A novel approach to visualize clinical benefit of therapies for chronic graft versus host disease (cGvHD): the probability of being in response (PBR) applied to the REACH3 study.

Autor: Hollaender N; Novartis Pharma AG, Basel, Switzerland. norbert.hollaender@novartis.com., Glimm E; Novartis Pharma AG, Basel, Switzerland., Gauvin J; Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA., Stefanelli T; Novartis Pharma AG, Basel, Switzerland., Zeiser R; Department of Medicine I, Faculty of Medicine, Medical Centre, University of Freiburg, Freiburg, Germany.

Publikováno v: Bone marrow transplantation [Bone Marrow Transplant] 2024 Jan; Vol. 59 (1), pp. 12-16. Date of Electronic Publication: 2023 Oct 28.

Geometric approaches to assessing the numerical feasibility for conducting matching-adjusted indirect comparisons.

Autor: Glimm E; Novartis Pharma AG, Clinical Development and Analytics, Basel, Switzerland.; University of Magdeburg, Medical Faculty, Institute of Biometry and Medical Informatics, Magdeburg, Germany., Yau L; Novartis Pharma AG, Clinical Development and Analytics, Basel, Switzerland.

Publikováno v: Pharmaceutical statistics [Pharm Stat] 2022 Sep; Vol. 21 (5), pp. 974-987. Date of Electronic Publication: 2022 Mar 28.

Designing an exploratory phase 2b platform trial in NASH with correlated, co-primary binary endpoints.

Autor: Meyer EL; Center for Medical Data Science, Medical University of Vienna, Vienna, Austria., Mesenbrink P; Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, NJ, United States of America., Di Prospero NA; Janssen Research and Development, Raritan, NJ, United States of America., Pericàs JM; Liver Unit, Internal Medicine Department, Vall d'Hebron University Hospital, Vall d'Hebron Institute for Research (VHIR), Barcelona, Spain.; Centros de Investigación Biomédica en Red Enfermedades Hepáticas y Digestivas (CIBERehd), ISCIII, Madrid, Spain., Glimm E; Novartis Pharma AG, Basel, Switzerland.; Institute of Biometry and Medical Informatics, University of Magdeburg, Magdeburg, Germany., Ratziu V; Assistance Publique-Hôpitaux de Paris, Hôpital Pitie-Salpetriere, University of Paris, Paris, France., Sena E; Liver Unit, Internal Medicine Department, Vall d'Hebron University Hospital, Vall d'Hebron Institute for Research (VHIR), Barcelona, Spain., König F; Center for Medical Data Science, Medical University of Vienna, Vienna, Austria.

Publikováno v: PloS one [PLoS One] 2023 Mar 09; Vol. 18 (3), pp. e0281674. Date of Electronic Publication: 2023 Mar 09 (Print Publication: 2023).

On model-based time trend adjustments in platform trials with non-concurrent controls.

Autor: Bofill Roig M; Center for Medical Statistics, Informatics and Intelligent Systems, Medical University of Vienna, Vienna, Austria., Krotka P; Center for Medical Statistics, Informatics and Intelligent Systems, Medical University of Vienna, Vienna, Austria., Burman CF; Statistical Innovation, Data Science & Artificial Intelligence, AstraZeneca, Gothenburg, Sweden., Glimm E; Advanced Methodology and Data Science, Novartis Pharma AG, Basel, Switzerland.; Institute of Biometry and Medical Informatics, University of Magdeburg, Magdeburg, Germany., Gold SM; Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin, Berlin, Germany.; Medizinische Klinik m.S. Psychosomatik, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin, Berlin, Germany.; Institut für Neuroimmunologie und Multiple Sklerose (INIMS), Zentrum für Molekulare Neurobiologie, Universitätsklinikum Hamburg Eppendorf, Hamburg, Germany., Hees K; Section of Biostatistics, Paul-Ehrlich-Institut, Langen, Germany., Jacko P; Berry Consultants, Abingdon, UK.; Lancaster University, Lancaster, UK., Koenig F; Center for Medical Statistics, Informatics and Intelligent Systems, Medical University of Vienna, Vienna, Austria., Magirr D; Advanced Methodology and Data Science, Novartis Pharma AG, Basel, Switzerland., Mesenbrink P; Analytics Global Drug Development, Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA., Viele K; Berry Consultants, Austin, TX, USA., Posch M; Center for Medical Statistics, Informatics and Intelligent Systems, Medical University of Vienna, Vienna, Austria. martin.posch@meduniwien.ac.at.

Publikováno v: BMC medical research methodology [BMC Med Res Methodol] 2022 Aug 15; Vol. 22 (1), pp. 228. Date of Electronic Publication: 2022 Aug 15.

Connecting Instrumental Variable methods for causal inference to the Estimand Framework.

Autor: Bowden J; Exeter Diabetes Group (ExCEED), College of Medicine and Health, University of Exeter, Exeter, UK.; MRC Integrative Epidemiology Unit, University of Bristol, Bristol, UK., Bornkamp B; Novartis Pharma AG, Basel, Switzerland., Glimm E; Novartis Pharma AG, Basel, Switzerland.; Institute for Biometry and Medical Informatics, Medical Faculty, University of Magdeburg, Magdeburg, Germany., Bretz F; Novartis Pharma AG, Basel, Switzerland.; Section for Medical Statistics, Medical University of Vienna, Vienna, Austria.

Publikováno v: Statistics in medicine [Stat Med] 2021 Nov 10; Vol. 40 (25), pp. 5605-5627. Date of Electronic Publication: 2021 Jul 21.