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FDA-Industry Scientific Exchange on assessing quantitative systems pharmacology models in clinical drug development: a meeting report, summary of challenges/gaps, and future perspective
Jane P. F. Bai, Brian James Schmidt, Kapil G. Gadkar, Valeriu Damian, Justin C. Earp, Christina M. Friedrich, +6 more
39citations -
Recent criteria and simple rules agreed often on required sample size for developed clinical prediction models2026 Journal of Clinical Epidemiology article Mathematics Statistical Methods in Epidemiology Open access
Ewout Willem Steyerberg, Toby Hackmann, Ben Van Calster, Maarten van Smeden, Laure Wynants
0citations -
Multi-stakeholder sessions on major innovation topics in rare disease clinical trials2024 Orphanet Journal of Rare Diseases article Mathematics Statistical Methods in Clinical Trials Open access
Daniel Bodden, Stefanie Schoenen, Stephanie Wied, Johan Verbeeck, Maya Dirani, Nicole Maria Heussen, +3 more
3citations -
The Changing Face of Oncology Research, Drug Development, and Clinical Practice: Toward Patient‐Focused Precision Therapeutics2020 Clinical Pharmacology & Therapeutics article Mathematics Statistical Methods in Clinical Trials Open access
Karthik Venkatakrishnan, Piet H. van der Graaf, Sarah A. Holstein
4citations -
Lessons learnt when accounting for competing events in the external validation of time-to-event prognostic models2021 International Journal of Epidemiology article Mathematics Statistical Methods in Epidemiology Open access
Chava L. Ramspek, Lucy Teece, Kym I E Snell, Marie Evans, Richard D Riley, Maarten van Smeden, +2 more
45citations -
Which Randomization Methods Are Used Most Frequently in Clinical Trials? Results of a Survey by the Randomization Working Group2023 Statistics in Biopharmaceutical Research article Mathematics Statistical Methods in Clinical Trials Open access
Oleksandr Sverdlov, Kerstine Carter, R.-D Hilgers, Colin Charles Everett, Vance W. Berger, Yuqun Luo, +5 more
8citations -
Estimation of required sample size for external validation of risk models for binary outcomes2021 Statistical Methods in Medical Research article Mathematics Statistical Methods in Epidemiology Open access
Menelaos Pavlou, Qu Chen, Rumana Omar, Shaun R. Seaman, Ewout Willem Steyerberg, Ian R. White, +1 more
60citations -
The impact of allocation bias on test decisions in clinical trials with multiple endpoints using multiple testing strategies2024 BMC Medical Research Methodology article Mathematics Statistical Methods in Clinical Trials Open access
Stefanie Schoenen, Nicole Maria Heussen, Johan Verbeeck, R.-D Hilgers
6citations -
Pragmatic gynecologic cancer clinical trials: statements and roadmap from the Gynecologic Cancer InterGroup Chicago Brainstorming Meeting2026 International Journal of Gynecological Cancer article Mathematics Statistical Methods in Clinical Trials Open access
Ainhoa Madariaga, Ana Carolina Veneziani, Michael A. Bookman, Nicholas Counsell, Austin Miller, John Andrews, +24 more
0citations