Type I error rate control in adaptive designs for confirmatory clinical trials with treatment selection at interim

Martin Posch, Willi Maurer, Frank Bretz

Type: Article

Publication Date: 2010-04-07

Citations: 45

DOI: https://doi.org/10.1002/pst.413

View Publication

Locations

Pharmaceutical Statistics - View
PubMed - View

Similar Works

Action	Title	Year	Authors
+	Adaptive designs for confirmatory clinical trials	2009	Frank Bretz Franz Koenig Werner Brannath Ekkehard Glimm Martin Posch
+	Faculty Opinions recommendation of Adaptive designs for confirmatory clinical trials.	2010	Steven A. Julious
+ PDF Chat	Adaptive Trial Designs	2011	Tze Leung Lai Philip W. Lavori Mei‐Chiung Shih
+	Point estimation in adaptive confirmatory clinical trials with time-to-event data and treatment or subgroup selection	2017	Josephine Naz Khan
+ PDF Chat	A systematic approach to adaptive sequential design for clinical trials: using simulations to select a design with desired operating characteristics	2024	Ping Gao Weidong Zhang
+ PDF Chat	Adaptive Clinical Trial Design	2014	Shein‐Chung Chow
+	Characteristics and Principles of Adaptive Trial Designs	2023	Jay Park J. Kyle Wathen Edward J. Mills
+	Methods to improve the efficiency of confirmatory clinical trials	2013	Ruud Boessen
+	Multiple testing in adaptive designs–a review	2004	Martin Hellmich Gerhard Hommel
+	An adaptive confirmatory trial with interim treatment selection: Practical experiences and unbalanced randomization	2011	Stéphane Héritier Serigne Lo Caroline C. Morgan
+	Adaptive Trials and Interim Analysis	2018	Priscila Caldeira Andrade Nazem Atassi Laura Castillo-Saavedra André R. Brunoni Felipe Fregni
+ PDF Chat	An evaluation of inferential procedures for adaptive clinical trial designs with pre‐specified rules for modifying the sample size	2014	Gregory P. Levin Sarah C. Emerson Scott S. Emerson
+	Interim Analysis in Adaptive Randomized Clinical Trials	2019	Xin Li
+	Adaptive Clinical Trial Designs	2013
+ PDF Chat	Confidence intervals for adaptive trial designs II: Case study and practical guidance	2024	David S. Robertson Thomas J Burnett Babak Choodari‐Oskooei Munyaradzi Dimairo Michael J. Grayling Philip Pallmann Thomas Jaki
+ PDF Chat	Adaptive design of confirmatory trials: Advances and challenges	2015	Tze Leung Lai Philip W. Lavori Ka Wai Tsang
+ PDF Chat	Treatment selection in multi-arm, multi-stage clinical trials	2013	Thomas Jaki Dominic Magirr Nigel Stallard
+	Interim Analysis and Adaptive Design in Clinical Trials	2019
+	Two‐stage adaptive strategy for superiority and non‐inferiority hypotheses in active controlled clinical trials	2004	Weichung Joe Shih Hui Quan Gang Li
+ PDF Chat	Maximum type 1 error rate inflation in multiarmed clinical trials with adaptive interim sample size modifications	2014	Alexandra Gráf Péter Bauer Ekkehard Glimm Franz Koenig

Works That Cite This (41)

Action	Title	Year	Authors
+	START: single‐to‐double arm transition design for phase II clinical trials	2020	Haolun Shi Teng Zhang Guosheng Yin
+	Flexible alpha allocation strategies for confirmatory adaptive enrichment clinical trials with a prespecified subgroup	2018	Toshifumi Sugitani Martin Posch Frank Bretz Franz Koenig
+ PDF Chat	Adaptive Design - Recent Advancement in Clinical Trials	2016	Mark Chang
+	Controlling the type I error rate in two‐stage sequential adaptive designs when testing for average bioequivalence	2018	Willi Maurer Byron Jones Chen Ying
+	Adaptive designs for clinical trials	2021	PraveenK Nirmalan
+	Multiplicity Adjustment in Seamless Phase II/III Adaptive Trials Using Biomarkers for Dose Selection	2015	Pei Li Yanli Zhao Xiao Sun Ivan S. F. Chan
+ PDF Chat	Maximum type 1 error rate inflation in multiarmed clinical trials with adaptive interim sample size modifications	2014	Alexandra Gráf Péter Bauer Ekkehard Glimm Franz Koenig
+	Adaptive design clinical trials: current status by disease and trial phase in various perspectives	2023	H. Lee Sejung Hwang In‐Jin Jang Jae‐Yong Chung Jaeseong Oh
+ PDF Chat	Adaptive trial designs for spinal cord injury clinical trials directed to the central nervous system	2020	M.J. Mulcahey Linda Jones Frank W. Rockhold R. Rupp John L. K. Kramer Steven Kirshblum Andrew R. Blight Daniel P. Lammertse James D. Guest John D. Steeves
+	Regulatory Perspectives on Multiplicity in Adaptive Design Clinical Trials throughout a Drug Development Program	2011	Sue‐Jane Wang Hung Hung Robert T. O’Neill

Works Cited by This (16)

Action	Title	Year	Authors
+	Combining different phases in the development of medical treatments within a single trial	1999	Péter Bauer Meinhard Kieser
+	Adaptive Dunnett tests for treatment selection	2007	Franz Koenig Werner Brannath Frank Bretz Martin Posch
+	Adaptive designs for confirmatory clinical trials	2009	Frank Bretz Franz Koenig Werner Brannath Ekkehard Glimm Martin Posch
+	Confirmatory Seamless Phase II/III Clinical Trials with Hypotheses Selection at Interim: General Concepts	2006	Frank Bretz Heinz Schmidli Franz König Amy Racine Willi Maurer
+ PDF Chat	Testing and estimation in flexible group sequential designs with adaptive treatment selection	2005	Martin Posch Franz Koenig Michael Branson Werner Brannath Cornelia Dunger‐Baldauf Péter Bauer
+	A Unified Theory of Two-Stage Adaptive Designs	2002	Qing Liu Michael A. Proschan Gordon Pledger
+	Adaptive Modifications of Hypotheses After an Interim Analysis	2001	Gerhard Hommel
+	Two-stage selection and testing designs for comparative clinical trials	1988	Peter F. Thall Richard Simon Susan S. Ellenberg
+	Sequentially testing for a gene–drug interaction in a genomewide analysis	2007	Patrick J. Kelly Yinghui Zhou John Whitehead Nigel Stallard Clive Bowman
+	A Two-Stage Design for Choosing among Several Experimental Treatments and a Control in Clinical Trials	1989	Peter F. Thall Richard Simon Susan S. Ellenberg