Master Protocol Designs
ProOne protocol, multiple questions. Pick the right master-protocol design for your trial — basket, umbrella, or platform — and run it. Decision tree below.
Which design fits your trial?
Still unsure? The master-protocol guide has a full comparison table and worked examples.
Basket Trial
One treatment, multiple diseases
Single experimental therapy tested across multiple biomarker-defined indications. Independent per-basket analysis, BHM (Berry et al.), or EXNEX (Neuenschwander et al.) information borrowing across baskets.
Umbrella Trial
One disease, multiple biomarker-defined treatments
Multiple sub-studies testing different treatments within one disease against a shared control. Frequentist or Bayesian analysis with Bonferroni / Holm multiplicity correction; binary, continuous, and survival endpoints.
Platform Trial
One disease, multiple treatments added/dropped over time
Multi-arm multi-stage (MAMS) design with staggered arm entry/exit, shared control with non-concurrent adjustment (concurrent-only, pooled-adjusted, pooled-naive), alpha-spending boundaries (O'Brien-Fleming, Pocock).