1. Food Drug Administration Center for Drug Evaluation Research . Expansion cohorts: use in first-in-human clinical trials to expedite development of oncology drugs and biologics guidance for industry, https://www.fda.gov/media/115172/download (2018, accessed 1 May 2021).
Google Scholar2. Xin Yu, J, Hubbard-Lucey, VM, Tang, J. Immuno-oncology drug development goes global. Nat Rev Drug Discov 2019; 18(12): 899–900.
Google Scholar | Crossref | Medline3. Tang, J, Shalabi, A, Hubbard-Lucey, VM. Comprehensive analysis of the clinical immune-oncology landscape. Ann Oncol 2018; 29(1): 84–91.
Google Scholar | Crossref | Medline4. Kang, SP, Gergich, K, Lubiniecki, GM, et al. Pembrolizumab KEYNOTE-001: an adaptive study leading to accelerated approval for two indications and a companion diagnostic. Ann Oncol 2017; 28(6): 1388–1398.
Google Scholar | Crossref | Medline5. Beckman, RA, Clark, J, Chen, C. Integrating predictive biomarkers and classifiers into oncology clinical development programmes. Nat Rev Drug Discov 2011; 10(10): 735–748.
Google Scholar | Crossref | Medline6. Thall, PF, Wathen, JK, Bekele, BN, et al. Hierarchical Bayesian approaches to phase II trials in diseases with multiple subtypes. Stat Med 2003; 22(5): 763–780.
Google Scholar | Crossref | Medline | ISI7. Berry, SM, Broglio, KR, Groshen, S, et al. Bayesian hierarchical modeling of patient subpopulations: efficient designs of phase II oncology clinical trials. Clin Trials 2013; 10(5): 720–734.
Google Scholar | SAGE Journals | ISI8. Simon, R, Geyer, S, Subramanian, J, et al. The Bayesian basket design for genomic variant-driven phase II trials. Semin Oncol 2016; 43(1): 13–18.
Google Scholar | Crossref | Medline9. Zhou, H, Liu, F, Wu, C, et al. Optimal two-stage designs for exploratory basket trials. Contemp Clin Trials 2019; 85: 105807.
Google Scholar | Crossref | Medline10. Chen, C, Li, X, Yuan, S, et al. Statistical design and considerations of a phase 3 basket trial for simultaneous investigation of multiple tumor types in one study. Stat Biopharm Res 2016; 8(3): 248–257.
Google Scholar | Crossref11. Chen, C, Deng, Q, He, L, et al. How many tumor indications should be initially screened in development of next generation immunotherapies. Contemp Clin Trials 2017; 59: 113–117.
Google Scholar | Crossref | Medline12. Hong, Y. On computing the distribution function for the sum of independent and non-identical random indicators. Virginia Tech 2011, https://vtechworks.lib.Vt.edu/handle/10919/89411 (2011, accessed 1 May 2021).
Google Scholar13. Food Drug Administration Center for Drug Evaluation Research . Master protocols: efficient clinical trial design strategies to expedite development of oncology drugs and biologics, https://www.fda.gov/media/120721/download (2018, accessed 1 May 2021).
Google Scholar14. Neuenschwander, B, Wandel, S, Roychoudhury, S, et al. Robust exchangeability designs for early phase clinical trials with multiple strata. Pharm Stat 216; 15(2): 123–134.
Google Scholar | Crossref15. Hobbs, BP, Landin, R. Bayesian basket trial design with exchangeability monitoring. Stat Med 2018; 37(25): 3557–3572.
Google Scholar | Crossref | Medline16. Cunanan, KM, Iasonos, A, Shen, R, et al. An efficient basket trial design. Stat Med 2017; 36(10): 1568–1579.
Google Scholar | Medline17. Wu, X, Wu, C, Liu, F, Zhou, H, Chen, C. A Generalized Framework of Optimal Two-stage Designs for Exploratory Basket Trials. Statistics in Biopharmaceutical Research. 2021 Mar 23(just-accepted):1–2.
Google Scholar18. Chen, C, Anderson, K, Mehrotra, DV, et al. A 2-in-1 adaptive phase 2/3 design for expedited oncology drug development. Contemp Clin Trials 2018; 64: 238–242.
Google Scholar | Crossref | Medline