Early-Stage Considerations for Maximizing Success in Initial Oncology Clinical Trials

This webinar will highlight the many aspects a company must consider in planning and executing a trial, and how a CRO can help throughout the process. They include:

• ·Developing a strategy
  • Determining your short- and long-term strategies
  • Beginning with the end in mind and using a strategic planning tool called a Target Product Profile
• Translational medicine considerations
  • How to maximize the potential for developing a predictive biomarker
  • PK, PD
• Defining the objectives of the initial trial
  • Go/no-go criteria
  • Objectives and adaptive designs in early oncology trials
  • Proof of concept, mechanism, efficacy, target
  • Safety, clinical endpoints
• Operational considerations
• Choosing the right CRO for your company

• Paul Hallenbeck, Executive Director, Drug Development Strategy, Oncology, Premier Research
• Luke Gill, Executive Director Clinical Development Planning, Premier Research