Designing Post-Trial Access Strategies Before the First Patient Enrolls

  • Embedding post-trial access planning into clinical trial design to avoid last-minute ethical and operational dilemmas
  • Evaluating when post-trial access, long-term extensions, or hybrid approaches make the most sense by disease, geography, and duration
  • Anticipating regulatory constraints that may prevent post-trial access in certain countries and adjusting trial footprints accordingly
  • Aligning clinical development, medical affairs, and access teams early to support continuity of care