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    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.



     Master Protocols: Efficient Clinical Trial Design Strategies To Expedite Development of Oncology Drugs and Biologics.



    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 oncologyBlood 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 probabilityStatistical Methods in Medical Research 27.1 (2018): 65-78.

    Hobbs BP & Landin R.  Bayesian basket trial design with exchangeability monitoringStatistics 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 modelClinical 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 BothThe New England Journal of Medicine 377 (2017) 62-70.

    Cunanan KM, et. al.  An efficient basket trial designStatistics 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 StudyStatistics 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 MedicineJournal 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 BiomarkerClinical 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…



    FDA Officials: Master Protocols Needed for Precision Medicine


    Biomarker Driven Studies

    Statistical methods for establishing optimal treatment rules for matching patients to therapy.
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    Seamless Trial Designs

    Designs to consolidate the phases of drug development through rapid cohort expansion.
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    Short Course: Drug development of non-cytotoxics

    Half-day Shortcourse: Subtype Identification and Strategies for Trial Design.
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