Götte H - Search Results

1

Capecitabine and cisplatin with or without cetuximab for patients with previously untreated advanced gastric cancer (EXPAND): a randomised, open-label phase 3 trial.

Lordick F, Kang YK, Chung HC, Salman P, Oh SC, Bodoky G, Kurteva G, Volovat C, Moiseyenko VM, Gorbunova V, Park JO, Sawaki A, Celik I, Götte H, Melezínková H, Moehler M; Arbeitsgemeinschaft Internistische Onkologie and EXPAND Investigators. Lordick F, et al. Among authors: gotte h. Lancet Oncol. 2013 May;14(6):490-9. doi: 10.1016/S1470-2045(13)70102-5. Epub 2013 Apr 15. Lancet Oncol. 2013. PMID: 23594786 Clinical Trial.

2

Progression-free survival in oncological clinical studies: Assessment time bias and methods for its correction.

Miltenberger R, Götte H, Schüler A, Jahn-Eimermacher A. Miltenberger R, et al. Among authors: gotte h. Pharm Stat. 2021 Jul;20(4):864-878. doi: 10.1002/pst.2115. Epub 2021 Mar 29. Pharm Stat. 2021. PMID: 33783071

3

Sample size planning for phase II trials based on success probabilities for phase III.

Götte H, Schüler A, Kirchner M, Kieser M. Götte H, et al. Pharm Stat. 2015 Nov-Dec;14(6):515-24. doi: 10.1002/pst.1717. Epub 2015 Sep 28. Pharm Stat. 2015. PMID: 26412484

4

Delayed treatment effects, treatment switching and heterogeneous patient populations: How to design and analyze RCTs in oncology.

Ristl R, Ballarini NM, Götte H, Schüler A, Posch M, König F. Ristl R, et al. Among authors: gotte h. Pharm Stat. 2021 Jan;20(1):129-145. doi: 10.1002/pst.2062. Epub 2020 Aug 23. Pharm Stat. 2021. PMID: 32830428 Free PMC article.

5

Utility-based optimization of phase II/III programs.

Kirchner M, Kieser M, Götte H, Schüler A. Kirchner M, et al. Among authors: gotte h. Stat Med. 2016 Jan 30;35(2):305-16. doi: 10.1002/sim.6624. Epub 2015 Aug 9. Stat Med. 2016. PMID: 26256550

6

An adaptive design for early clinical development including interim decision for single-arm trial with external controls or randomized trial.

Götte H, Kirchner M, Krisam J, Allignol A, Lamy FX, Schüler A, Kieser M. Götte H, et al. Pharm Stat. 2022 May;21(3):625-640. doi: 10.1002/pst.2190. Epub 2022 Jan 21. Pharm Stat. 2022. PMID: 35060676 Clinical Trial.

7

Robust group sequential designs for trials with survival endpoints and delayed response.

Ghosh P, Ristl R, König F, Posch M, Jennison C, Götte H, Schüler A, Mehta C. Ghosh P, et al. Among authors: gotte h. Biom J. 2022 Feb;64(2):343-360. doi: 10.1002/bimj.202000169. Epub 2021 Dec 21. Biom J. 2022. PMID: 34935177

8

Sample size planning for survival prediction with focus on high-dimensional data.

Götte H, Zwiener I. Götte H, et al. Stat Med. 2013 Feb 28;32(5):787-807. doi: 10.1002/sim.5550. Epub 2012 Aug 1. Stat Med. 2013. PMID: 22859340

9

Optimal decision-making in oncology development programs based on probability of success for phase III utilizing phase II/III data on response and overall survival.

Götte H, Xiong J, Kirchner M, Demirtas H, Kieser M. Götte H, et al. Pharm Stat. 2020 Nov;19(6):861-881. doi: 10.1002/pst.2042. Epub 2020 Jul 14. Pharm Stat. 2020. PMID: 32662598

10

Simulation-based adjustment after exploratory biomarker subgroup selection in phase II.

Götte H, Kirchner M, Sailer MO, Kieser M. Götte H, et al. Stat Med. 2017 Jul 10;36(15):2378-2390. doi: 10.1002/sim.7294. Epub 2017 Apr 24. Stat Med. 2017. PMID: 28436046

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