Challenges in Oncology Clinical Trial Design

Table of Contents

• Executive Summary
  • Strategic Considerations
  • Stakeholder Implications
• Introduction
• Background on Oncology Clinical Trials
  • Changes in Cancer Treatment and FDA Guidelines
  • Current End Points
    • Survival
    • Response Rate in Solid Tumors
    • Time to Progression
    • Composite Clinical Benefi t End Points
    • Quality of Life
• Challenges in Oncology Clinical Trials
  • Choosing Appropriate End Points and Managing Data Complexity
  • Randomization Design
  • Operational Challenges
  • Safety
  • Recruitment
• Case Studies
  • Novartis’s Gleevec
  • Genentech’s Tarceva
• Trends in Oncology Trials-Surrogate End Points and Biomarkers

Tables

• 1. Targeted Therapeutics Approved for the Treatment of Cancer
• 2. Commonly Used End Points in Oncology Clinical Trials
• 3. Response Evaluation Criteria in Solid Tumors (RECIST)
• 4. Select FDA-Approved Companion Diagnostics

Figures

• 1. Average Response Rates to “One-Size-Fits-All” Drugs