- Working Group Publications:
o Rong Liu, Ying Yuan, Qi Jiang, Xiaoyun (Nicole) Li, Chengxing (Cindy) Lu, Olga Marchenko, Suman Sen, Hong Tian, Heng Zhou, Ruitao Lin (2024). “Design Strategy and Consideration for Oncology Dose-Optimization: An Industry Perspective”, Statistics in Biopharmaceutical Research (accepted for publication).
o Jingjing Ye, Haitao Pan, Gregory Reaman, Satrajit Roychoudhury, Chengxing Lu, Lindsay A. Renfro, Yuan Ji, Rong Liu, Ying Yuan, Weidong Zhang (2024). “Considerations on Design and Analysis of External Control in Pediatric Oncology”, European Society of Medicine Archives, Vol 12 No 1 January issue Research Articles. DOI: https://doi.org/10.18103/mra.v12i1.5088
o Chen J, Li XN, Lu CC, Yuan S, Yung G, Ye J, Tian H, Lin J (2024). Considerations for master protocols using external controls. J Biopharm Stat. Feb, 16:1-23. doi: 10.1080/10543406.2024.2311248. Epub ahead of print. PMID: 38363805.
o Lu, C., Beckman, R., Li, X., Zhang, W., Jiang, Q., Marchenko, O., Sun, Z., Tian, H., Ye, J., Yuan S. (2024).Tumor-Agnostic Approvals: Insights and Practical Considerations. Clinical Cancer Research, 30(3):480-488. https://doi.org/10.1158/1078-0432.CCR-23-1340
o Ro, S.K., Zhang, W., Jiang, Q., Li, N., Liu, R., Lu, C., Marchenko, O., Sun, L. & Zhao, J. (2023). Statistical Considerations on the Use of RWD/RWE for Oncology Drug Approvals: Overview and Lessons Learned. Ther Innov Regul Sci., Volume 57, pp.899-910. https://doi.org/10.1007/s43441-023-00528-y
o Rong Liu, Ying Yuan, Suman Sen, Xin Yang, Qi Jiang, Xiaoyun (Nicole) Li, Chengxing (Cindy) Lu, Mithat Gönen, Hong Tian, Heng Zhou, Ruitao Lin & Olga Marchenko (2022). “Accuracy and Safety of Novel Designs for Phase I Drug-Combination Oncology Trials”, Statistics in Biopharmaceutical Research, Vol.14 (3): pp. 270-282, https://www.tandfonline.com/doi/full/10.1080/19466315.2022.2081602
o Weidong Zhang, Sunhee Ro, Qi Jiang, Xiaoyun Li, Rong Liu, Chengxing Lu, Olga Marchenko, Jing Zhao, Zhenzhen Xu (2022). “Statistical and Operational Considerations for 2-Stage Adaptive Designs with Simultaneous Evaluation of Overall and Marker-Selected Populations in Oncology Confirmatory Trials”, Therapeutic Innovation & Regulatory Science, Vol.56, pp.552-560, https://doi.org/10.1007/s43441-022-00407-y
o Xiaoyun Li, Chengxing Lu, Kristine Broglio, Paul Bycott, Jie Chen, Qi Jiang, Jianchang Lin, Jingjing Ye, Jun Yin (2022). “Current usage and challenges of master protocols—based on survey results by ASA BIOP oncology methodology working group master protocol sub-team”, Ann Translational Med, 10(18):1036. https://dx.doi.org/10.21037/atm-21-6139
o Chengxing (Cindy) Lu, Xiaoyun (Nicole) Li, Kristine Broglio, Paul Bycott, Qi Jiang, Xiaoming Li, Anna McGlothlin, Hong Tian, Jingjing Ye (2021). Practical Considerations and Recommendations for Master Protocol Framework: Basket, Umbrella and Platform Trials. Therapeutic Innovation and Regulatory Science, 55:1145-54.
- Publications Under Project SignifiCanT:
o Rajeshwari Sridhara, Olga Marchenko, Qi Jiang, Elizabeth Barksdale, Marc Theoret, Richard Pazdur (2024). “Collaboration under Project SignifiCanT”, Biopharmaceutical Report, Spring Issue, Volume 31 (1), pp. 10-11. https://community.amstat.org/biop/biopharmreport
o Rajeshwari Sridhara, Olga Marchenko, Qi Jiang, Elizabeth Barksdale, Nicole Li, Marc Theoret (2024). “Summary of ASA BIOP Section’s Virtual Discussion with Regulators on Design Considerations in the Evaluation of Contribution of Effect of Combination of Two New Investigational Drugs in Randomized Cancer Clinical Trials”, Biopharmaceutical Report, Spring Issue, Volume 31 (1), pp. 58-60. https://community.amstat.org/biop/biopharmreport
o Rajeshwari Sridhara, Olga Marchenko, Qi Jiang, Elizabeth Barksdale, Yiyi Chen, Marc Theoret (2023). “Summary of ASA BIOP Section’s Virtual Discussion with Regulators on Cancer Clinical Trial Design and Analysis Considerations in Evaluating Treatment Effect in Marker Negative Population – Part 2”, Biopharmaceutical Report, Fall Issue, Volume 30 (3), pp. 52-54. https://community.amstat.org/biop/biopharmreport
o Rajeshwari Sridhara, Olga Marchenko, Qi Jiang, Elizabeth Barksdale, Yiyi Chen, Marc Theoret (2023). “Summary of ASA BIOP Section’s Virtual Discussion with Regulators on Consideration of Criteria for Evaluation of Surrogate Endpoints”, Biopharmaceutical Report, Fall Issue, Volume 30 (3), pp. 49-51.
https://community.amstat.org/biop/biopharmreport
o Rajeshwari Sridhara, Olga Marchenko, Qi Jiang, Elizabeth Barksdale, Yiyi Chen, Marc Theoret (2023). “Summary of ASA BIOP Section’s Virtual Discussion with Regulators on Statistical Considerations in the Early Interim Overall Survival Analysis in Indolent Cancers for Evaluation of Risk”, Biopharmaceutical Report, Summer Issue, Volume 30 (2), pp. 57-59. https://community.amstat.org/biop/biopharmreport
o Rajeshwari Sridhara, Olga Marchenko, Qi Jiang, Elizabeth Barksdale, Yiyi Chen, Marc Theoret (2023). “Summary of ASA BIOP Section’s Virtual Discussion with Regulators on Non-inferiority Cancer Clinical Trial Design Considerations when Data from a Single Foreign Country is Available”, Biopharmaceutical Report, Summer Issue, Volume 30 (2), pp. 60-61. https://community.amstat.org/biop/biopharmreport
o Rajeshwari Sridhara, Olga Marchenko, Qi Jiang, Elizabeth Barksdale, Yiyi Chen, Marc Theoret (2023).“ Summary of ASA BIOP Section’s Virtual Discussion with Regulators on Considerations of Innovative Cancer Clinical Trial Designs for Post-Market Dose-Optimization Studies”, Biopharmaceutical Report, Summer Issue, Volume 30 (2), pp. 62-64. https://community.amstat.org/biop/biopharmreport
o Rajeshwari Sridhara, Olga Marchenko, Qi Jiang, Elizabeth Barksdale, Yiyi Chen, Paul Kluetz (2023). “Summary of ASA BIOP Section’s Virtual Discussion with Regulators on Assessing Bias in Cancer Studies with Real-World Data Elements”, Biopharmaceutical Report, Summer Issue, Volume 30 (2), pp. 55-56.
https://community.amstat.org/biop/biopharmreport
o Rajeshwari Sridhara, Olga Marchenko, Qi Jiang, Elizabeth Barksdale, Marc Theoret (2023). “ Summary of ASA BIOP Section’s Virtual Discussion with Regulators on Considerations in the Evaluation of Progression-free Survival with Informative Censoring in Cancer Clinical Trials”, Biopharmaceutical Report, Spring Issue, Volume 30 (1), pp. 52-54.
https://community.amstat.org/biop/biopharmreport
o Rajeshwari Sridhara, Olga Marchenko, Qi Jiang, Elizabeth Barksdale, Marc Theoret (2023). “Summary of ASA BIOP Section’s Virtual Discussion with Regulators on Consideration in the Evaluation and Interpretation of Interim Overall Survival Results from Randomized Cancer Clinical Trials in Chronic Diseases”, Biopharmaceutical Report, Spring Issue, Volume 30 (1), pp. 49-51.
https://community.amstat.org/biop/biopharmreport
o Olga Marchenko, Rajeshwari Sridhara, Qi Jiang, Elizabeth Barksdale, Richard Pazdur, Marc Theoret (2023). “Summary of ASA BIOP Section’s Virtual Discussion with Regulators on Impact on Type I Error with Unplanned Analyses in Cancer Clinical Trials”, Biopharmaceutical Report, Spring Issue, Volume 30 (1), pp. 46-48.
https://community.amstat.org/biop/biopharmreport
o Qi Jiang, Rajeshwari Sridhara, Olga Marchenko, Elizabeth Barksdale, Marc Theoret, Richard Pazdur (2023). “Summary of ASA BIOP Section’s Virtual Discussion with Regulators on Cancer Clinical Trial Design Considerations in Evaluating Treatment Effect in Marker Negative Population”, Biopharmaceutical Report, Spring Issue, Volume 30 (1), pp. 43-45. https://community.amstat.org/biop/biopharmreport
o Elizabeth Barksdale, Rajeshwari Sridhara, Olga Marchenko, Qi Jiang, Richard Pazdur (2023). “Summary of ASA BIOP Section’s Virtual Discussion with Regulators on Cancer Clinical Trial Design Considerations when Accepting Foreign Data from a Single Country”, Biopharmaceutical Report, Spring Issue, Volume 30 (1), pp. 40-42.
https://community.amstat.org/biop/biopharmreport
o Rajeshwari Sridhara, Olga Marchenko, Qi Jiang, Elizabeth Barksdale, Todd Alonzo, Anup Amatya, David Arons, Alex Bliu, Qiuyi Choo, Michael Coory,
Martha Donoghue, Lori Ehrlich, Leonardo Fabio Costa Filho, Elizabeth Fox,
Boris Freidlin, Nancy Goodman, Douglas S. Hawkins, Dieter A. Häring, Dominik Karres,
E. Anders Kolb, Helen Mao, Pallavi S. Mishra Kalyani, Arlene Naranjo, Alberto Pappo,
Martin Posch, Karen Price, Andrew Raven, KhadijaRerhou Rantell, Lindsay Renfro, Donna R. Rivera, Pourab Roy, Minghua Shan, Richard Simon, Sonia Singh, Malcolm Smith, Marc
Theoret, Marius Thomas, Zachary Thomas, Andrew Thompson, Hong Tian, Yevgen
Tymofyeyev, Jonathon Vallejo, Kyle Wathen, Jingjing Ye, Richard Pazdur & Gregory Reaman (2023). Statistical Considerations in Pediatric Cancer Trials: Report of American Statistical Association Biopharmaceutical Section Open Forum Discussions, Statistics in Biopharmaceutical Research, 15:4, 845-851, DOI: 10.1080/19466315.2023.2238650
https://www.tandfonline.com/doi/full/10.1080/19466315.2023.2238650
o Olga Marchenko, Rajeshwari Sridhara, Qi Jiang, Elizabeth Barksdale, Yuki Ando, Dinesh De Alwis, Katie Brown, Laura Fernandes, Mark T. J. van Bussel, Qiuyi Choo, Michael Coory, Elizabeth Garrett-Mayer, Thomas Gwise, Lorenzo Hess, Rong Liu, Sumithra Mandrekar, Daniele Ouellet, José Pinheiro, Martin Posch, Nam Atiqur Rahman, Khadija Rerhou Rantell, Andrew Raven, Sarem Sarem, Suman Sen, Mirat Shah, Yuan Li Shen, Richard Simon, Marc Theoret, Ying Yuan & Richard Pazdur (2023) “Designing Dose-Optimization Studies in Cancer Drug Development: Discussions with Regulators.” Statistics in Biopharmaceutical Research, 15:3, 697 -703, DOI: 10.1080/19466315.2023.2166099
https://www.tandfonline.com/doi/full/10.1080/19466315.2023.2166099
o Rajeshwari Sridhara, Elizabeth Barksdale, Olga Marchenko, Qi Jiang, Yuki Ando, Erick Bloomquist, Michael Coory, Melissa Crouse, Evgeny Degtyarev, Theodor Framke, Boris Freidlin, David E. Gerber, Thomas Gwise, Filip Josephson, Lorenzo Hess, Paul Kluetz, Daniel Li, Sumithra Mandrekar, Martin Posch, Khadija Rantell, Bohdana Ratitch, Andrew Raven, Kit Roes, Kaspar Rufibach, Sinan B. Sarac, Richard Simon, Harpreet Singh, Marc Theoret, Andrew Thomson, Emmanuel Zuber, Yuan Li Shen & Richard Pazdur (2023). ”Cancer Clinical Trials Beyond Pandemic: Report of an American Statistical Association Biopharmaceutical Section Open Forum Discussion”. Statistics in Biopharmaceutical Research, 15:2, 444-449, DOI: 10.1080/19466315.2022.2103181 https://www.tandfonline.com/doi/full/10.1080/19466315.2022.2103181
o Olga Marchenko, Rajeshwari Sridhara, Qi Jiang, Elizabeth Barksdale, Richard Pazdur, Marc Theoret (2022). “Summary of ASA BIOP Section’s Virtual Discussion with Regulators on Considerations for Data Monitoring Committee and Regulator Direct Interactions in Ongoing Randomized Cancer Clinical Trials”. Biopharmaceutical Report, Vol. 20, No. 3, Fall Issue, pp. 47 -49.
https://community.amstat.org/biop/biopharmreport
o Rajeshwari Sridhara, Olga Marchenko, Qi Jiang, Elizabeth Barksdale, Richard Pazdur, Gregory Reaman (2022). “Summary of ASA BIOP Section’s Virtual Discussion with Regulators on Consideration of Bayesian Approaches in Pediatric Cancer Clinical Trials”. Biopharmaceutical Report, Vol. 20 (3), Fall Issue, pp.45-46.
https://community.amstat.org/biop/biopharmreport
o Rajeshwari Sridhara, Olga Marchenko, Qi Jiang, Elizabeth Barksdale, Jie Chen, Nancy Dreyer, Lola Fashoyin-Aje, Elizabeth Garrett-Mayer, Nicole Gormley, Dr. Thomas Gwise, Lorenzo Hess, Sumithra Mandrekar, Francesco Pignatti, Khadija Rantell, Andrew Raven, Yuan-Li Shen, Harpreet Singh, Craig L. Tendler, Marc Theoret & Richard Pazdur (2022). ”Evaluation of Treatment Effect in Underrepresented Population in Cancer Trials: Discussion with International Regulators”. Statistics in Biopharmaceutical Research, 15:2, 450-456, DOI: 10.1080/19466315.2022.2128404
https://www.tandfonline.com/doi/full/10.1080/19466315.2022.2128404
o Sridhara, R., Marchenko, O., Jiang, Q., Barksdale, E., Pazdur, R., and Theoret, M. (2022), “Summary of ASA BIOP Section’s Virtual Discussion with Regulators on Time-to-event Endpoints in Cancer Trials in the Presence of Non-Proportional Hazards”, Biopharmaceutical Report, Spring Issue, Volume 22 (2), pp. 42-44.
https://community.amstat.org/biop/biopharmreport
o Sridhara, R., Marchenko, O., Jiang, Q., Barksdale, E., Pazdur, R., and Reaman, G. (2022). “Summary of American Statistical Association Biopharmaceutical Section’s Virtual Discussions with Regulators on Statistical Considerations in Clinical Trials for Rare Pediatric Cancers”, Biopharmaceutical Report, Spring Issue, Volume 29 (1), pp. 30 - 32.
https://community.amstat.org/biop/biopharmreport
o Rajeshwari Sridhara, Olga Marchenko, Qi Jiang, Richard Pazdur, Martin Posch, Scott
Berry, Marc Theoret, YuanLi Shen, Thomas Gwise, Lorenzo Hess, Andrew Raven, Khadija Rantell, Kit Roes, Richard Simon, Mary Redman, Yuan Ji & Cindy Lu (2022). Use of Nonconcurrent Common Control in Master Protocols in Oncology Trials: Report of an American Statistical Association Biopharmaceutical Section Open Forum Discussion, Statistics in Biopharmaceutical Research, 14:3, 353 357, DOI: 10.1080/19466315.2021.1938204
https://doi.org/10.1080/19466315.2021.1938204
o Rajeshwari Sridhara, Olga Marchenko, Qi Jiang, Richard Pazdur, Martin Posch, Mary Redman, Yevgen Tymofyeyev, Xiaoyun(Nicole) Li, Marc Theoret, YuanLi Shen, Thomas Gwise, Lorenzo Hess, Michael Coory, Andrew Raven, Naoto Kotani, Kit Roes, Filip Josephson,
Scott Berry, Richard Simon & Bruce Binkowitz (2022). Type I Error Considerations in Master Protocols With Common Control in Oncology Trials: Report of an American Statistical Association Biopharmaceutical Section Open Forum Discussion, Statistics in Biopharmaceutical Research, 14:3, 349-352, DOI: 10.1080/19466315.2021.1906743
https://doi.org/10.1080/19466315.2021.1906743
o Marchenko, O., Sridhara, R., Jiang, Q., Barksdale, E., and Pazdur, R. (2021), “Summary of ASA Virtual Discussion with Regulators on Designing Dose-Optimization Studies in Cancer Drug Development”, Biopharmaceutical Report, Fall Issue, Volume 28 (4), pp. 16-20. https://community.amstat.org/biop/biopharmreport
o Sridhara, R., Marchenko, O., Jiang, Q., Barksdale, E., and Pazdur, R. (2021), “Summary of American Statistical Association Biopharmaceutical Section’s Virtual Discussion with Regulators on Evaluation of Treatment Effect in Underrepresented Population in Oncology Clinical Trials”, Biopharmaceutical Report, Summer Issue, Volume 28 (3), pp. 28-30. https://community.amstat.org/biop/biopharmreport
o Marchenko, O., Sridhara, R., Jiang, Q., Barksdale, E., and Pazdur, R. (2021), “Summary of ASA Virtual Discussion with Regulators on Designing Dose-Optimization Studies in Cancer Drug Development”, Biopharmaceutical Report, Summer Issue, Volume 28 (3), pp. 26-27. https://community.amstat.org/biop/biopharmreport
o Barksdale, E., Sridhara, R., Marchenko, O., Jiang, Q., and Pazdur, R. (2021), “Summary of American Statistical Association Biopharmaceutical Section’s Virtual Discussion with Regulators on Statistical Considerations in Oncology Trials in the COVID-19 Era”, Biopharmaceutical Report, Summer Issue, Volume 28 (3), pp. 23-25.
https://community.amstat.org/biop/biopharmreport
o Sridhara, R., Marchenko, O., Jiang, Q., and Pazdur, R. (2021), “Use of Non-Concurrent Common Control for Treatment Comparisons in Master Protocols”, Biopharmaceutical Report, Winter Issue, Volume 28 (1), pp. 12–14.
https://community.amstat.org/biop/biopharmreport
o Sridhara R, Marchenko O, Jiang Q, Binkowitz B (2020). “Summary of American Association Biopharmaceutical Section’s Virtual Discussion with Regulators on Type I error Considerations in Master Protocols with Common Control in Oncology Clinical Trials”, Biopharmaceutical Report, Fall Issue, Volume 27 (3), pp. 39-40. https://community.amstat.org/biop/biopharmreport