Basket trials have associated methodological, operational, and regulatory considerations within immune-mediated disorders. Strategic positioning of shared biomarkers and overlaps in disease mechanisms can accelerate clinical development by reducing the time to signal detection and optimizing pooled resources through basket trials. However, these trials are associated with potential pitfalls. When properly implemented, basket trials are an effective translational tool that unites discovery and proof of concept.
Read our white paper to learn more about:
- How analytical complexity, potential limited clinical inference due to small cohorts, and variable regulatory expectations across respective reviewing divisions all impact prospective benefits
- The role for strong mechanistic justification, predefined borrowing and multiplicity strategies, early agency engagement, and a robust operational infrastructure in avoiding potential hazards to success
- Managing diverse regulatory agencies’ expectations to position your novel drug for approval
