Publications

Research Papers

  1. Sverdlov, O., Renteria, J., Carter, K., Scheffold, A. L., Krisam, J., Mascheroni, P. & Seidel, J. (2025). To what extent is response-adaptive randomization used in clinical trials? A systematic review using Cortellis Regulatory Intelligence database. Statistical Methods in Medical Research. https://doi.org/10.1177/09622802251354924
  2. Mukherjee, A., Sverdlov, O., Ha, N.-T., & Deng, Y. (2025). Estimands for randomized discontinuation designs in oncology. Preprint. https://doi.org/10.48550/arXiv.2506.00556
  3. 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
  4. Zhao, W., & Livingston, S. (2025), Allocation Predictability of Individual Assignments in Restricted Randomization Designs for Two-Arm Equal Allocation Trials. Statistics in Medicine, 44: e10343. https://doi.org/10.1002/sim.10343
  5. Pin, L., Sverdlov, O., Bretz, F. & Bornkamp, B. (2025), Randomization-Based Inference for MCP-Mod. Statistics in Medicine, 44: e70092. https://doi.org/10.1002/sim.70092
  6. 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
  7. Mukherjee, A., J. L. Moscovici, & Z. Liu. 2025. “ Estimands for Early-Phase Dose Optimization Trials in Oncology.” Biometrical Journal 67(5), e70072. https://doi.org/10.1002/bimj.70072
  8. Kuznetsova, O., Ross, J., Bodden, D., Cooner, F., Chipman, J., Jacko, P., Krisam, J., Luo, Y. A., Mielke, T., Robertson, D. S., Ryeznik, Y., Villar, S. S., Zhao, W., & Sverdlov, O. (2025). Randomization in the age of platform trials: unexplored challenges and some potential solutions. BMC Med Res Methodol, 25(268). https://doi.org/10.1186/s12874-025-02693-0
  9. 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
  10. 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)
  11. 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
  12. 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
  13. 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
  14. 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
  15. 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
  16. 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
  17. 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
  18. 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
  19. 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
  20. 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
  21. 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
  22. Zhao, W., Yeatts, S. D., Broderick, J. P., Selim, M. H., Adeoye, O. M., Durkalski-Mauldin, V. L., Meinzer, C. N., Martin, R. H., Dillon, C. R., Cassarly, C. N., Pauls, K. H., & Elm, J. J. (2023). Optimal Randomization Designs for Large Multicenter Clinical Trials: From the National Institutes of Health Stroke Trials Network Funded by National Institutes of Health/National Institute of Neurological Disorders and Stroke Experience. Stroke, 54(7), 1909–1919. https://doi.org/10.1161/strokeaha.122.040743
  23. 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

Contributed responses

  1. CONSORT: Berger, V. W., Carter, K., Jacko, P., Krisam, J., Kuznetsova, O. M., Luo, Y. A., Mukherjee, A., Pin, L., Scheffold, A. L., Sverdlov, O., Villar, S. S., Zhao, W. (2025). Perspective of members of the Randomization WG: Response to “CONSORT 2025 statement: Updated guideline for reporting randomised trials.” BMJ, 389, e081123. https://www.bmj.com/content/389/bmj-2024-081123/rr-3
  2. ICH E20: Berger, V. W., Carter, K., Jacko, P., Krisam, J., Mukherjee, A., Pin, L., Robertson, D. S., Sverdlov, O., Uschner, D., Villar, S. S., Zhao, W. (2025). Comments on ICH E20 Draft Guidance: Adaptive designs for clinical trials [Public comment]. U.S. Food and Drug Administration. https://www.regulations.gov/comment/FDA-2025-D-3023-0011

Skip to toolbar