Master Protocols
Master Protocols
Basket, Umbrella, and Platform studies: greater flexibility to evaluate more than one or two treatments in more than one patient type or disease.
GUIDANCES
ARTICLES
Pestana RC, Sen S, Hobbs BP, and Hong Histology-agnostic drug development — considering issues beyond the tissue Nature Reviews, Clinical Oncology (2020)
Sudop T, et. al. Master protocols in clinical trials: a universal Swiss Army knife? The Lancet Oncology 20.2 (2019): PE336-E342.
Burd A, et. al. Challenges and approaches to implementing master/basket trials in oncology. Blood Advances 3.14 (2019): 2237–2243.
Kaizer AM, et. al. Basket Designs: Statistical Considerations for Oncology Trials. JCO Precision Oncology 3 (2019): 1-9
Qin, BD et al. Basket Trials for Intractable Cancer. Frontiers in Oncology 9.229 (2019).
Hobbs BP, Chen N, Lee JJ. Controlled multi-arm platform design using predictive probability. Statistical Methods in Medical Research 27.1 (2018): 65-78.
Hobbs BP & Landin R. Bayesian basket trial design with exchangeability monitoring. Statistics in Medicine 37.25 (2018): 3357-3572.
Hobbs BP, et. al. Statistical challenges posed by uncontrolled master protocols: sensitivity analysis of the vemurafenib study. Annals of Oncology 29.12 (2018): 2296-2301.
Chu Y & Yuan Y. A Bayesian basket trial design using a calibrated Bayesian hierarchical model. Clinical Trials 15.2 (2018): 149-158.
Kaiser MA, Koopmeiners JS, & Hobbs BP. Bayesian hierarchical modeling based on multisource exchangeability. Biostatistics 19.2 (2018): 169-184.
Simon, R. New designs for basket clinical trials in oncology. Journal of Biopharmaceutical Statistics 28.2 (2018): 245-255.
Woodcock J & LaVange LM. Master Protocols to Study Multiple Therapies, Multiple Diseases, or Both. The New England Journal of Medicine 377 (2017) 62-70.
Cunanan KM, et. al. An efficient basket trial design. Statistics in Medicine 36.10 (2017): 1568-1579
Simon R, et. al. The Bayesian basket design for genomic variant-driven phase II trials. Seminars in Oncology 43.1 (2016): 13-18.
Chen, C. et al. Statistical Design and Considerations of a Phase 3 Basket Trial for Simultaneous Investigation of Multiple Tumor Types in One Study. Statistics in Biopharmaceutical Research 8.3 (2016): 248-257.
Redig AJ & Jänne PA. Basket Trials and the Evolution of Clinical Trial Design in an Era of Genomic Medicine. Journal of Clinical Oncology 33.9 (2015): 975-977.
Beckman RA, et. al. Adaptive Design for a Confirmatory Basket Trial in Multiple Tumor Types Based on a Putative Predictive Biomarker. Clinical Pharmacology and Therapeutics 100.6 (2016): 617-625.
Analyzing Basket Trials under Multisource Exchangeability Assumptions. COMING SOON…
Histology- agnostic drug development: what are the issues beyond the tissue? COMING SOON…
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FDA Officials: Master Protocols Needed for Precision Medicine
