Publications

Research Papers

  1. Sverdlov, O., Carter, K., Cassarly, C., Ryeznik, Y., & Berger, V. W. (2025). Maximum tolerated imbalance randomization: Theory and practice. In D. G. Chen (Ed.), Biostatistics in Biopharmaceutical Research and Development (pp. 289-311). Springer. https://doi.org/10.1007/978-3-031-65948-5
  2. Mukherjee, A., Jana, S., & Coad, S. (2024). Covariate-adjusted response-adaptive designs for semiparametric survival models. Statistical Methods in Medical Research. https://doi.org/10.1177/09622802241287704
  3. Mukherjee, A., & Sayantee, J. (2024). Covariate-Adjusted Response Adaptive Designs for Competing Risk Survival Models. Statistics in Biopharmaceutical Research, 1-38. https://doi.org/10.1080/19466315.2024.2446233
  4. Uschner, D., Sverdlov, O., Carter, K., Chipman, J. J., Kuznetsova, O., Renteria, J., Lane, A., Barker, C., Geller, N., Proschan, M., Posch, M., Tarima, S., Bretz, F., & Rosenberger, W. F. (2024). Using randomization tests to address disruptions in clinical trials: A report from the NISS Ingram Olkin forum series on unplanned clinical trial disruptions. Statistics in Biopharmaceutical Research, 16(4), 405-413. https://doi.org/10.1080/19466315.2023.2257894 (with Discussion and Rejoinder: https://doi.org/10.1080/19466315.2024.2394456)
  5. Carter, K., Scheffold, A. L., Renteria, J., Berger, V. W., Luo, Y. A., Chipman, J. J., & Sverdlov, O. (2024). Regulatory guidance on randomization and the use of randomization tests in clinical trials: A systematic review. Statistics in Biopharmaceutical Research, 16(4), 428-440. https://doi.org/10.1080/19466315.2023.2239521
  6. Sverdlov, O., Carter, K., Hilgers, R. D., Everett, C. C., Berger, V. W., Luo, Y. A., Chipman, J. J., Ryeznik, Y., Ross, J., Knight, R., & Yamada, K. (2024). Which randomization methods are used most frequently in clinical trials? Results of a survey by the Randomization Working Group. Statistics in Biopharmaceutical Research, 16(4), 441-455. https://doi.org/10.1080/19466315.2023.2225451
  7. Heussen, N., Hilgers, R. D., Rosenberger, W. F., Tian, X., & Uschner, D. (2024). Randomization-based inference for clinical trials with missing outcome data. Statistics in Biopharmaceutical Research, 16(4), 456-467. https://doi.org/10.1080/19466315.2023.2250119
  8. Johnson, V. P., Gekhtman, M., & Kuznetsova, O. M. (2024). Validity of tests for time-to-event endpoints in studies with the Pocock and Simon covariate-adaptive randomization. Statistics in Biopharmaceutical Research, 16(4), 468-482. https://doi.org/10.1080/19466315.2023.2261672
  9. Kuznetsova, O. M. (2024). Minimizing selection bias under the Blackwell and Hodges model with an equal allocation procedure in a symmetric allocation space. Statistics in Biopharmaceutical Research, 16(4), 483-490. https://doi.org/10.1080/19466315.2023.2208061
  10. Sverdlov, O., & Ryeznik, Y. (2024). Balancing the objectives of statistical efficiency and allocation randomness in randomized controlled trials. Statistics in Biopharmaceutical Research, 16(4), 532-546. https://doi.org/10.1080/19466315.2023.2261671
  11. Krisam, J., Ryeznik, Y., Carter, K., Kuznetsova, O. M., & Sverdlov, O. (2024). Understanding an impact of patient enrollment pattern on predictability of central (unstratified) randomization in a multi‐center clinical trial. Statistics in Medicine, 43(17), 3313-3325. https://doi.org/10.1002/sim.10117
  12. Carter, K., Kuznetsova, O., Anisimov, V., Krisam, J., Scherer, C., Ryeznik, Y., & Sverdlov, O. (2024). Forced randomization: The what, why, and how. BMC Medical Research Methodology, 24(234), 1-22. https://doi.org/10.1186/s12874-024-02340-0
  13. Zhao, W., Carter, K., Sverdlov, O., Scheffold, A., Ryeznik, Y., Cassarly, C., & Berger, V. W. (2024). Steady‐state statistical properties and implementation of randomization designs with maximum tolerated imbalance restriction for two‐arm equal allocation clinical trials. Statistics in Medicine, 43(6), 1194-1212. https://doi.org/10.1002/sim.10013
  14. Sverdlov, O., Ryeznik, Y., Anisimov, V., Kuznetsova, O. M., Knight, R., Carter, K., Drescher, S., & Zhao, W. (2024). Selecting a randomization method for a multi-center clinical trial with stochastic recruitment considerations. BMC Medical Research Methodology, 24(52), 1-23. https://doi.org/10.1186/s12874-023-02131-z
  15. Sverdlov, O., Berger, V. W., & Carter, K. (2024). On “Re‐randomization tests as sensitivity analyses to confirm immunological noninferiority of an investigational vaccine: Case study” by Luca Grassano et al. (2023, Pharmaceutical Statistics). Pharmaceutical Statistics, 23(3), 425-428. https://doi.org/10.1002/pst.2363
  16. Berger, V. W., Bour, L. J., Carter, K., Chipman, J. J., Everett, C. C., Heussen, N., & Randomization Innovative Design Scientific Working Group Robert A Beckman. (2021). A roadmap to using randomization in clinical trials. BMC Medical Research Methodology, 21, 1-24. https://doi.org/10.1186/s12874-021-01303-z

Software

  1. Ryeznik, Y., Sverdlov, O. “Incertus.jl—The Julia Lego Blocks for Randomized Clinical Trial Designs.” https://arxiv.org/pdf/2407.14248
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