Is your protocol leading to success? The importance of early engagement

  • Optimizing a protocol requires going beyond benchmarking historical clinical trials for any disease
  • It must involve pressure testing the protocol synopsis with key stakeholders, including investigators, site coordinators, and patients.
  • This stakeholder engagement process best ensures that your protocol will be as site and patient-friendly as possible
  • The Protocol Nexus and Protocol Optimizer offerings from Syneos Health Consulting help solve these problems by providing expert guidance and tailored solutions

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

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