Publications | Kaspar Rufibach

Alexandra Erdmann, Jan Beyersmann, Kaspar Rufibach (2023). Oncology clinical trial design planning based on a multistate model that jointly models progression-free and overall survival endpoints. Submitted.

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Letizia Polito, Qixing Liang, Navdeep Pal, Philani Mpofu, Ahmed Sawas, Olivier Humblet, Kaspar Rufibach, Dominik Heinzmann (2023). Applying the Estimand and Target Trial frameworks to external control analyses using observational data: a case study in the solid tumor setting. Submitted.

arxiv

Kaspar Rufibach, Lynda Grinsted, Jiang Li, Hans Jochen Weber, Cheng Zheng, Jiangxiu Zhou (2023). Quantification of follow-up time in oncology clinical trials with a time-to-event endpoint: Asking the right questions. Pharm. Stat., to appear.

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Kaspar Rufibach, Regina Stegherr, Claudia Schmoor, Valentine Jehl, Arthur Allignol, Annette Boeckenhoff, Cornelia Dunger-Baldauf, Lewin Eisele, Thomas Künzel, Katrin Kupas, Friedhelm Leverkus, Matthias Trampisch, Yumin Zhao, Tim Friede, Jan Beyersmann (2022). Survival analysis for AdVerse events with VarYing follow-up times (SAVVY) - comparison of adverse event risks in randomized controlled trials. Statistics in Biopharmaceutical Research, accepted. *The first two authors contributed equally to this paper.

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Rajeshwari Sridhara, Elizabeth Barksdale, Olga Marchenko, Qi Jiang, Yuki Ando, Erick Bloomquist, Michael Coory, Melissa Crouse, Evgeny Degtyarev, Theodor Framke, Boris Freidlin, David E. Gerber, Thomas Gwise, Filip Josephson, Lorenzo Hess, Paul Kluetz, Daniel Li, Sumithra Mandrekar, Martin Posch, Khadija Rantell, Bohdana Ratitch, Andrew Raven, Kit Roes, Kaspar Rufibach, Sinan B Sarac, Richard Simon, Harpreet Singh, Marc Theoret, Andrew Thomson, Emmanuel Zuber, Yuan Li Shen, Richard Pazdur (2022). Cancer Clinical Trials Beyond Pandemic: Report of an American Statistical Association Biopharmaceutical Section Open Forum Discussion. Statistics in Biopharmaceutical Research, accepted.

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Alexei C. Ionan, Miya Paterniti, Devan V. Mehrotra, John Scott, Bohdana Ratitch, Sylva Collins, Shanti Gomatam, Lei Nie, Kaspar Rufibach, Frank Bretz (2022). Clinical and Statistical Perspectives on the Estimand Framework Implementation. Statistics in Biopharmaceutical Research, accepted.

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Olivier Collignon, Anja Schiel, Carl-Fredrik Burman, Kaspar Rufibach, Martin Posch, Frank Bretz (2022). Estimands and Complex Innovative Designs. Clinical Pharmacology & Therapeutics, 112(6), 1183–1190.

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Kevin Kunzmann, Michael J. Grayling, Kim May Lee, David S. Robertson, Kaspar Rufibach, James M. S. Wason (2022). Conditional Power and Friends: The Why and How of (Un)planned, Unblinded Sample Size Recalculations in Confirmatory Trials. Stat. Med., 41(5), 877-890.

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Juliane Manitz, Natalia Kan-Dobrosky, Hannes Buchner, Marie-Laure Casadebaig, Evgeny Degtyarev, Jyotirmoy Dey, Vincent Haddad, Jie Fei, Emily Martin, Mindy Mo, Kaspar Rufibach, Yue Shentu, Viktoriya Stalbovskaya, Tang Rui, Godwin Yung, Jiangxiu Zhu (2022). Estimands for Overall Survival in Clinical Trials with Treatment Switching in Oncology. Pharm. Stat., 21, 150-162.

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Regina Stegherr, Claudia Schmoor, Jan Beyersmann, Kaspar Rufibach, Valentine Jehl, Andreas Brückner, Lewin Eisele, Thomas Künzel, Katrin Kupas, Frank Langer, Friedhelm Leverkus, Anja Loos, Christiane Norenberg, Florian Voss, Tim Friede (2021). Survival analysis for AdVerse events with VarYing follow-up times (SAVVY): Estimation of adverse event risks. Trials, 22(1), 420.

Preprint PDF Code Project Video arxiv

Kevin Kunzmann, Michael J. Grayling, Kim May Lee, David S. Robertson, Kaspar Rufibach, James M. S. Wason (2021). A review of Bayesian perspectives on sample size derivation for confirmatory trials. Am. Stat., 75(4), 424–432.

PDF arxiv Code on github Shiny app for sample size calculation

Björn Bornkamp, Kaspar Rufibach, Jianchang Lin, Yi Liu, Devan Mehrotra, Satrajit Roychoudhury, Heinz Schmidli, Yue Shentu, Marcel Wolbers (2021). Principal Stratum Strategy: Potential Role in Drug Development. Pharm. Stat., 20, 737-751.

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Steven Sun, Hans-Jochen Weber, Emily Butler, Kaspar Rufibach, Satrajit Roychoudhury (2021). Estimands in Hematology Trials. Pharm. Stat., 20, 793-805.

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Regina Stegherr, Jan Beyersmann, Valentine Jehl, Kaspar Rufibach, Friedhelm Leverkus, Claudia Schmoor, Tim Friede (2021). Survival analysis for AdVerse events with VarYing follow-up times (SAVVY): Rationale and statistical concept of a meta-analytic study. Biom. J., 63, 650–670.

Preprint PDF Code Project

Rachael Lawrance, Evgeny Degtyarev, Philip Griffiths, Peter Trask, Helen Lau, Denise D’Alessio, Ingolf Griebsch, Gudrun Wallenstein, Kim Cocks, Kaspar Rufibach (2020). What is an estimand & how does it relate to quantifying the effect of treatment on patient-reported quality of life outcomes in clinical trials?. J Patient Rep Outcomes, 4:68.

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Evgeny Degtyarev, Kaspar Rufibach, Yue Shentu, Godwin Yung, Michelle Casey, Stefan Englert, Feng Liu, Yi Liu, Oliver Sailer, Jonathan Siegel, Steven Sun, Rui Tang, Jiangxiu Zhou (2020). Assessing the impact of COVID-19 on the objective and analysis of oncology clinical trials - application of the estimand framework. Statistics in Biopharmaceutical Research, 12(4), 427-437. *The first four authors contributed equally to this paper.

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Kaspar Rufibach, Dominik Heinzmann, Annabelle Monnet (2020). Integrating Phase 2 into Phase 3 based on an Intermediate Endpoint While Accounting for a Cure Proportion. Pharm. Stat., 19, 44-58.

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Ulrich Beyer, David Dejardin, Matthias Meller, Kaspar Rufibach, Hans Ulrich Burger (2020). A multistate model for early decision making in oncology. Biom. J., 62(3), 550-567.

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Matthias Meller, Jan Beyersmann, Kaspar Rufibach (2019). Joint modelling of progression-free and overall survival and computation of correlation measures. Stat. Med., 38, 4270-4289.

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Kaspar Rufibach (2019). Treatment Effect Quantification for Time-to-event Endpoints - Estimands, Analysis Strategies, and beyond. Pharm. Stat., 18, 144-164.

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Kaspar Rufibach, Hans Ulrich Burger, Markus Abt (2016). Bayesian Predictive Power: Choice of Prior and some Recommendations for its Use as Probability of Success in Drug Development. Pharm. Stat., 15, 438-446.

Link to journal R package Code on github

Elina Asikanius, Kaspar Rufibach, Jasmin Bahlo, Gabriele Bieska, Hans Ulrich Burger (2016). Comparison of design strategies for a three-arm clinical trial with time-to-event endpoint: power, time-to-analysis, and operational aspects. Biom. J., 58(6), 1295-1310.

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Kaspar Rufibach, Meng Chen, Hoa Nguyen (2016). Comparison of different clinical development plans for confirmatory subpopulation selection. Contemp. Clin. Trials, 47, 78-84.

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Kaspar Rufibach, Paul Jordan, Markus Abt (2016). Sequentially Updating the Likelihood of Success of a Phase 3 Pivotal Time-to-Event Trial based on Interim Analyses or External Information. J. Biopharm. Stat., 26(2), 191-201.

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Lutz Duembgen, Kaspar Rufibach, Dominic Schuhmacher (2014). Maximum-Likelihood Estimation of a Log-Concave Density based on Censored Data. Electron. J. Stat., 8, 1405-1437.

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Fadoua Balabdaoui, Hanna Jankowski, Kaspar Rufibach, Marios Pavlides (2013). Asymptotics of the discrete log-concave maximum likelihood estimator and related applications. J. R. Stat. Soc. Ser. B Stat. Methodol., 75(4), 769-790.

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Kaspar Rufibach (2012). A smooth ROC curve estimator based on log-concave density estimates. Int. J. Biostat., 8(1), 1-29.

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Kaspar Rufibach (2011). Selection models with monotone weight functions in meta analysis. Biom. J., 53(4), 689-704.

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Lutz Duemben, Kaspar Rufibach (2011). logcondens: Computations Related to Univariate Log-Concave Density Estimation. Journal of Statistical Software, 39(6), 1-28.

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Leonhard Held, Kaspar Rufibach, Fadoua Balabdaoui (2010). A score regression approach to assess calibration of probabilistic predictions. Biometrics, 66(4), 1295-1305.

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Fadoua Balabdaoui, Kaspar Rufibach, Filippo Santambrogio (2010). Least Squares estimation of two ordered monotone regression curves. J. Nonparametr. Stat., 22(8), 1019-1037.

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Kaspar Rufibach, Guenther Walther (2010). The block criterion for multiscale inference about a density, with applications to other multiscale problems. J. Comput. Graph. Statist., (19), 1, 175-190.

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Kaspar Rufibach (2010). An Active Set Algorithm to Estimate Parameters in Generalized Linear Models with Ordered Predictors. Comput. Statist. Data Anal., (54), pp. 1442-1456.

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Kaspar Rufibach (2009). reporttools: R Functions to Generate LaTeX Tables of Descriptive Statistics. Journal of Statistical Software, Code Snippets, (31), 1.

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Samuel Muller, Kaspar Rufibach (2009). Smooth tail index estimation. J. Statist. Comput. Simulation, (79), 1155-1167.

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Fadoua Balabdaoui, Kaspar Rufibach, Jon A Wellner (2009). Limit Distribution Theory for Maximum Likelihood Estimation of a Log-Concave Density. Ann. Statist., (37), 1299-1331.

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Lutz Duembgen, Kaspar Rufibach (2009). Maximum Likelihood Estimation of a Log-Concave Density and its Distribution Function. Bernoulli, (15), pp. 40–68.

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Samuel Muller, Kaspar Rufibach (2008). On the max-domain of attraction of distributions with log-concave densities. Statist. Probab. Lett., (78), 12, 1440-1444.

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Fadoua Balabdaoui, Kaspar Rufibach (2008). A second Marshall inequality in convex estimation. Statist. Probab. Lett., 78(2), 118-126.

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Kaspar Rufibach (2007). Computing Maximum Likelihood Estimators of a Log-Concave Density Function. J. Stat. Comput. Simul., 77(7), 561-574.

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Kaspar Rufibach, Manuel Bertschy, Manuela Schuettel, Michael Vock, Tina Wasserfallen (2001). Eintrittsraten und Austrittswahrscheinlichkeiten EVK 2000. Mitteilungen der Schweizerischen Aktuarvereinigung, 2001(1), 49-70.

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