Scientific Programme

Topic-contributed Sessions

A Critical Look at Propensity Score Methods - and Alternatives

Vanessa Didelez (Organizer), Stijn Vansteelandt (Organizer), Ingeborg Waernbaum (Speaker), Rhian Daniel (Speaker), Jamie Robins (Speaker)

Adaptive design and multiple testing procedures for small populations

Florian Klinglmueller (Organizer), Rene Schmidt (Organizer, Speaker), Katharina Hees (Speaker), Kornelius Rohmeyer (Speaker), James Wason (Speaker), Silke Jörgens (Speaker), Andreas Faldum (Chair)

Adaptive Enrichment Designs and Precision Medicine

Jie Chen (Organizer), Noah Simon (Invited speaker), Bo Yang (Speaker), Mark Chang (Speaker), Lindsay Renfro (Speaker)

Adaptive study designs for clinical trials and longitudinal data

Matthew S. Shotwell (Organizer, Speaker), Ben Saville (Speaker), Jonathan Schildcrout (Speaker), Weng Kee Wong (Speaker), Tom Parke (Chair)

Advanced Decision Making in Drug Development

Zoran Antonijevic (Organizer, Speaker), Martin Posch (Discussant), Robert A. Beckman (Speaker), Carl-Fredrik Burman (Speaker)

Advances in the model based dose finding

Valerii Fedorov (Organizer), Frank Bretz (Speaker), Moreno Ursino (Speaker), Fritjof Freise (Speaker)

Adverse event analyses: Is it time for new standards?

Claudia Schmoor (Organizer), Jan Beyersmann (Speaker), Florian Voß (Speaker), Andrew Thomson (Speaker), Tim Friede (Panelist), Ralf Bender (Panelist)

Applications of modern survival analysis methods

Lilla Di Scala (Speaker), Andreas Wienke (Speaker), Hein Putter (Speaker), Ekkehard Glimm (Speaker)

Basket trials using Bayesian adaptive design

Peter Mueller (Organizer, Discussant), Yuan Ji (Speaker), Yanxun XU (Speaker), Lorenzo TRIPPA (Speaker)

Big Data in practical applications

Malgorzata Bogdan (Organizer), Florian Frommlet (Speaker), Jaroslaw Harezlak (Speaker), Michal Kos (Speaker), Joanna Szyda (Speaker)

Biomarker Utilization in Innovative Clinical Designs

Mark Chang (Organizer), MingXiu Hu (Speaker), Yi Liu (Speaker), Jing Wang (Speaker), Robin Bliss (Speaker)

Biosimilar Drug Development: Statistical and Regulatory Issues

Byron Jones (Organizer), Johanna Mielke (Speaker), Thomas Lang (Speaker), Stephan Lehr (Speaker), Andrea Laslop (Discussant)

Challenges in planning time to event studies

Hans-Ulrich Burger (Organizer), Mike Branson (Organizer), Gareth Hughes (Speaker), Larry Leon (Speaker), Annabelle Monnet (Speaker)

Characterizing Clinical Dose Response Studies

Sandeep Menon (Organizer), Jose Pinheiro (Speaker), Dooti Roy (Speaker), Anidita Banerjee (Speaker), Simon Kirby (Discussant), Neil Thomas (Discussant)

Collaboration Space between Biostatistics and Pharmacometics: Opportunities and Challenges

José Pinheiro (Organizer), Michael Looby (Speaker), France Mentre (Speaker), Filip De Ridder (Speaker), Cyrus Hoseyni (Panelist), Efthymios Manolis (Panelist)

Complete, transparent and unbiased reporting as a requisite in research

Willi Sauerbrei (Organizer), Doug Altman (Speaker), Dirk Eyding (Panelist), Anne-Laure Boulesteix (Panelist), Peggy Sekula (Panelist)

Contributions for a better Teaching of Biometrical Topics

Geraldine Rauch (Organizer), N.N. (Discussant), Jessica Brensing (Speaker), Jochen Kruppa (Speaker), S. Englert (Speaker)

Data Monitoring Committees – Scope, Expectations and Challenges for DMC Clinicians and Statisticians

Amit Bhattacharyya (Organizer), Jonathan Seltzer (Panelist), Paul Gallo (Panelist), Adam Crisp (Panelist), Geert Molenberghs (Panelist), Lisa LaVange (Panelist), Frank Pétavy (Panelist)

Dealing with heterogeneity and multiplicity in small clinical trials

Susanne Urach (Organizer, Speaker), Robin Ristl (Speaker), Knut M. Wittkowsky (Speaker), Stavros Nikolakopoulos (Speaker), Andrea Smith (Speaker)

Decision Making in Early Clinical Development

Richardus Vonk (Organizer, Speaker), Thomas Jaki (Invited speaker), Andy Grieve (Speaker), Simon Kirby (Speaker)

Decision making in medical research

Gerhard Nehmiz (Organizer, Speaker), Stefan Klein (Speaker), Andreas Kaiser (Speaker), Jochem König (Speaker), Reinhard Vonthein (Chair)

Decision Theoretic Aproaches for Clinical Trial Design and Analysis

Martin Posch (Organizer), Franz König (Organizer), Yu Du (Speaker), Martin Forster (Speaker), Thomas Ondra (Speaker), Jason Madon (Speaker)

Design and Analysis of Multi-Regional Clinical Trials

Jie Chen (Organizer, Discussant), Ming Tan (Speaker), Bill Wang (Speaker), Hsiao-Hui Tsou (Speaker)

Design of Experiments in Mixed Models

Maryna Prus (Organizer, Speaker), Florence Loingeville (Speaker), Joachim Kunert (Speaker), Augustyn Markiewicz (Speaker), Heinz Holling (Speaker)

Development and Validation of Bioanalytical Methods

Jie Chen (Organizer, Discussant), Harry Yang (Speaker), Tsai-Lien Lin (Speaker), Yi Tsong (Speaker)

Emerging Topics in the Design and Analysis of Clinical Trials

Jie Chen (Organizer), Yuan-Chin Ivan Chang (Speaker), Mei Cheng (Speaker), Hisashi Noma (Speaker), Armin Schueler (Speaker)

Evidence synthesis and meta-analysis

Tim Friede (Organizer), Heinz Schmidli (Invited speaker), Christian Röver (Speaker), Leonhard Held (Speaker)

Evidence Synthesis: Statistics meets Formal Epistemology

Barbara Osimani (Organizer), Ulrich Mannsmann (Panelist), Ralph Edwards (Panelist), Jürgen Landes (Panelist), Jan Sprenger (Panelist), Roland Poellinger (Panelist)

Experimental Design I (Theory and Application)

Karl Moder (Organizer), Jürgen Pilz (Speaker), Werner Müller (Speaker), Malgorzata Graczyk (Speaker), Bernhard Spangl (Speaker), Vaclav Adamec (Speaker)

Experimental Design II (related to agricultural experiments)

Karl Moder (Organizer, Speaker), Hans-Peter Piepho (Speaker), Iwona Mejza (Speaker), Jens Möhring (Speaker), Paul Schmidt (Speaker)

Futility evaluation in complex clinical trials

Koko Asakura (Organizer, Speaker), Frank Bretz (Organizer), Tim Friede (Speaker), Paul Gallo (Speaker), Susan Halabi (Speaker)

High-dimensional data and 'omics (but not exclusively)

Florian Frommlet (Organizer), Malgorzata Bogdan (Speaker), Mélina Gallopin (Speaker), Gregory Nuel (Speaker), Aliaksandr Hubin (Speaker)

Historical data for confirmatory prospective clinical trials – a contradiction?

Franz König (Organizer), Stephen Senn (Speaker), Simon Wandel (Speaker), Dominic Magirr (Speaker), David Dejardin (Speaker), David J Wright (Discussant)

Identification and reliable treatment effect estimation

Bjoern Bornkamp (Organizer), Julian Riehl (Speaker), Nicolas Ballarini (Speaker), Marius Thomas (Speaker)

Industry Leadership Panel Discussion

Amit Bhattacharyya (Organizer), Frank Bretz (Organizer), Lisa LaVange (Panelist), Bob Rodriguez (Panelist), Sara Hughes (Panelist), Nevine Zariffa (Panelist), Pandu Kulkarni (Panelist), Jerry Schindler (Panelist), Eric Gibson (Panelist), Ivan S.F. Chan (Panelist)

Innovative Applications of Resampling in Complex Models

Arne Bathke (Organizer), Markus Pauly (Organizer), Sarah Friedrich (Speaker), Maria Umlauft (Speaker), Judith Parkinson (Speaker), Georg Zimmermann (Speaker)

Innovative Trial Designs in Pharmaceutical Development

Ivan S.F. Chan (Organizer), J. Jack Lee (Invited speaker), Ming-Hui Chen (Speaker), Cyrus Mehta (Speaker), Keaven Anderson (Speaker)

Is there a place for single-arm studies in clinical research?

Hans-Ulrich Burger (Organizer), Marcel Wolbers (Organizer), Franz König (Speaker), Michael J. Grayling (Speaker), David Wright (Discussant)

Joint modeling and joint inference for multiple outcomes

Robin Ristl (Organizer), Geert Molenberghs (Speaker), Ludwig Hothorn (Speaker), Daniel Gerhard (Speaker), Christian Ritz (Speaker), Dimitris Rizopoulos (Discussant)

Methodological challenges in observational studies: promoting best practice and relevant research (2 Sessions)

Willi Sauerbrei (Organizer, Speaker), Doug Altman (Speaker), Matthias Schmid (Speaker), Peggy Sekula (Speaker), Jörg Rahnenführer (Speaker), Pamela Shaw (Speaker)

New Developments in Adaptive Dose-Ranging Studies

Vladimir Dragalin (Organizer), Tobias Mielke (Speaker), Yevgan Tymofyeyev (Speaker), Bjoern Bornkamp (Speaker), Natalja Strelkowa (Speaker), Alun Bedding (Discussant)

New Innovations in Handling Longitudinal Biomedical Data using Bayesian Methods

Arkendu Chatterjee (Organizer), Michael J. Daniels (Speaker), Debajyoti Sinha (Speaker), Jason A. Roy (Speaker), Dimitris Rizopoulos (Speaker)

Non-Parametric Tests in Non-Standard Situations

Martin Posch (Organizer), Michael Proschan (Invited speaker), Meinhard Kieser (Speaker), Matthias Brückner (Speaker), Arne Bathke (Speaker)

Quantum computing in statistics and machine learning

Valerii Fedorov (Organizer, Speaker), Peter Wittek (Speaker), Anatoly Zhigljavsky (Speaker), Frank Bretz (Chair), Alexander Gammerman (Discussant)

Rank-based biomedical computing and applications

Michael G. Schimek (Organizer), Joseph Verducci (Speaker), Manuela Zucknick (Speaker), Vendula Svendova (Speaker)

Ranks and Preudo-Ranks: - Nonparametric Effect Measures in Biomedical Research

Edgar Brunner (Organizer, Speaker), Xin Gao (Speaker), Martin Happ (Speaker), Arne Bathke (Chair)

Recent approaches to foster statistical innovation in the pharmaceutical industry

Christoph Muysers (Organizer, Speaker), Hans-Juergen Lomp (Speaker), David J Wright (Speaker), Hermann Kulmann (Speaker)

Recent Development in Design and Analysis of Dose Finding Trials

Jie Chen (Organizer), Larry Gould (Speaker), Ying Lu (Speaker), Ying Yuan (Speaker), Naitee Ting (Speaker)

Reproducible research - can we really separate the wheat from the chaff?

Franz Koenig (Organizer), Martin Posch (Organizer), Doug Altman (Panelist), Peter Bauer (Panelist), Yoav Benjamini (Panelist), John P.A. Ioannidis (Panelist), Regina Nuzzo (Panelist), Stephen Senn (Panelist)

Safety Evaluation, Data Sources and Statistical Strategies: Transforming Data into Evidence

William Wang (Organizer, Speaker), Olga Marchenko (Speaker), Jie Chen (Panelist), Franz König (Panelist), Jürgen Kübler (Panelist), Michael O'Kelly (Chair)

Scared of rare events? Small-sample bias, unmeasured confounding and other dangerous things

Georg Heinze (Organizer), Lara Lusa (Organizer), Ioannis Kosmidis (Invited speaker), Michal Abrahamowicz (Speaker), Rok Blagus (Speaker), Jelle Goeman (Speaker)

Signal detection in spontaneous reports with focus on increased frequency signals

Conny Berlin (Organizer), William DuMouchel (Speaker), Jürgen Kübler (Speaker), Gianmario Candore (Speaker), Günter Heimann (Speaker)

Statistical Approaches for Model-Based Clinical Trial Designs

Peter Mueller (Organizer, Speaker (see comment)), Yuan Ji (Organizer), Beat Neuenschwander (Speaker), Satoshi Morita (Speaker), Yisheng Li (Speaker), Sue-Jane Wang (Speaker)

Statistical Challenges in the Development of Biosimilars

Dominik Heinzmann (Organizer, Speaker), Dejun Tang (Organizer, Speaker), Shanmei Liao (Speaker), Andreas Brandt (Speaker)

Statistical Challenges Surrounding Multi-Regional Clinical Trials and Global Medical Product Development

Toshimitsu Hamasaki (Organizer), Chinfu Hsiao (Organizer, Speaker), Yuki Ando (Speaker), Gang Chen (Speaker), Luyan Dai (Speaker)

Statistical design of clinical studies and modelling of related operational processes

Valerii Fedorov (Organizer), Zoran Antonijevic (Organizer), Vladimir Anisimov (Speaker), Nitin Patel (Speaker), Suresh Ankolekar (Speaker), Matthew Austin (Speaker)

Statistical Innovation Panel Discussion

Frank Bretz (Organizer), Byron Jones (Chair), Nicky Best (Panelist), Hans-Ulrich Burger (Panelist), Andy Grieve (Panelist), Joseph Heyse (Panelist), Hermann Kulmann (Panelist), Sandeep Menon (Panelist), Walt Offen (Panelist), Jose Pinheiro (Panelist), Stephen Ruberg (Panelist), David J Wright (Panelist)

Statistical issues in umbrella trials

Hong Sun (Organizer), Marc Buyse (Speaker), Werner Vach (Speaker), Lucinda Billingham (Speaker)

Statistical Methodology for the Design and Analysis of Trials in Small Populations

Martin Posch (Organizer), Robert Beckman (Organizer), Ralf-Dieter Hilgers (Speaker), Kit Roes (Speaker), Nigel Stallard (Speaker), Ralf Herold (Discussant)

Statistical methods for cardiovascular outcome studies

Antje Jahn (Organizer), Jennifer Rogers (Invited speaker), Mouna Akacha (Speaker), Gerrit Toenges (Speaker), Geraldine Rauch (Speaker), Francesca Ieva (Speaker)

Statistical Methods in Outcome research

Irene Schmidtmann (Organizer), Oliver Kuß (Speaker), Christian Stock (Speaker), Harald Binder (Speaker)

Statistical Strategies and Methods in Vaccine Development

Fabian Tibaldi (Organizer), An Vandebosch (Organizer, Speaker), Alexander R Luedtke (Speaker), Andrea Callegaro (Speaker), Jose Pinheiro (Chair)

Subgroup analyses in clinical trials and systematic reviews

Arne Ring (Organizer, Speaker), Aaron Dane (Speaker), Armin Koch (Discussant), Ralf Bender (Speaker), Simon Day (Discussant), Friedhelm Leverkus (Chair), Gerd Rosenkranz (Chair)

The assessment of probability of success for clinical trials

Hans-Ulrich Burger (Organizer), Kaspar Rufibach (Organizer, Speaker), Nigel Dallow (Speaker), Heiko Götte (Speaker), Ben Saville (Discussant), Marcel Wolbers (Organizer)

The future world of clinical research: Are we ready for big data

Dominik Heinzmann (Organizer), Hans-Ulrich Burger (Organizer, Speaker), Athula Herath (Speaker), Tim Friede (Discussant)

The use of Matching Adjusted Indirect Comparison in Health Technology Assessments (HTA)

Mark Belger (Organizer), David Phillippo (Speaker), Helmut Petto (Speaker), Daniel Saure (Speaker)

Trending Topics in Health Economics and Outcomes Research

Demissie Alemayehu (Organizer), Sebastian Schneeweiss (Speaker), Christopher Schmid (Speaker), Richard J. Willke (Speaker), Martijn Schuemie (Speaker)

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