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Original Articles

Statistical Modeling of Clinical Trials (Recruitment and Randomization)

Pages 3684-3699 | Received 27 Jan 2011, Accepted 07 Feb 2011, Published online: 22 Aug 2011

Keep up to date with the latest research on this topic with citation updates for this article.

Read on this site (4)

Mitchell Aaron Schepps, Weng Kee Wong, Matt Austin & Volodymyr Anisimov. (2024) Optimizing Patient Recruitment in Global Clinical Trials using Nature-Inspired Metaheuristics. Statistics in Biopharmaceutical Research 0:0, pages 1-15.
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Vladimir Anisimov & Matthew Austin. (2020) Centralized statistical monitoring of clinical trial enrollment performance. Communications in Statistics: Case Studies, Data Analysis and Applications 6:4, pages 392-410.
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Dejian Lai, Qiang Zhang, Jose-Miguel Yamal, Paula T. Einhorn & Barry R. Davis. (2017) Conditional moving linear regression: Modeling the recruitment process for ALLHAT. Communications in Statistics - Theory and Methods 46:18, pages 8943-8951.
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Vladimir V. Anisimov. (2016) Predictive Hierarchic Modeling of Operational Characteristics in Clinical Trials. Communications in Statistics - Simulation and Computation 45:5, pages 1477-1488.
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Articles from other publishers (36)

Philip Heesen & Malgorzata Roos. (2024) Freely accessible software for recruitment prediction and recruitment monitoring of clinical trials: A systematic review. Contemporary Clinical Trials Communications 39, pages 101298.
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Sheng Zhong, Yunzhao Xing, Mengjia Yu & Li Wang. (2023) Enrollment forecast for clinical trials at the portfolio planning phase based on site‐level historical data. Pharmaceutical Statistics 23:2, pages 151-167.
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Oleksandr Sverdlov, Yevgen Ryeznik, Volodymyr Anisimov, Olga M. Kuznetsova, Ruth Knight, Kerstine Carter, Sonja Drescher & Wenle Zhao. (2024) Selecting a randomization method for a multi-center clinical trial with stochastic recruitment considerations. BMC Medical Research Methodology 24:1.
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Mengjia Yu, Sheng Zhong, Yunzhao Xing & Li Wang. (2023) Enrollment Forecast for Clinical Trials at the Planning Phase with Study-Level Historical Data. Therapeutic Innovation & Regulatory Science 58:1, pages 42-52.
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Virginia B. Shipes, Caitlyn Meinzer, Bethany J. Wolf, Hong Li, Mathew J. Carpenter, Hooman Kamel & Renee H. Martin. (2023) Designing a phase‐III time‐to‐event clinical trial using a modified sample size formula and Poisson‐Gamma model for subject accrual that accounts for the lag in site initiation using the PERT distribution . Statistics in Medicine 42:30, pages 5694-5707.
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Armando Turchetta, Nicolas Savy, David A. Stephens, Erica E.M. Moodie & Marina B. Klein. (2023) A time‐dependent Poisson‐Gamma model for recruitment forecasting in multicenter studies. Statistics in Medicine 42:23, pages 4193-4206.
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Volodymyr Anisimov. (2023) An Analytic Methodology for Forecasting Patient Enrolment Performance in Multicentre Clinical Trials: Forecasting Patient Enrolment Performance in Clinical Trials. An Analytic Methodology for Forecasting Patient Enrolment Performance in Multicentre Clinical Trials: Forecasting Patient Enrolment Performance in Clinical Trials.
Magda Amiridi, Cheng Qian, Nicholas D. Sidiropoulos & Lucas M. Glass. (2023) Enrollment Rate Prediction in Clinical Trials based on CDF Sketching and Tensor Factorization tools. Enrollment Rate Prediction in Clinical Trials based on CDF Sketching and Tensor Factorization tools.
. 2022. Data Analysis and Related Applications 2. Data Analysis and Related Applications 2 119 142 .
Li Wang, Yang Liu, Xiaotian Chen & Erik Pulkstenis. (2022) Real time monitoring and prediction of time to endpoint maturation in clinical trials. Statistics in Medicine 41:18, pages 3596-3611.
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Rachael Mountain & Chris Sherlock. (2021) Recruitment prediction for multicenter clinical trials based on a hierarchical Poisson–gamma model: Asymptotic analysis and improved intervals. Biometrics 78:2, pages 636-648.
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Cameron Bieganek, Constantin Aliferis & Sisi Ma. (2022) Prediction of clinical trial enrollment rates. PLOS ONE 17:2, pages e0263193.
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Vladimir Anisimov & Matthew Austin. 2022. Stochastic Processes, Statistical Methods, and Engineering Mathematics. Stochastic Processes, Statistical Methods, and Engineering Mathematics 511 540 .
Paul Aubel, Marine Antigny, Ronan Fougeray, Frédéric Dubois & Gaëlle Saint‐Hilary. (2021) A Bayesian approach for event predictions in clinical trials with time‐to‐event outcomes. Statistics in Medicine 40:28, pages 6344-6359.
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Ruan Spies, Nandi Siegfried, Bronwyn Myers & Sara S. Grobbelaar. (2021) Concept and development of an interactive tool for trial recruitment planning and management. Trials 22:1.
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Michael Lefew, Anh Ninh & Vladimir Anisimov. (2020) End-to-End Drug Supply Management in Multicenter Trials. Methodology and Computing in Applied Probability 23:3, pages 695-709.
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Ryunosuke Machida, Yosuke Fujii & Takashi Sozu. (2021) Predicting study duration in clinical trials with a time‐to‐event endpoint. Statistics in Medicine 40:10, pages 2413-2421.
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Mahesh Ramanan, Laurent Billot, Dorrilyn Rajbhandari, John Myburgh, Simon Finfer, Rinaldo Bellomo & Balasubramanian Venkatesh. (2020) Does asymmetry in patient recruitment in large critical care trials follow the Pareto principle?. Trials 21:1.
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Junhao Liu, Jo Wick, Yu Jiang, Matthew Mayo & Byron Gajewski. (2020) Bayesian accrual modeling and prediction in multicenter clinical trials with varying center activation times. Pharmaceutical Statistics 19:5, pages 692-709.
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Vladimir V. Anisimov. 2020. Quantitative Methods in Pharmaceutical Research and Development. Quantitative Methods in Pharmaceutical Research and Development 361 408 .
Anh Ninh, Michael LeFew & Vladimir Anisimov. (2019) Clinical Trial Simulation: Modeling and Practical Considerations. Clinical Trial Simulation: Modeling and Practical Considerations.
Efstathia Gkioni, Roser Rius, Susanna Dodd & Carrol Gamble. (2019) A systematic review describes models for recruitment prediction at the design stage of a clinical trial. Journal of Clinical Epidemiology 115, pages 141-149.
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Linda E. Carlson, Utkarsh B. Subnis, Katherine‐Anne L. Piedalue, James Vallerand, Michael Speca, Sasha Lupichuk, Patricia Tang, Peter Faris & Ruth Q. Wolever. (2019) The ONE‐MIND Study: Rationale and protocol for assessing the effects of ONlinE MINDfulness‐based cancer recovery for the prevention of fatigue and other common side effects during chemotherapy. European Journal of Cancer Care 28:4.
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Fang‐Shu Ou, Martin Heller & Qian Shi. (2019) Milestone prediction for time‐to‐event endpoint monitoring in clinical trials. Pharmaceutical Statistics 18:4, pages 433-446.
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Lisa V Hampson, Paula R Williamson, Martin J Wilby & Thomas Jaki. (2017) A framework for prospectively defining progression rules for internal pilot studies monitoring recruitment. Statistical Methods in Medical Research 27:12, pages 3612-3627.
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Gilyana Borlikova, Louis Smith, Michael Phillips & Michael O’Neill. 2018. Handbook of Grammatical Evolution. Handbook of Grammatical Evolution 461 486 .
Nathan Minois, Guillaume Mijoule, Stéphanie Savy, Valérie Lauwers-Cances, Sandrine Andrieu & Nicolas Savy. 2018. Statistics and Simulation. Statistics and Simulation 285 299 .
Nathan Minois, Valérie Lauwers‐Cances, Stéphanie Savy, Michel Attal, Sandrine Andrieu, Vladimir Anisimov & Nicolas Savy. (2017) Using Poisson–gamma model to evaluate the duration of recruitment process when historical trials are available. Statistics in Medicine 36:23, pages 3605-3620.
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Nathan Minois, Stéphanie Savy, Valérie Lauwers-Cances, Sandrine Andrieu & Nicolas Savy. (2017) How to deal with the Poisson-gamma model to forecast patients' recruitment in clinical trials when there are pauses in recruitment dynamic?. Contemporary Clinical Trials Communications 5, pages 144-152.
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Vladimir V. Anisimov. (2016) Discussion on the paper “Real-Time Prediction of Clinical Trial Enrollment and Event Counts: A Review”, by DF Heitjan, Z Ge, and GS Ying. Contemporary Clinical Trials 46, pages 7-10.
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Daniel F. Heitjan, Zhiyun Ge & Gui-shuang Ying. (2015) Real-time prediction of clinical trial enrollment and event counts: A review. Contemporary Clinical Trials 45, pages 26-33.
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Guillaume Mijoule, Nathan Minois, Vladimir V. Anisimov & Nicolas Savy. 2014. Topics in Statistical Simulation. Topics in Statistical Simulation 373 381 .
Weili He & Xiting Cao. 2014. Practical Considerations for Adaptive Trial Design and Implementation. Practical Considerations for Adaptive Trial Design and Implementation 299 318 .
Andisheh BakhshiStephen Senn & Alan Phillips. (2013) Some issues in predicting patient recruitment in multi‐centre clinical trials. Statistics in Medicine 32:30, pages 5458-5468.
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Vladimir V. Anisimov. (2012) Discussion on the paper ‘Prediction of accrual closure date in multi‐center clinical trials with discrete‐time Poisson process models’, by Gong Tang, Yuan Kong, Chung‐Chou Ho Chang, Lan Kong, and Joseph P. Costantino. Pharmaceutical Statistics 11:5, pages 357-358.
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Vladimir V. Anisimov. (2011) Predictive event modelling in multicenter clinical trials with waiting time to response. Pharmaceutical Statistics 10:6, pages 517-522.
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