Dahshu IDSWG Oncology

Community Service and Impact

Conference Sessions

  • Year 2025
    • ASA BIOP Regulatory-Industry Statistics Workshop 2025
      • Overcoming Obstacles in Using Hybrid Controls used as a Basis for Clinical Trials
  • Year 2024
    • JSM 2024
      • Examples and perspectives using ML and AI in drug development
    • ASA BIOP Regulatory-Industry Statistics Workshop 2024
      • Case Examples of Oncology Dose Optimization in Response to Project Optimus
  • Year 2023
    • Duke Industry Statistics Symposium (DISS) 2023
      • Data Integration in Multi-Stage Adaptive Design
      • Information Borrowing in Oncology Trials
    • JSM 2023
      • Statistical Consideration in Basket Trial Design
      • Seamless late-stage development in oncology – the past decade in practice. Joint Statistical Meeting, Toronto.
    • ASA BIOP Regulatory-Industry Statistics Workshop 2023
      • Gu et al. Getting the Dose Right: FDA’s Project Optimus in Practice
      • He P et al. Advancement of Study Designs, Endpoints, and Statistical Analyses in Clinical Trials for Rare Hematology/Oncology Disorders.
  • Year 2022
    • ASA BIOP Regulatory-Industry Statistics Workshop 2022
      • He P, Dong Y, Cindy L, and Cooner F. Getting “Real” with Master Protocol

WG Publications

  • Year 2025
    • Broglio L, Chen C, He P, Li X, Zhou H (2025). Book Chapter: Exploratory Basket Trials. Springer.
    • He P, Ma H, Lu C, Ananthakrishnan R, Mi G, Gwise T, Fernandes L, Yang H, Leung D, Ren N, Chaudhry S (2025). Ensuring Quality and Interpretability of Progression Free Survival and Overall Survival in Oncology Clinical Trials. Therapeutic Innovation and Regulatory Science. doi:10.1007/s43441-025-00848-1.
    • He P, Mi G, Zhang Z, Chakravartty A, Mitchell P, D’Angelo G, Ma H, Mishra K, Colin P. (2025). Book chapter: Oncology Dose Optimization Trials. Statistics in Clinical Development of Cancer Drugs: Recent Trends & Advances. Publisher: Springer Nature.
    • Cindy Lu, et al. (2025) Roadmap of master protocol implementation. Ther Innov Regul Sci.
  • Year 2024
    • A Systematic Review of Adaptive SeamlessClinical Trials for Late-Phase Oncology Development”, Ther Innov Regul Sci 58, 917–929 (2024). https://doi.org/10.1007/s43441-024-00670-1
    • Use of seamless study designs in Oncology Clinical Development – A survey conducted by IDSWG oncology sub-team. Ther Innov Regul Sci. 2024 Sep;58(5):978-986. doi:10.1007/s43441-024-00676-9. Epub 2024 Jun22.

Community Events

Presentations

  • Year 2025
    • He P, Fernandes L, Yu B (2025). Real-World Data and External Data to Accelerate Clinical Development. 5th ACE Clinical Trials Summit. Boston, MA. June, 2025.
    • Binbing Yu, Dai Feng, Laura Fernandes, Haijun Ma, Philip He, Arunava Chakravartty (2025). Choice of index date for an externally controlled arm in oncology trials for late line therapies. JSM. Nashville. August 2025.
    • He P, Dong C, Ma H, Lu C, Ananthakrishnan R, Mi G, Gwise T, Fernandes L, Zhou H, Yang H, Leung D, Lee C, Ren N, Chaudhry S (2025). Ensuring quality and interpretability of progression free survival and overall survival – E9(R1) estimand perspective. JSM. Nashville. August 2025.
    • Cindy Lu. Master protocol, ISBS, 2025
  • Year 2024
    • He P, Dong C*, Zhou H, Ayyala D, and Zhang Z (2024). A review and roadmap of statistical methodology for seamless phase 2/3 designs in oncology trials. Joint Statistical Meeting, 2024. Portland OR.
  • Year 2023
    • Dong Y., He, P. and et al (2023) Use of seamless study design for registration in oncology clinical development – An industry survey. Invited talk. Joint Statistical Meeting, Toronto.
    • Broglio K., Cooner F., He, P. and et al (2023) Adaptive seamless design in late-stage oncology development – A systemic meta-analysis of real clinical cases. Invited talk. Joint Statistical Meeting, Toronto.

Public Comments

Journal Special Issue

  • Recent Advances in Oncology Clinical Trials

IDSWG Oncology Newsletter