Umbrella, Basket, and Platform Trials: What Oncology Has Learned From New Biomarker-Driven Designs
This critical review examines novel clinical trial designs · umbrella, basket, and platform trials · developed for biomarker-driven cancer drug development alongside companion diagnostics. By analyzing completed trials using these frameworks, the author clarifies which objectives each design serves and where they have succeeded or fallen short. The review is essential reading for laboratories involved in companion diagnostic development, as trial architecture directly shapes biomarker validation requirements.
The original study
Critical Review of Umbrella, Basket, and Platform Designs for Oncology Clinical Trials.
- Authors
- Simon R
- Journal
- Clinical pharmacology and therapeutics
- Type
- Journal Article, Review
- PMID
- 28795401
Original abstract
The successful development of new drugs with a companion diagnostic based on genomic alteration of an oncogene has led to rethinking of all phases on clinical development of cancer drugs. We critically review some of the new clinical trial designs for biomarker-based cancer drug development. We try to clarify the objectives of the new designs and examine completed trials using these designs to evaluate what has been learned about these designs.