defining goals, priorities and metrics
- Considerations when contemplating a CRO transition
- Overview of common challenges and pitfalls in CRO transitions
- Developing a detailed transition plan to minimize disruptions and ensure continuity
Patient-guided by design: a framework for successful study start-up, informed protocol design and better outcomes
- Optimizing study-start up for improved timelines and site performance
- Integrating patient input into protocol design and the impact of patient motivation assessments
- Case studies: patient-informed protocol design for successful outcomes