Core 4: Innovative, Adaptive Clinical Trials

  • The goal is to test novel targeted treatments in innovative clinical trials to validate molecular marker based personalized therapy for GBM.
  • Advances in molecular biology and patient molecular profiling that may facilitate targeted therapy have provided a basis to improve clinical trial design. The Defeat collaborative is involved in an innovative public-private collaboration to implement a Global Adaptive Trial in GBM patients.
  • An adaptive “biomarker enriched” clinical trial of targeted therapies for patients with GBM will seek to identify molecular sub‐groups of GBM patients that show the best responses to treatments targeting specific mechanisms. This novel trial design will improve the efficiency of early clinical testing and increase the probability of success in late phase registration trials seeking drug approval.