- The challenge: unstructured data in RWE studies
- GenAI in action: structuring unstructured data and deriving insights
- Implementing GenAI: best practices and strategic considerations
Archives: Agenda
Is your protocol leading to success? The importance of early engagement
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PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS
During the roundtable discussion session, the conference hall will be divided into two ‘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 in oncology trials. After 30 minutes, delegates will have the opportunity to swap and choose a different table, and each roundtable will run twice.
ROUNDTABLE 1
Exploring ways to involve patients in clinical trials to advance patient recruitment and retention with regulatory considerations
Dr. Jasmin Barman-Aksözen, Research Investigator, Lecturer and Rare Disease Patient Advocate, University of Zurich
ROUNDTABLE 2
How can we be more efficient in clinical operations with less resources?
Nicolas Schneider, Director Clinical Operations and Alliance Management, ITM Isotopen Technologien München
ROUNDTBALE 3
Aligning clinical teams with supply teams earlier to improve processes and output
Jasmin Hellwig, Associate Director Vendor Relationship Management, MSD
Integrating digital health technologies in clinical trials
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Chairperson’s closing remarks
Innovative thinking for increasing patient diversity and inclusion in clinical trials
• Increasing diversity in clinical trial patient recruitment
• Understanding why diversity in clinical trials is important for trial outcomes
• Exploring how to advance medicine through increased diversity
Lunch and networking
Key considerations and strategic steps to ensure successful and timely execution when planning your first clinical trial as a start-up company
- Understanding the timeline from the initial idea to the first patient enrolment
- Assembling a powerful team within your company
- Creating a realistic project plan and budget
- Gaining a thorough understanding of the regulatory and competitive landscape
- Carefully considering the design of your trial, patient availability, the number of patients needed, and the number of sites/countries involved
- Choosing the right partners, including CROs, vendors, and sites
Developing the first treatment for my own ultra-rare disease – lessons learned
• Meaningful involvement of patients in the study design phase to reflect their needs and improve trial execution
• Ethical aspects of trial designs in ultra-rare diseases
• Partnering with patient advocacy groups to foster meaningful relationships
• Experiences and lessons learned from being a patient representative in regulatory approval and HTA proceedings
PANEL DISCUSSION Enhancing communication between CROs, sponsors and clinical trial sites for an efficient work process
• Emphasizing the importance of defining clear communication channels, expectations, and escalation procedures among CROs, sponsors, and sites to ensure transparency and accountability throughout the trial
• Highlighting the benefits of leveraging communication technologies such as centralized platforms and project management tools to facilitate real-time information sharing and collaboration among stakeholders
• Providing training and resources to enhance communication skills and promote effective teamwork across all levels