Publikationen

@ARTICLE{hagemann2024tsmmujae077,
  author = {Hagemann, N.~ and Marra, G.~ and Bretz, F.~ and M{\"o}llenhoff, K.~},
  title = {Testing for Similarity of Multivariate Mixed Outcomes Using Generalized Joint Regression Models with Application to Efficacy-Toxicity Responses.},
  journal = {Biometrics},
  year = {2024},
  volume = {80},
  number = {3},
  pages = {ujae077},
  issn = {1541-0420 0006-341X},
  doi = {10.1093/biomtc/ujae077},
  keywords = {Humans;Multivariate Analysis;Treatment Outcome;Data Interpretation;Statistical;Clinical Trials as Topic;*Models;Statistical;Regression Analysis;bootstrap;Biometry/methods;*Computer Simulation;copula;dose-response models;model-based equivalence tests}
}

@ARTICLE{vanlancker2024rthc415417,
  author = {Van Lancker, K.~ and Bretz, F.~ and Dukes, O.~},
  title = {Response to Harrell’s Commentary.},
  journal = {Clinical Trials},
  year = {2024},
  volume = {21},
  number = {4},
  pages = {415--417},
  issn = {1740-7753 1740-7745},
  doi = {10.1177/17407745241251851}
}

@ARTICLE{vanlancker2024carc399411,
  author = {Van Lancker, K.~ and Bretz, F.~ and Dukes, O.~},
  title = {Covariate Adjustment in Randomized Controlled Trials: General Concepts and Practical Considerations.},
  journal = {Clinical Trials},
  year = {2024},
  volume = {21},
  number = {4},
  pages = {399--411},
  issn = {1740-7753 1740-7745},
  doi = {10.1177/17407745241251568},
  keywords = {Baseline covariates;covariate adjustment;efficiency gain;estimands}
}

@ARTICLE{izem2024dcts495504,
  author = {Izem, R.~ and Zuber, E.~ and Daizadeh, N.~ and Bretz, F.~ and Sverdlov, O.~ and Edrich, P.~ and Branson, J.~ and Degtyarev, E.~ and Sfikas, N.~ and Hemmings, R.~},
  title = {Decentralized Clinical Trials: Scientific Considerations through the Lens of the Estimand Framework.},
  journal = {Therapeutic Innovation \& Regulatory Science},
  year = {2024},
  volume = {58},
  pages = {495--504},
  issn = {2168-4804 2168-4790},
  doi = {10.1007/s43441-024-00615-8},
  keywords = {Decentralization component;Estimand attributes;Patient-centric;Virtual clinical trials}
}

@ARTICLE{maurer2023otpm27812793,
  author = {Maurer, W.~ and Bretz, F.~ and Xun, X.~},
  title = {Optimal Test Procedures for Multiple Hypotheses Controlling the Familywise Expected Loss.},
  journal = {Biometrics},
  year = {2023},
  volume = {79},
  number = {4},
  pages = {2781--2793},
  issn = {1541-0420 0006-341X},
  doi = {10.1111/biom.13907},
  keywords = {subgroup analysis;multiple testing;familywise error rate;gain function;loss function}
}

@ARTICLE{maurer2023rtdo28112814,
  author = {Maurer, W.~ and Bretz, F.~ and Xun, X.~},
  title = {Rejoinder to Discussions on “Optimal Test Procedures for Multiple Hypotheses Controlling the Familywise Expected Loss”.},
  journal = {Biometrics},
  year = {2023},
  volume = {79},
  number = {4},
  pages = {2811--2814},
  issn = {1541-0420 0006-341X},
  doi = {10.1111/biom.13905}
}

@ARTICLE{ionan2023cspi554559,
  author = {Ionan, A.~ and Paterniti, M.~ and Mehrotra, D.~ and Scott, J.~ and Ratitch, B.~ and Collins, S.~ and Gomatam, S.~ and Nie, L.~ and Rufibach, K.~ and Bretz, F.~},
  title = {Clinical and Statistical Perspectives on the ICH E9(R1) Estimand Framework Implementation.},
  journal = {Statistics in Biopharmaceutical Research},
  year = {2023},
  volume = {15},
  number = {3},
  pages = {554--559},
  issn = {1946-6315},
  doi = {10.1080/19466315.2022.2081601}
}

@ARTICLE{dungerbaldauf2023grea11321138,
  author = {Dunger-Baldauf, C.~ and Hemmings, R.~ and Bretz, F.~ and Jones, B.~ and Schiel, A.~ and Holmes, C.~},
  title = {Generating the Right Evidence at the Right Time: Principles of a New Class of Flexible Augmented Clinical Trial Designs.},
  journal = {Clinical Pharmacology and Therapeutics},
  year = {2023},
  volume = {113},
  number = {5},
  pages = {1132--1138},
  issn = {1532-6535 0009-9236},
  doi = {10.1002/cpt.2869}
}

@ARTICLE{vanlancker2023etec94111,
  author = {Van Lancker, K.~ and Tarima, S.~ and Bartlett, J.~ and Bauer, M.~ and Bharani-Dharan, B.~ and Bretz, F.~ and Flournoy, N.~ and Michiels, H.~ and Parra, C.~ and Rosenberger, J.~ and Cro, S.~},
  title = {Estimands and their Estimators for Clinical Trials Impacted by the COVID-19 Pandemic: A Report from the NISS Ingram Olkin Forum Series on Unplanned Clinical Trial Disruptions.},
  journal = {Statistics in Biopharmaceutical Research},
  year = {2023},
  volume = {15},
  number = {1},
  pages = {94--111},
  issn = {1946-6315},
  doi = {10.1080/19466315.2022.2094459}
}

@ARTICLE{vanlancker2023rete119124,
  author = {Van Lancker, K.~ and Tarima, S.~ and Bartlett, J.~ and Bauer, M.~ and Bharani-Dharan, B.~ and Bretz, F.~ and Flournoy, N.~ and Michiels, H.~ and Parra, C.O.~ and Rosenberger, J.L.~ and Cro, S.~},
  title = {Rejoinder: Estimands and their Estimators for Clinical Trials Impacted by the COVID-19 Pandemic: A Report from the NISS Ingram Olkin Forum Series on Unplanned Clinical Trial Disruptions.},
  journal = {Statistics in Biopharmaceutical Research},
  year = {2023},
  volume = {15},
  number = {1},
  pages = {119--124},
  doi = {10.1080/19466315.2022.2162958},
  url = {https://www.scopus.com/inward/record.uri?eid=2-s2.0-85147952730\&doi=10.1080%2f19466315.2022.2162958\&partnerID=40\&md5=ec8c39a925329ba10181ad4eb1ef2ba4}
}

@ARTICLE{collignon2022ecid11831190,
  author = {Collignon, O.~ and Schiel, A.~ and Burman, C.-F.~ and Rufibach, K.~ and Posch, M.~ and Bretz, F.~},
  title = {Estimands and Complex Innovative Designs.},
  journal = {Clinical Pharmacology and Therapeutics},
  year = {2022},
  volume = {112},
  number = {6},
  pages = {1183--1190},
  issn = {1532-6535 0009-9236},
  doi = {10.1002/cpt.2575},
  keywords = {adaptive design;master protocol;platform trial;regulatory policy;ICH E9 addendum}
}

@ARTICLE{haliduola2022mdiu107172,
  author = {Haliduola, H.N.~ and Bretz, F.~ and Mansmann, U.~},
  title = {Missing Data Imputation Using Utility-Based Regression and Sampling Approaches.},
  journal = {Computer Methods and Programs in Biomedicine},
  year = {2022},
  volume = {226},
  pages = {107172},
  issn = {1872-7565 0169-2607},
  doi = {10.1016/j.cmpb.2022.107172},
  keywords = {Cross-Sectional Studies;Data Interpretation;Statistical;Clinical Trials as Topic;*Research Design;Bias;Machine learning;Data Collection/methods;Missing data;SMOTER;Utility-based regression}
}

@ARTICLE{baillie2022stct13611362,
  author = {Baillie, M.~ and Bretz, F.~},
  title = {Statistical Thinking in Clinical Trials.},
  journal = {Biometrical Journal},
  year = {2022},
  volume = {64},
  number = {7},
  pages = {1361--1362},
  note = {[Book Review]},
  issn = {0323-3847},
  doi = {10.1002/bimj.202200192}
}

@ARTICLE{maurer2022ruag757763,
  author = {Maurer, W.~ and Bretz, F.~ and Posch, M.~},
  title = {Rationale for the Update Algorithm of the Graphical Approach to Sequentially Rejective Multiple Test Procedures.},
  journal = {Pharmaceutical Statistics},
  year = {2022},
  volume = {21},
  number = {4},
  pages = {757--763},
  issn = {1539-1612 1539-1604},
  doi = {10.1002/pst.2227},
  keywords = {Algorithms;Humans;Data Interpretation;Statistical;*Models;Statistical;*multiple endpoints;*multiple testing;*Biostatistics;*clinical trials;*Markov chain}
}

@ARTICLE{haliduola2022mdic863882,
  author = {Haliduola, H.N.~ and Bretz, F.~ and Mansmann, U.~},
  title = {Missing Data Imputation in Clinical Trials Using Recurrent Neural Network Facilitated by Clustering and Oversampling.},
  journal = {Biometrical Journal},
  year = {2022},
  volume = {64},
  number = {5},
  pages = {863--882},
  issn = {1521-4036 0323-3847},
  doi = {10.1002/bimj.202000393},
  keywords = {Humans;Data Interpretation;Statistical;Bias;Likelihood Functions;*clinical trial;Cluster Analysis;*Neural Networks;Computer;* k $k$ -mean clustering;*missing data;*oversampling;*recurrent neural network}
}

@ARTICLE{hamasaki2022wiem381388,
  author = {Hamasaki, T.~ and Bretz, F.~},
  title = {What Is an Estimand?—The Most Important Clinical Question in Oncology Trials.},
  journal = {Gan to kagaku ryōhō [Japanese Journal of Cancer and Chemotherapy]},
  year = {2022},
  volume = {49},
  number = {4},
  pages = {381--388},
  url = {https://pubmed.ncbi.nlm.nih.gov/35444118/}
}

@ARTICLE{hamasaki2022meoc371380,
  author = {Hamasaki, T.~ and Bretz, F.~},
  title = {Multiple Endpoints in Oncology Clinical Trials [in Japanese]},
  journal = {Gan to kagaku ryōhō [Japanese Journal of Cancer and Chemotherapy]},
  year = {2022},
  volume = {49},
  number = {4},
  pages = {371--380},
  url = {https://pubmed.ncbi.nlm.nih.gov/35444117/}
}

@ARTICLE{xi2022dclc243245,
  author = {Xi, D.~ and Bretz, F.~},
  title = {Discussion on ‘Correct and Logical Causal Inference for Binary and Time-to-Event Outcomes in Randomized Controlled Trials’.},
  journal = {Biometrical Journal},
  year = {2022},
  volume = {64},
  number = {2},
  pages = {243--245},
  issn = {1521-4036 0323-3847},
  doi = {10.1002/bimj.202100060}
}

@ARTICLE{cooner2022sicc12,
  author = {Cooner, F.~ and Hamasaki, T.~ and Bretz, F.~ and Pennello, G.~ and Posch, M.~},
  title = {Statistical Issues and Challenges in Clinical Trials for COVID-19 Treatments, Vaccines, Medical Devices and Diagnostics.},
  journal = {Statistics in Biopharmaceutical Research},
  year = {2022},
  volume = {14},
  number = {1},
  pages = {1--2},
  doi = {10.1080/19466315.2021.2003122},
  url = {https://www.scopus.com/inward/record.uri?eid=2-s2.0-85121550280\&doi=10.1080%2f19466315.2021.2003122\&partnerID=40\&md5=9cc4d0d0a4e6e359df14d98e0dc90f92}
}

@ARTICLE{mccaw2021ccis62356242,
  author = {McCaw, Z.R.~ and Tian, L.~ and Wei, J.~ and Claggett, B.L.~ and Bretz, F.~ and Fitzmaurice, G.~ and Wei, L.-J.~},
  title = {Choosing Clinically Interpretable Summary Measures and Robust Analytic Procedures for Quantifying the Treatment Difference in Comparative Clinical Studies.},
  journal = {Statistics in Medicine},
  year = {2021},
  volume = {40},
  number = {28},
  pages = {6235--6242},
  issn = {1097-0258 0277-6715},
  doi = {10.1002/sim.8971}
}

@ARTICLE{bowden2021civm56055627,
  author = {Bowden, J.~ and Bornkamp, B.~ and Glimm, E.~ and Bretz, F.~},
  title = {Connecting Instrumental Variable Methods for Causal Inference to the Estimand Framework.},
  journal = {Statistics in Medicine},
  year = {2021},
  volume = {40},
  number = {25},
  pages = {5605--5627},
  issn = {1097-0258 0277-6715},
  doi = {10.1002/sim.9143},
  keywords = {Humans;Data Interpretation;Statistical;*Research Design;Causality;*causal inference;*Drug Development;*E9 addendum;*Estimand Framework;*Homogeneity;*IV methods;*Monotonicity;Drug Industry}
}

@ARTICLE{hamasaki2021sbrb129130,
  author = {Hamasaki, T.~ and Bretz, F.~},
  title = {Statistics in Biopharmaceutical Research Best Papers Award.},
  journal = {Statistics in Biopharmaceutical Research},
  year = {2021},
  volume = {13},
  number = {2},
  pages = {129--130},
  doi = {10.1080/19466315.2021.1912479},
  url = {https://www.scopus.com/inward/record.uri?eid=2-s2.0-85105119643\&doi=10.1080%2f19466315.2021.1912479\&partnerID=40\&md5=1382ec84616067f75ed3cbcd6643f5f7}
}

@ARTICLE{hamasaki2021erht15,
  author = {Hamasaki, T.~ and Bretz, F.~ and LaVange, L.M.~ and M{\"u}ller, P.~ and Pennello, G.~ and Pinheiro, J.C.~},
  title = {Editorial: Roles of Hypothesis Testing, p-Values and Decision Making in Biopharmaceutical Research.},
  journal = {Statistics in Biopharmaceutical Research},
  year = {2021},
  volume = {13},
  number = {1},
  pages = {1--5},
  doi = {10.1080/19466315.2021.1874803},
  url = {https://www.scopus.com/inward/record.uri?eid=2-s2.0-85101244167\&doi=10.1080%2f19466315.2021.1874803\&partnerID=40\&md5=4d8c2fcb73521db9a503c29d3db667ed}
}

@ARTICLE{hamasaki2020sccm397398,
  author = {Hamasaki, T.~ and Bretz, F.~ and Cooner, F.~ and LaVange, L.M.~ and Posch, M.~},
  title = {Statistical Challenges in the Conduct and Management of Ongoing Clinical Trials during the COVID-19 Pandemic.},
  journal = {Statistics in Biopharmaceutical Research},
  year = {2020},
  volume = {12},
  number = {4},
  pages = {397--398},
  issn = {null},
  doi = {10.1080/19466315.2020.1828692},
  url = {https://doi.org/10.1080/19466315.2020.1828692}
}

@ARTICLE{akacha2020caic419426,
  author = {Akacha, M.~ and Branson, J.~ and Bretz, F.~ and Dharan, B.~ and Gallo, P.~ and Gathmann, I.~ and Hemmings, R.~ and Jones, J.~ and Xi, D.~ and Zuber, E.~},
  title = {Challenges in Assessing the Impact of the COVID-19 Pandemic on the Integrity and Interpretability of Clinical Trials.},
  journal = {Statistics in Biopharmaceutical Research},
  year = {2020},
  volume = {12},
  number = {4},
  pages = {419--426},
  doi = {10.1080/19466315.2020.1788984},
  url = {https://www.scopus.com/inward/record.uri?eid=2-s2.0-85089484860\&doi=10.1080%2f19466315.2020.1788984\&partnerID=40\&md5=82181fdaa92121a8b8e6c393430e64af}
}

@ARTICLE{robertson2020gacg31353155,
  author = {Robertson, D.S.~ and Wason, J.M.S.~ and Bretz, F.~},
  title = {Graphical Approaches for the Control of Generalized Error Rates.},
  journal = {Statistics in Medicine},
  year = {2020},
  volume = {39},
  number = {23},
  pages = {3135--3155},
  doi = {10.1002/sim.8595},
  url = {https://www.scopus.com/inward/record.uri?eid=2-s2.0-85086506602\&doi=10.1002%2fsim.8595\&partnerID=40\&md5=ba983d628b4df40053182a9b4d429d4e}
}

@ARTICLE{bretz2020cpw567569,
  author = {Bretz, F.~ and Koenig, F.~},
  title = {Commentary on Parker and Weir.},
  journal = {Clinical Trials},
  year = {2020},
  volume = {17},
  number = {5},
  pages = {567--569},
  doi = {10.1177/1740774520941420},
  url = {https://www.scopus.com/inward/record.uri?eid=2-s2.0-85087994668\&doi=10.1177%2f1740774520941420\&partnerID=40\&md5=e15ddbbe730ed45209996c9e407b1a47}
}

@ARTICLE{kunz2020ctib461474,
  author = {Kunz, C.U.~ and J{\"o}rgens, S.~ and Bretz, F.~ and Stallard, N.~ and Van Lancker, K.~ and Xi, D.~ and Zohar, S.~ and Gerlinger, C.~ and Friede, T.~},
  title = {Clinical Trials Impacted by the COVID-19 Pandemic: Adaptive Designs to the Rescue?},
  journal = {Statistics in Biopharmaceutical Research},
  year = {2020},
  volume = {12},
  number = {4},
  pages = {461--474},
  doi = {10.1080/19466315.2020.1799857},
  url = {https://www.scopus.com/inward/record.uri?eid=2-s2.0-85089499787\&doi=10.1080%2f19466315.2020.1799857\&partnerID=40\&md5=d271a8fb6e6276808846f622c62ba12b}
}

@ARTICLE{zame2020mlct506517,
  author = {Zame, W.R.~ and Bica, I.~ and Shen, C.~ and Curth, A.~ and Lee, H.-S.~ and Bailey, S.~ and Weatherall, J.~ and Wright, D.~ and Bretz, F.~ and van der Schaar, M.~},
  title = {Machine Learning for Clinical Trials in the Era of COVID-19.},
  journal = {Statistics in Biopharmaceutical Research},
  year = {2020},
  volume = {12},
  number = {4},
  pages = {506--517},
  doi = {10.1080/19466315.2020.1797867},
  url = {https://www.scopus.com/inward/record.uri?eid=2-s2.0-85089556872\&doi=10.1080%2f19466315.2020.1797867\&partnerID=40\&md5=c8386ca4bca3f5947533603ca88841b0}
}

@ARTICLE{moellenhoff2020ercs518529,
  author = {M{\"o}llenhoff, K.~ and Bretz, F.~ and Dette, H.~},
  title = {Equivalence of Regression Curves Sharing Common Parameters.},
  journal = {Biometrics},
  year = {2020},
  volume = {76},
  number = {2},
  pages = {518--529},
  issn = {0006-341X},
  doi = {10.1111/biom.13149},
  url = {https://doi.org/10.1111/biom.13149},
  keywords = {equivalence testing;dose-finding studies;nonlinear regression;parametric bootstrap;similarity of regression curves}
}

@ARTICLE{xi2019sgew52685282,
  author = {Xi, D.~ and Bretz, F.~},
  title = {Symmetric Graphs for Equally Weighted Tests, with Application to the Hochberg Procedure.},
  journal = {Statistics in Medicine},
  year = {2019},
  volume = {38},
  number = {27},
  pages = {5268--5282},
  issn = {0277-6715},
  doi = {10.1002/sim.8375},
  keywords = {multiple testing;closed test procedure;framework;bonferroni procedure;component graph;familywise error rate;graphical approach;holm procedure;hypotheses;mixture;rejective multiple test;simes;weighting scheme}
}

@ARTICLE{posch2019qaud11031103,
  author = {Posch, M.~ and Bretz, F.~ and Friede, T.~ and Heinze, G.~},
  title = {Quantitative Approaches Underpinning Decision Making.},
  journal = {Biometrical Journal},
  year = {2019},
  volume = {61},
  number = {5: Special Issue: CEN-ISBS Vienna 2017, Vienna, Austria, 28 August–1 September 2017},
  pages = {1103},
  note = {[Editorial]},
  doi = {10.1002/bimj.201900202},
  url = {https://www.scopus.com/inward/record.uri?eid=2-s2.0-85071713081\&doi=10.1002%2fbimj.201900202\&partnerID=40\&md5=878ee760b9fcbd5b52afea354781a827}
}

@ARTICLE{liu2019cssc24,
  author = {Liu, W.~ and Bretz, F.~ and Srimaneekarn, N.~ and Peng, J.~ and Hayter, A.J.~},
  title = {Confidence Sets for Statistical Classification.},
  journal = {Stats},
  year = {2019},
  volume = {2},
  number = {3},
  pages = {24},
  issn = {2571-905X},
  doi = {10.3390/stats2030024},
  keywords = {classification;confidence level;confidence set;coverage frequency;simultaneous tolerance intervals;statistical inference}
}

@ARTICLE{gómezmelis2019atbe243244,
  author = {Gómez Melis, G.~ and Bretz, F.~ and de Uña Álvarez, J.~},
  title = {Advanced Topics in Biostatistics: Editorial for the ISCB38 Special Issue.},
  journal = {Biometrical Journal},
  year = {2019},
  volume = {61},
  number = {2},
  pages = {243--244},
  issn = {1521-4036 0323-3847},
  doi = {10.1002/bimj.201900059}
}

@ARTICLE{sugitani2018faas33873402,
  author = {Sugitani, T.~ and Posch, M.~ and Bretz, F.~ and Koenig, F.~},
  title = {Flexible Alpha Allocation Strategies for Confirmatory Adaptive Enrichment Clinical Trials with a Prespecified Subgroup.},
  journal = {Statistics in Medicine},
  year = {2018},
  volume = {37},
  number = {24},
  pages = {3387--3402},
  issn = {1097-0258 0277-6715},
  doi = {10.1002/sim.7851},
  keywords = {subgroup analysis;adaptive enrichment design;closed testing procedure;combination test;feedback procedure;partial conditional error rate}
}

@ARTICLE{gibson2018kamq283296,
  author = {Gibson, E.~ and Bretz, F.~ and Looby, M.~ and Bornkamp, B.~},
  title = {Key Aspects of Modern, Quantitative Drug Development.},
  journal = {Statistics in Biosciences},
  year = {2018},
  volume = {10},
  number = {2},
  pages = {283--296},
  doi = {10.1007/s12561-017-9203-2},
  url = {https://www.scopus.com/inward/record.uri?eid=2-s2.0-85046783550\&doi=10.1007%2fs12561-017-9203-2\&partnerID=40\&md5=53fb8954fceec735bf11748ee781aefd}
}

@ARTICLE{bretz2018asdr722738,
  author = {Bretz, F.~ and M{\"o}llenhoff, K.~ and Dette, H.~ and Liu, W.~ and Trampisch, M.~},
  title = {Assessing the Similarity of Dose Response and Target Doses in Two Non-Overlapping Subgroups.},
  journal = {Statistics in Medicine},
  year = {2018},
  volume = {37},
  number = {5},
  pages = {722--738},
  issn = {1097-0258 0277-6715},
  doi = {10.1002/sim.7546},
  keywords = {subgroup analysis;dose finding;equivalence testing;target dose estimation}
}

@ARTICLE{akacha2017etrc268271,
  author = {Akacha, M.~ and Bretz, F.~ and Ohlssen, D.~ and Rosenkranz, G.~ and Schmidli, H.~},
  title = {Estimands and Their Role in Clinical Trials.},
  journal = {Statistics in Biopharmaceutical Research},
  year = {2017},
  volume = {9},
  number = {3},
  pages = {268--271},
  doi = {10.1080/19466315.2017.1302358},
  url = {https://www.scopus.com/inward/record.uri?eid=2-s2.0-85029930170\&doi=10.1080%2f19466315.2017.1302358\&partnerID=40\&md5=8beb6e27305b330227b6f16b0940108a}
}

@INCOLLECTION{bretz2017mtsc279290,
  author = {Bretz, F.~ and Bornkamp, B.~ and K{\"o}nig, F.~},
  title = {Multiple Test Strategies for Comparing Several Doses with a Control in Confirmatory Trials.},
  booktitle = {Handbook of Methods for Designing, Monitoring, and Analyzing Dose-Finding Trials},
  publisher = {Chapman \& Hall/CRC},
  year = {2017},
  editor = {O’Quigley,J.;Iasonos,A.;Bornkamp,B.},
  series = {Handbooks of Modern Statistical Methods},
  pages = {279--290},
  address = {Boca Raton},
  url = {https://www.crcpress.com/Handbook-of-Methods-for-Designing-Monitoring-and-Analyzing-Dose-Finding/OQuigley-Iasonos-Bornkamp/p/book/9780367330682}
}

@ARTICLE{musuamba2017amdr418429,
  author = {Musuamba, F. T.~ and Manolis, E.~ and Holford, N.~ and Cheung, S.Y.A.~ and Friberg, L.E.~ and Ogungbenro, K.~ and Posch, M.~ and Yates, J.W.T.~ and Berry, S.~ and Thomas, N.~ and Corriol-Rohou, S.~ and Bornkamp, B.~ and Bretz, F.~ and Hooker, A.C.~ and Van der Graaf, P.H.~ and Standing, J.F.~ and Hay, J.~ and Cole, S.~ and Gigante, V.~ and Karlsson, K.~ and Dumortier, T.~ and Benda, N.~ and Serone, F.~ and Das, S.~ and Brochot, A.~ and Ehmann, F.~ and Hemmings, R.~ and Rusten, I.S.~},
  title = {Advanced Methods for Dose and Regimen Finding during Drug Development: Summary of the EMA/EFPIA Workshop on Dose Finding (London 4–5 December 2014).},
  journal = {CPT: Pharmacometrics \& Systems Pharmacology},
  year = {2017},
  volume = {6},
  number = {7},
  pages = {418--429},
  issn = {2163-8306 2163-8306},
  doi = {10.1002/psp4.12196},
  keywords = {Animals;Humans;Clinical Trials as Topic;*Dose-Response Relationship;Drug;*Drug Discovery;*Models;Theoretical;Pharmaceutical Preparations/administration \& dosage;Research Design}
}

@ARTICLE{alosh2017tscs13341360,
  author = {Alosh, M.~ and Huque, M.F.~ and Bretz, F.~ and D’Agostino Sr., R.B.~},
  title = {Tutorial on Statistical Considerations on Subgroup Analysis in Confirmatory Clinical Trials.},
  journal = {Statistics in Medicine},
  year = {2017},
  volume = {36},
  number = {8},
  pages = {1334--1360},
  issn = {1097-0258 0277-6715},
  doi = {10.1002/sim.7167},
  keywords = {Humans;Reproducibility of Results;Models;Statistical;Treatment Outcome;*Data Interpretation;Statistical;*negative subgroup treatment effect;*Randomized Controlled Trials as Topic/methods;*supportive subgroup findings;*targeted subgroup;*treatment-by-subgroup interaction;Aspirin/therapeutic use;Myocardial Infarction/prevention \& control;Protein C/therapeutic use;Recombinant Proteins/therapeutic use;Sepsis/drug therapy/mortality;Statistics as Topic;Stroke/prevention \& control;Survival Analysis;Ticlopidine/analogs \& derivatives/therapeutic use;Clopidogrel}
}

@ARTICLE{eichler2016tauw699712,
  author = {Eichler, H.-G.~ and Bloechl-Daum, B.~ and Bauer, P.~ and Bretz, F.~ and Brown, J.~ and Hampson, L. V.~ and Honig, P.~ and Krams, M.~ and Leufkens, H.~ and Lim, R.~ and Lumpkin, M. M.~ and Murphy, M. J.~ and Pignatti, F.~ and Posch, M.~ and Schneeweiss, S.~ and Trusheim, M.~ and Koenig, F.~},
  title = {“Threshold-Crossing”: A Useful Way to Establish the Counterfactual in Clinical Trials?},
  journal = {Clinical Pharmacology and Therapeutics},
  year = {2016},
  volume = {100},
  number = {6},
  pages = {699--712},
  issn = {1532-6535 0009-9236},
  doi = {10.1002/cpt.515},
  keywords = {Humans;Models;Theoretical;Treatment Outcome;*Research Design;Randomized Controlled Trials as Topic/*methods;Pharmaceutical Preparations/*administration \& dosage}
}

@ARTICLE{eldridge2016c2sei5239,
  author = {Eldridge, S.M.~ and Chan, C.L.~ and Campbell, M.J.~ and Bond, C.M.~ and Hopewell, S.~ and Thabane, L.~ and Lancaster, G.A.~ and {on Behalf of the PAFS Consensus Group}},
  title = {CONSORT 2010 Statement: Extension to Randomised Pilot and Feasibility Trials.},
  journal = {BMJ},
  year = {2016},
  volume = {355},
  number = {8079},
  pages = {i5239},
  issn = {1756-1833 0959-8138},
  doi = {10.1136/bmj.i5239},
  keywords = {Humans;*Pilot Projects;*Practice Guidelines as Topic;Randomized Controlled Trials as Topic/*standards;*Feasibility Studies;Periodicals as Topic/standards;Quality Improvement/standards}
}

@ARTICLE{eldridge2016c2se64,
  author = {Eldridge, S.M.~ and Chan, C.L.~ and Campbell, M.J.~ and Bond, C.M.~ and Hopewell, S.~ and Thabane, L.~ and Lancaster, G.A.~ and {on Behalf of the PAFS Consensus Group}},
  title = {CONSORT 2010 Statement: Extension to Randomised Pilot and Feasibility Trials.},
  journal = {Pilot and Feasibility Studies},
  year = {2016},
  volume = {2},
  pages = {64},
  doi = {10.1186/s40814-016-0105-8},
  url = {https://www.scopus.com/inward/record.uri?eid=2-s2.0-85041078754\&doi=10.1186%2fs40814-016-0105-8\&partnerID=40\&md5=5503a2974427ae8eb8ca89ea2aec69cf}
}

@ARTICLE{sugitani2016asfg202216,
  author = {Sugitani, T.~ and Bretz, F.~ and Maurer, W.~},
  title = {A Simple and Flexible Graphical Approach for Adaptive Group-Sequential Clinical Trials.},
  journal = {Journal of Biopharmaceutical Statistics},
  year = {2016},
  volume = {26},
  number = {2},
  pages = {202--216},
  issn = {1520-5711 1054-3406},
  doi = {10.1080/10543406.2014.972509},
  keywords = {Algorithms;Humans;Models;Statistical;Adaptive design;Sample Size;sample size reassessment;group-sequential design;*Computer Graphics;Research Design/*statistics \& numerical data;*Clinical Trials as Topic/methods/statistics \& numerical data;closed test procedure;inverse normal combination test}
}

@ARTICLE{bauer2016tyca325347,
  author = {Bauer, P.~ and Bretz, F.~ and Dragalin, V.~ and K{\"o}nig, F.~ and Wassmer, G.~},
  title = {Twenty-Five Years of Confirmatory Adaptive Designs: Opportunities and Pitfalls.},
  journal = {Statistics in Medicine},
  year = {2016},
  volume = {35},
  number = {3},
  pages = {325--347},
  issn = {1097-0258 0277-6715},
  doi = {10.1002/sim.6472},
  keywords = {Humans;clinical trials;Data Interpretation;Statistical;*Research Design;adaptive design;group sequential designs;Software Design;*Sample Size;Clinical Trials as Topic/methods/*statistics \& numerical data;*Meta-Analysis as Topic;Biometry/*methods;Endpoint Determination/methods/statistics \& numerical data}
}

@ARTICLE{bauer2016artc364367,
  author = {Bauer, P.~ and Bretz, F.~ and Dragalin, V.~ and K{\"o}nig, F.~ and Wassmer, G.~},
  title = {Authors’ Response to Comments.},
  journal = {Statistics in Medicine},
  year = {2016},
  volume = {35},
  number = {3},
  pages = {364--367},
  note = {[Correspondence] [Re Re Re Re]},
  issn = {1097-0258 0277-6715},
  doi = {10.1002/sim.6823}
}

@ARTICLE{liu2015m8ic57,
  author = {Liu, W.~ and Bretz, F.~ and Hsu, J.C.~ and Posch, M.~},
  title = {MCP2013 – 8th International Conference on Multiple Comparison Procedures.},
  journal = {Biometrical Journal},
  year = {2015},
  volume = {57},
  number = {1: Special Issue: Multiple Comparison Procedures 2013 – 8th International Conference, Southampton, UK, 8–11 July 2013  },
  pages = {5--7},
  note = {[Editorial]},
  issn = {1521-4036 0323-3847},
  doi = {10.1002/bimj.201400215},
  keywords = {*Statistics as Topic}
}

@ARTICLE{koenig2013jeid16191620,
  author = {Koenig, F.~ and Bretz, F.~},
  title = {Joint EMA, ISBS, and DR-IBS International Symposium on Biopharmaceutical Statistics: Bridging Drug Development from Research to Marketing.},
  journal = {Statistics in Medicine},
  year = {2013},
  volume = {32},
  number = {107: Special Issue: Second International Symposium on Biopharmaceutical Statistics, Berlin, Germany, 1–3 March 2011},
  pages = {1619--1620},
  note = {[Editorial]},
  issn = {1097-0258 0277-6715},
  doi = {10.1002/sim.5739},
  keywords = {Humans;Marketing;*Biostatistics;Biopharmaceutics/*statistics \& numerical data;Drug Discovery/statistics \& numerical data}
}

@ARTICLE{bretz2013ar266266,
  author = {Bretz, F.~ and Posch, M.~ and Glimm, E.~ and Klinglmueller, F.~ and Maurer, W.~ and Rohmeyer, K.~},
  title = {Author’s Reply.},
  journal = {Biometrical Journal},
  year = {2013},
  volume = {55},
  number = {2},
  pages = {266},
  note = {[Correspondence] [Re]},
  issn = {1521-4036 0323-3847},
  doi = {10.1002/bimj.201200256},
  keywords = {Humans;Clinical Trials as Topic/*methods;*Computer Graphics;Biometry/*methods}
}

@ARTICLE{bretz2011gamc894913,
  author = {Bretz, F.~ and Posch, M.~ and Glimm, E.~ and Klinglmueller, F.~ and Maurer, W.~ and Rohmeyer, K.~},
  title = {Graphical Approaches for Multiple Comparison Procedures Using Weighted Bonferroni, Simes, or Parametric Tests.},
  journal = {Biometrical Journal},
  year = {2011},
  volume = {53},
  number = {6},
  pages = {894--913},
  issn = {1521-4036 0323-3847},
  doi = {10.1002/bimj.201000239},
  keywords = {Algorithms;Humans;Goals;Clinical Trials as Topic/*methods;*Computer Graphics;Biometry/*methods}
}

@ARTICLE{posch2011tier96104,
  author = {Posch, M.~ and Maurer, W.~ and Bretz, F.~},
  title = {Type I Error Rate Control in Adaptive Designs for Confirmatory Clinical Trials with Treatment Selection at Interim.},
  journal = {Pharmaceutical Statistics},
  year = {2011},
  volume = {10},
  number = {2},
  pages = {96--104},
  issn = {1539-1612 1539-1604},
  doi = {10.1002/pst.413},
  keywords = {Humans;*Research Design;Computer Simulation;Sample Size;*Clinical Trials as Topic}
}

@ARTICLE{hirotsu2010m6ic705707,
  author = {Hirotsu, C.~ and Posch, M.~ and Bretz, F.~},
  title = {MCP2009 – 6th International Conference on Multiple Comparison Procedures.},
  journal = {Biometrical Journal},
  year = {2010},
  volume = {52},
  number = {6: Special Issue: MCP2009, Tokyo, Japan, 24–27 March 2009},
  pages = {705--707},
  note = {[Editorial]},
  issn = {0323-3847},
  doi = {10.1002/bimj.201000195},
  url = {https://doi.org/10.1002/bimj.201000195}
}

@ARTICLE{benda2010puad10981112,
  author = {Benda, N.~ and Brannath, W.~ and Bretz, F.~ and Burger, H.-U.~ and Friede, T.~ and Maurer, W.~ and Wang, S.-J.~},
  title = {Perspectives on the Use of Adaptive Designs in Clinical Trials. Part II. Panel Discussion.},
  journal = {Journal of Biopharmaceutical Statistics},
  year = {2010},
  volume = {20},
  number = {6},
  pages = {1098--1112},
  issn = {1520-5711 1054-3406},
  doi = {10.1080/10543406.2010.514447},
  keywords = {Humans;Reproducibility of Results;Models;Statistical;Treatment Outcome;Data Interpretation;Statistical;*Research Design;United States;Guidelines as Topic;Clinical Trials as Topic/*methods/statistics \& numerical data;Drug Approval/*methods}
}

@ARTICLE{brannath2010slcc660669,
  author = {Brannath, W.~ and Bretz, F.~},
  title = {Shortcuts for Locally Consonant Closed Test Procedures.},
  journal = {Journal of the American Statistical Association},
  year = {2010},
  volume = {105},
  number = {490},
  pages = {660--669},
  doi = {10.1198/jasa.2010.tm08127},
  url = {https://www.scopus.com/inward/record.uri?eid=2-s2.0-78649408861\&doi=10.1198%2fjasa.2010.tm08127\&partnerID=40\&md5=cebf76a4b267d8a2fc49857f128133e7}
}

@ARTICLE{brannath2009twst885898,
  author = {Brannath, W.~ and Bretz, F.~ and Maurer, W.~ and Sarkar, S.~},
  title = {Trimmed Weighted Simes’ Test for Two One-Sided Hypotheses with Arbitrarily Correlated Test Statistics.},
  journal = {Biometrical Journal},
  year = {2009},
  volume = {51},
  number = {6},
  pages = {885--898},
  issn = {1521-4036 0323-3847},
  doi = {10.1002/bimj.200900132},
  keywords = {*Algorithms;*Models;Biological;Confidence Intervals;Computer Simulation;Sample Size;*Logistic Models;*Models;Statistical;*Data Interpretation;Statistical;Statistics as Topic;Regression Analysis;Statistical Distributions;*Artifacts;Biometry/*methods;Numerical Analysis;Computer-Assisted}
}

@INPROCEEDINGS{posch2009itie iwsm08pdf,
  author = {Posch, M.~ and Maurer, W.~ and Bretz, F.~},
  title = {Issues in Type I Error Rate Control in Adaptive Clinical Trials with Treatment Selection.},
  booktitle = {Proceedings (on CD-ROM) of the Second International Workshop in Sequential Methodologies (IWSM 2009), Troyes, France, 15–17 June 2009},
  year = {2009},
  pages = { IWSM08.pdf},
  address = {Troyes, France},
  organization = {University of Technology of Troyes},
  url = {http://mat.izt.uam.mx/profs/anovikov/data/IWSM2009/invited%20papers/IWSM08.pdf}
}

@ARTICLE{brannath2009cadw14451463,
  author = {Brannath, W.~ and Zuber, E.~ and Branson, M.~ and Bretz, F.~ and Gallo, P.~ and Posch, M.~ and Racine-Poon, A.~},
  title = {Confirmatory Adaptive Designs with Bayesian Decision Tools for a Targeted Therapy in Oncology.},
  journal = {Statistics in Medicine},
  year = {2009},
  volume = {28},
  number = {10},
  pages = {1445--1463},
  issn = {0277-6715 0277-6715},
  doi = {10.1002/sim.3559},
  keywords = {Humans;Models;Statistical;Likelihood Functions;Bayes Theorem;Decision Support Techniques;Patient Selection;Clinical Trials as Topic/*statistics \& numerical data;Biometry/methods;Clinical Trials;Phase II as Topic/statistics \& numerical data;Clinical Trials;Phase III as Topic/statistics \& numerical data;Neoplasms/*therapy}
}

@ARTICLE{bretz2009adcc11811217,
  author = {Bretz, F.~ and Koenig, F.~ and Brannath, W.~ and Glimm, E.~ and Posch, M.~},
  title = {Adaptive Designs for Confirmatory Clinical Trials.},
  journal = {Statistics in Medicine},
  year = {2009},
  volume = {28},
  number = {8},
  pages = {1181--1217},
  note = {[Tutorial]},
  issn = {0277-6715 0277-6715},
  doi = {10.1002/sim.3538},
  keywords = {Humans;*Research Design;Computer Simulation;Sample Size;Clinical Trials;Phase II as Topic/*methods;Clinical Trials;Phase III as Topic/*methods;Anti-Anxiety Agents/therapeutic use;Anxiety Disorders/drug therapy}
}

@ARTICLE{bretz2009agat586604,
  author = {Bretz, F.~ and Maurer, W.~ and Brannath, W.~ and Posch, M.~},
  title = {A Graphical Approach to Sequentially Rejective Multiple Test Procedures.},
  journal = {Statistics in Medicine},
  year = {2009},
  volume = {28},
  number = {4},
  pages = {586--604},
  issn = {0277-6715 0277-6715},
  doi = {10.1002/sim.3495},
  keywords = {Algorithms;Humans;Confidence Intervals;*Models;Statistical;*Data Interpretation;Statistical;Markov Chains;Clinical Trials as Topic/*methods;*Computer Graphics;Biometry/*methods}
}

@ARTICLE{koenig2008adtt16121625,
  author = {Koenig, F.~ and Brannath, W.~ and Bretz, F.~ and Posch, M.~},
  title = {Adaptive Dunnett Tests for Treatment Selection.},
  journal = {Statistics in Medicine},
  year = {2008},
  volume = {27},
  number = {10},
  pages = {1612--1625},
  issn = {0277-6715 0277-6715},
  doi = {10.1002/sim.3048},
  keywords = {Humans;*Research Design;Computer Simulation;Bias;Clinical Trials as Topic/*methods;Clinical Trials;Phase II as Topic/methods;Clinical Trials;Phase III as Topic/methods}
}

@ARTICLE{bornkamp2007iada965995,
  author = {Bornkamp, B.~ and Bretz, F.~ and Dmitrienko, A.~ and Enas, G.~ and Gaydos, B.~ and Hsu, C.-H.~ and K{\"o}nig, F.~ and Krams, M.~ and Liu, Q.~ and Neuenschwander, B.~ and Parke, T.~ and Pinheiro, J.~ and Roy, A.~ and Sax, R.~ and Shen, F.~},
  title = {Innovative Approaches for Designing and Analyzing Adaptive Dose-Ranging Trials.},
  journal = {Journal of Biopharmaceutical Statistics},
  year = {2007},
  volume = {17},
  number = {6},
  pages = {965--995},
  issn = {1054-3406 1054-3406},
  doi = {10.1080/10543400701643848},
  keywords = {Humans;Dose-Response Relationship;Drug;*Research Design;Sample Size;*Data Interpretation;Statistical;Clinical Trials as Topic/*methods/statistics \& numerical data;*Drug Industry}
}

@INPROCEEDINGS{brannath2007agps5454,
  author = {Brannath, W.~ and Bretz, F.~},
  title = {A General Principle for Shortening Closed Test Procedures with Applications.},
  booktitle = {MCP 2007 – Vienna, 5th International Conference on Multiple Comparison Procedures, Vienna, Austria, 8–11 July 2007, Program and Abstracts},
  year = {2007},
  editor = {Posch,M.;Hsu,J.;K{\"o}nig,F.},
  pages = {54},
  address = {Vienna, Austria},
  publisher = {Section of Medical Statistics, Medical University of Vienna},
  url = {http://www.mcp-conference.org/2007/downloads/MCP_2007_AbstractBook.pdf#page=56}
}

@INPROCEEDINGS{zuber2007asds111111,
  author = {Zuber, E.~ and Brannath, W.~ and Branson, M.~ and Bretz, F.~ and Gallo, P.~ and Posch, M.~ and Racine, A.~},
  title = {Adaptive Seamless Designs for Subpopulation Selection Based on Time to Event Endpoints.},
  booktitle = {MCP 2007 – Vienna, 5th International Conference on Multiple Comparison Procedures, Vienna, Austria, 8–11 July 2007, Program and Abstracts},
  year = {2007},
  editor = {Posch,M.;Hsu,J.;K{\"o}nig,F.},
  pages = {111},
  address = {Vienna, Austria},
  publisher = {Section of Medical Statistics, Medical University of Vienna},
  url = {http://www.mcp-conference.org/2007/downloads/MCP_2007_AbstractBook.pdf#page=113}
}

@ARTICLE{bretz2006cspi623634,
  author = {Bretz, F.~ and Schmidli, H.~ and K{\"o}nig, F.~ and Racine, A.~ and Maurer, W.~},
  title = {Confirmatory Seamless Phase II/III Clinical Trials with Hypotheses Selection at Interim: General Concepts.},
  journal = {Biometrical Journal},
  year = {2006},
  volume = {48},
  number = {4},
  pages = {623--634},
  issn = {0323-3847 0323-3847},
  doi = {10.1002/bimj.200510232},
  keywords = {Data Interpretation;Statistical;Sample Size;Clinical Trials;Phase III as Topic/*statistics \& numerical data;*Biometry;Clinical Trials;Phase II as Topic/*statistics \& numerical data}
}

@ARTICLE{bretz2006r660662,
  author = {Bretz, F.~ and Schmidli, H.~ and K{\"o}nig, F.~ and Racine, A.~ and Maurer, W.~},
  title = {Rejoinder.},
  journal = {Biometrical Journal},
  year = {2006},
  volume = {48},
  number = {4},
  pages = {660--662},
  note = {[Correspondence] [Re Re Re]},
  issn = {0323-3847},
  doi = {10.1002/bimj.200610255},
  url = {https://doi.org/10.1002/bimj.200610255},
  keywords = {Multiple testing;Closure principle;Adaptive seamless design;Adaptive tests;Combination tests;Hypotheses selection}
}