Marietta Kirchner

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All published works
Action Title Year Authors
+ drugdevelopR: Planning of phase II/III drug development programs with optimal sample size allocation and Go/No-go decision rules in R 2025 Johannes Cepicka
Lukas D. Sauer
Marietta Kirchner
Meinhard Kieser
Stella Erdmann
+ PDF Chat Optimal sample size allocation for two‐arm superiority and non‐inferiority trials with binary endpoints 2024 Marietta Kirchner
Stefanie SchĂŒpke
Meinhard Kieser
+ Drugdevelopr: Planning of Phase Ii/Iii Drug Development Programs with Optimal Sample Size Allocation and Go/No-Go Decision Rules in R 2024 Johannes Cepicka
Lukas D. Sauer
Marietta Kirchner
Meinhard Kieser
Stella Erdmann
+ Estimation of treatment effects in early-phase randomized clinical trials involving external control data 2023 Heiko Götte
Marietta Kirchner
Johannes Krisam
Arthur Allignol
Armin SchĂŒler
Meinhard Kieser
+ An adaptive design for early clinical development including interim decision for single‐arm trial with external controls or randomized trial 2022 Heiko Götte
Marietta Kirchner
Johannes Krisam
Arthur Allignol
François-Xavier Lamy
Armin SchĂŒler
Meinhard Kieser
+ Estimands—a basic element for clinical trials. Part 29 of a series on evaluation of scientific publications 2021 Moritz Pohl
Lukas Baumann
Rouven Behnisch
Marietta Kirchner
Johannes Krisam
Anja Sander
+ PDF Chat Optimal designs for phase II/III drug development programs including methods for discounting of phase II results 2020 Stella Erdmann
Marietta Kirchner
Heiko Götte
Meinhard Kieser
+ Optimal decision‐making in oncology development programs based on probability of success for phase <scp>III</scp> utilizing phase <scp>II</scp>/<scp>III</scp> data on response and overall survival 2020 Heiko Götte
Junyuan Xiong
Marietta Kirchner
Hakan DemirtaƟ
Meinhard Kieser
+ PDF Chat Optimal Designs for Multi-Arm Phase II/III Drug Development Programs 2019 Stella Preussler
Marietta Kirchner
Heiko Götte
Meinhard Kieser
+ PDF Chat Adjustment for exploratory cut‐off selection in randomized clinical trials with survival endpoint 2019 Heiko Götte
Marietta Kirchner
Meinhard Kieser
+ Optimal sample size allocation and go/no-go decision rules for phase II/III programs where several phase III trials are performed 2018 Stella Preussler
Meinhard Kieser
Marietta Kirchner
+ Optimal planning of phase II/III programs for clinical trials with multiple endpoints 2018 Meinhard Kieser
Marietta Kirchner
Eva Dölger
Heiko Götte
+ Simulation-based adjustment after exploratory biomarker subgroup selection in phase II 2017 Heiko Götte
Marietta Kirchner
Martin Oliver Sailer
Meinhard Kieser
+ Probability of success for phase III after exploratory biomarker analysis in phase II 2017 Heiko Götte
Marietta Kirchner
Martin Oliver Sailer
+ Sample size planning for phase II trials based on success probabilities for phase III 2015 Heiko Götte
Armin SchĂŒler
Marietta Kirchner
Meinhard Kieser
+ Utility‐based optimization of phase II/III programs 2015 Marietta Kirchner
Meinhard Kieser
Heiko Götte
Armin SchĂŒler
+ A multiple filter test for the detection of rate changes in renewal processes with varying variance 2014 Michael Messer
Marietta Kirchner
Julia Schiemann
Jochen Roeper
Ralph Neininger
Gaby Schneider
+ A multiple filter test for change point detection in renewal processes with varying variance 2013 Michael Messer
Marietta Kirchner
Julia Schiemann
Jochen Roeper
Ralph Neininger
Gaby Schneider
Common Coauthors
Commonly Cited References
Action Title Year Authors # of times referenced
+ Assurance in clinical trial design 2005 Anthony O’Hagan
John Stevens
Michael J. Campbell
9
+ Sample size planning for phase II trials based on success probabilities for phase III 2015 Heiko Götte
Armin SchĂŒler
Marietta Kirchner
Meinhard Kieser
8
+ Discounting phase 2 results when planning phase 3 clinical trials 2012 Simon Kirby
James R. Burke
Christy Chuang‐Stein
Chanthy Sin
6
+ Adapting by calibration the sample size of a phase III trial on the basis of phase II data 2010 Daniele De Martini
6
+ Sample size and the probability of a successful trial 2006 Christy Chuang‐Stein
6
+ The asymptotic properties of nonparametric tests for comparing survival distributions 1981 David Schoenfeld
6
+ PDF Chat Adapting the sample size planning of a phase III trial based on phase II data 2006 Sue‐Jane Wang
Hung Hung
Robert T. O’Neill
5
+ Utility‐based optimization of phase II/III programs 2015 Marietta Kirchner
Meinhard Kieser
Heiko Götte
Armin SchĂŒler
5
+ PDF Chat Assumptions of Expected Benefits in Randomized Phase III Trials Evaluating Systemic Treatments for Cancer 2012 Hui Gan
BenoĂźt You
Gregory R. Pond
E. X. Chen
5
+ PDF Chat Bayesian cost‐effectiveness analysis from clinical trial data 2001 Anthony O’Hagan
John Stevens
Jacques Montmartin
4
+ Assessing the success probability of a Phase III clinical trial based on Phase II data 2010 Zheng Su
4
+ A predictive approach to selecting the size of a clinical trial, based on subjective clinical opinion 1986 David J. Spiegelhalter
Laurence S. Freedman
4
+ Bayesian Approaches to Randomized Trials 1994 David J. Spiegelhalter
Laurence S. Freedman
Mahesh Parmar
3
+ Statistical consideration of the strategy for demonstrating clinical evidence of effectiveness—one larger vs two smaller pivotal studies by Z. Shun, E. Chi, S. Durrleman and L. Fisher, <i>Statistics in Medicine</i> 2005; <b>24</b>:1619–1637 2005 Gary G. Koch
3
+ PDF Chat Clinical Trial Evidence Supporting FDA Approval of Novel Therapeutic Agents, 2005-2012 2014 Nicholas S. Downing
Jenerius A. Aminawung
Nilay D. Shah
Harlan M. Krumholz
Joseph S. Ross
3
+ RECONSIDERING SOME ASPECTS OF THE TWO-TRIALS PARADIGM 2002 Jeff Maca
P. Gallo
Michael Branson
Willi Maurer
3
+ A Revisit of Sample Size Decisions in Confirmatory Trials 2010 Christy Chuang‐Stein
Ruoyong Yang
3
+ A Bayesian approach for incorporating economic factors in sample size design for clinical trials of individual drugs and portfolios of drugs 2007 Nitin R. Patel
Suresh Ankolekar
3
+ Stopping rules and estimation problems in clinical trials 1988 Michael D. Hughes
Stuart J. Pocock
3
+ Statistical consideration of the strategy for demonstrating clinical evidence of effectiveness—one larger vs two smaller pivotal studies 2004 Zhenming Shun
Eric Chi
Sylvain Durrleman
Lloyd D. Fisher
3
+ Optimal Sample Sizes and Go/No-Go Decisions for Phase II/III Development Programs Based on Probability of Success 2011 Kaihong Jiang
3
+ PDF Chat Bayesian Optimal Design for Phase II Screening Trials 2007 Meichun Ding
Gary L. Rosner
Peter MĂŒller
3
+ PDF Chat A mathematical model for maximizing the value of phase 3 drug development portfolios incorporating budget constraints and risk 2013 Nitin R. Patel
Suresh Ankolekar
Zoran Antonijevic
Natasa Rajicic
3
+ PDF Chat Optimal Designs for Multi-Arm Phase II/III Drug Development Programs 2019 Stella Preussler
Marietta Kirchner
Heiko Götte
Meinhard Kieser
3
+ Conditional Bias of Point Estimates Following a Group Sequential Test 2004 Xiaoyin Fan
David L. DeMets
K. K. Gordon Lan
3
+ The shrinking or disappearing observed treatment effect 2014 Christy Chuang‐Stein
Simon Kirby
3
+ Optimal sample size allocation and go/no-go decision rules for phase II/III programs where several phase III trials are performed 2018 Stella Preussler
Meinhard Kieser
Marietta Kirchner
3
+ Key multiplicity issues in clinical drug development 2012 Alex Dmitrienko
Ralph B. D’Agostino
Mohammad F. Huque
3
+ One Large, Well-Designed, Multicenter Study as an Alternative to the Usual Fda Paradigm 1999 Lloyd D. Fisher
3
+ PDF Chat Multiple Co-primary Endpoints: Medical and Statistical Solutions: A Report from the Multiple Endpoints Expert Team of the Pharmaceutical Research and Manufacturers of America 2007 Walter Offen
Christy Chuang‐Stein
Alex Dmitrienko
Gary S. Littman
Jeff Maca
Laura A. Meyerson
Robb J. Muirhead
Paul Stryszak
Alex Baddy
Kun Chen
3
+ Multi-State Models for Panel Data: The<b>msm</b>Package for<i>R</i> 2011 Christopher Jackson
2
+ PDF Chat Matching Methods for Causal Inference: A Review and a Look Forward 2010 Elizabeth A. Stuart
2
+ PDF Chat The relationship between the power prior and hierarchical models 2006 Ming‐Hui Chen
Joseph G. Ibrahim
2
+ Computation of Multivariate Normal and t Probabilities 2009 Alan Genz
Frank Bretz
2
+ An adaptive seamless phase II/III design for oncology trials with subpopulation selection using correlated survival endpoints† 2010 Martin Jenkins
Andrew Stone
Christopher Jennison
2
+ The relationship between six-month progression-free survival and 12-month overall survival end points for phase II trials in patients with glioblastoma multiforme 2006 Karla V. Ballman
Jan C. Buckner
Paul D. Brown
Caterina Giannini
Patrick J. Flynn
Betsy LaPlant
Kurt A. Jaeckle
2
+ PDF Chat A Quantitative Process for Enhancing End of Phase 2 Decisions 2013 Tony Sabin
James Matcham
Sarah Bray
Andrew Copas
Mahesh Parmar
2
+ The role of the minimum clinically important difference and its impact on designing a trial 2010 Christy Chuang‐Stein
Simon Kirby
Ian Hirsch
Gary Atkinson
2
+ Randomized Phase II Trials: Inevitable or Inadvisable? 2010 Hui Gan
Axel Grothey
Gregory R. Pond
Malcolm J. Moore
Lillian L. Siu
Daniel J. Sargent
2
+ PDF Chat Use of historical control data for assessing treatment effects in clinical trials 2013 Kert Viele
Scott Berry
Beat Neuenschwander
Billy Amzal
Fang Chen
Nathan Enas
Brian P. Hobbs
Joseph G. Ibrahim
Nelson Kinnersley
Stacy Lindborg
2
+ Sequentially updating the likelihood of success of a Phase 3 pivotal time-to-event trial based on interim analyses or external information 2014 Kaspar Rufibach
Paul Jordan
Markus Abt
2
+ Sample size calculation for the log-rank tests for multi-arm trials with a control 2008 Sin‐Ho Jung
Choong-Rak Kim
Shein‐Chung Chow
2
+ PDF Chat A simulation-based approach to Bayesian sample size determination for performance under a given model and for separating models 2002 Alan E. Gelfand
Fei Wang
2
+ Bootstrap corrections of treatment effect estimates following selection 2013 G. Rosenkranz
2
+ PDF Chat Approximate Bayesian Computation 2013 Mikael SunnÄker
Alberto Giovanni Busetto
Elina Numminen
Jukka Corander
Matthieu Foll
Christophe Dessimoz
2
+ Decision Making from Phase II to Phase III and the Probability of Success: Reassured by “Assurance”? 2013 Kevin J. Carroll
2
+ Accounting for Variability in Sample Size Estimation with Applications to Nonadherence and Estimation of Variance and Effect Size 2006 Michael P. Fay
M. Elizabeth Halloran
Dean Follmann
2
+ Novel designs for multi‐arm clinical trials with survival outcomes with an application in ovarian cancer 2003 Patrick Royston
Mahesh Parmar
Wendi Qian
2
+ A Bayesian Approach to Subgroup Identification 2014 James O. Berger
Xiaojing Wang
Lei Shen
2
+ Categorical Data Analysis 2002 Alan Agresti
2