Bayesian variable selection on small sample trial data via adaptive posterior-informed shrinkage prior
Identifying variables associated with clinical endpoints is a central objective in clinical trials. With the rapid expansion of cell and gene therapies (CGTs) and therapeutics for ultra-rare diseases, there is an urgent demand for statistical methods capable of detecting meaningful associations under severe sample-size constraints. Motivated by data-borrowing strategies for historical controls, we propose the Adaptive Posterior-Informed Shrinkage Prior (APSP), a Bayesian framework that adaptively leverages external information to improve variable-selection efficiency while preserving robustness across diverse scenarios. APSP extends existing Bayesian borrowing methods by incorporating data-driven adaptive information selection, mixture shrinkage informative priors, and empirical-null-based decision rules, thereby enhancing variable-selection performance in small-sample settings. Extensive simulations demonstrated that APSP consistently matches or exceeds the efficiency of traditional and widely used Bayesian data-borrowing and variable-selection approaches. Notably, it exhibits strong robustness against possible discrepancies between internal and external data across a broad range of simulation scenarios. Finally, we applied APSP to the Clinical Islet Transplantation (CIT) Consortium, identifying variables associated with peak C-peptide at Day 75 in study CIT-06 by borrowing information from study CIT-07.
Authors
- Lingxuan Kong (ORCID: https://orcid.org/0000-0002-6425-6510)
- Yaoyuan Vincent Tan (ORCID: https://orcid.org/0000-0001-5950-9846)
- Chenkun Wang (ORCID: https://orcid.org/0000-0001-8271-4039)
- Yumin Zhang (ORCID: https://orcid.org/0000-0002-8093-7201)
Institutions
- University of Michigan (US)
- Vertex Pharmaceuticals (United States) (US)
Publication Details
- Journal
- Journal of Biopharmaceutical Statistics
- Published
- 2026-09-18
- DOI
- https://doi.org/10.1080/10543406.2026.2729801
- Primary Topic
- Statistical Methods in Clinical Trials
- Type
- article
- Field-Weighted Citation Impact
- 0.00