Two-stage group-sequential designs with delayed responses – what is the point of applying corresponding methods?

Autor: Stephen Schüürhuis, Gernot Wassmer, Meinhard Kieser, Friedrich Pahlke, Cornelia Ursula Kunz, Carolin Herrmann

Publikováno v: BMC Medical Research Methodology, Vol 24, Iss 1, Pp 1-15 (2024)

Abstract Background In group-sequential designs, it is typically assumed that there is no time gap between patient enrollment and outcome measurement in clinical trials. However, in practice, there is usually a lag between the two time points. This c

Externí odkaz: https://doaj.org/article/6aef60e81a4b49ffa7cb6ae06dab44fa

Adaptive Designs

Autor: Gernot Wassmer, Franz Koenig, Martin Posch

Publikováno v: Handbook of Statistical Methods for Randomized Controlled Trials ISBN: 9781315119694

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::b3e5e930518161c8738ffa00b947cbf3
https://doi.org/10.1201/9781315119694-17

Efficient Adaptive Designs for Clinical Trials of Interventions for COVID-19

Autor: Peter K. Kimani, Martin Posch, Werner Brannath, Lisa V. Hampson, James Wason, Johannes Krisam, Thomas Jaki, S. Faye Williamson, Nigel Stallard, Sarah Zohar, Thomas Burnett, John Whitehead, Norbert Benda, Pavel Mozgunov, Franz Koenig, Gernot Wassmer, Tim Friede

Publikováno v: Statistics in Biopharmaceutical Research
Statistics in Biopharmaceutical Research, 2020, 12 (4), pp.483-497. ⟨10.1080/19466315.2020.1790415⟩
article-version (VoR) Version of Record

The COVID-19 pandemic has led to an unprecedented response in terms of clinical research activity. An important part of this research has been focused on randomized controlled clinical trials to evaluate potential therapies for COVID-19. The results

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::4d9e91dcef704c907a1dfc0389c3ff5a
https://hal.archives-ouvertes.fr/hal-03122983

Recent advances in methodology for clinical trials in small populations the InSPiRe project

Autor: Emmanuelle Comets, Martin Posch, Simon Day, A. Tournazi, Christian Röver, A. Dmitrenko, Burak Kürsad Günhan, Norbert Benda, Jason Madan, Corinne Alberti, Steffen Unkel, Nigel Stallard, Michael Pearce, Sarah Zohar, Frank Miller, Moreno Ursino, Frederike Lentz, Thomas Ondra, Tim Friede, Alexandra Graf, Gernot Wassmer, Siew Wan Hee

Publikováno v: Orphanet Journal of Rare Diseases
Orphanet Journal of Rare Diseases, 2018, 13 (1), pp.186. ⟨10.1186/s13023-018-0919-y⟩
Orphanet Journal of Rare Diseases, BioMed Central, 2018, 13 (1), pp.186. ⟨10.1186/s13023-018-0919-y⟩
Orphanet Journal of Rare Diseases, Vol 13, Iss 1, Pp 1-9 (2018)

Where there are a limited number of patients, such as in a rare disease, clinical trials in these small populations present several challenges, including statistical issues. This led to an EU FP7 call for proposals in 2013. One of the three projects

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::c8b74312613901ebe4824e310be45041
https://hal-univ-rennes1.archives-ouvertes.fr/hal-01935072/document

Twenty‐five years of confirmatory adaptive designs: opportunities and pitfalls

Autor: Gernot Wassmer, Frank Bretz, Franz König, Peter Bauer, Vladimir Dragalin

Publikováno v: Statistics in Medicine

‘Multistage testing with adaptive designs’ was the title of an article by Peter Bauer that appeared 1989 in the German journal Biometrie und Informatik in Medizin und Biologie. The journal does not exist anymore but the methodology found widespre

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::7e005d6ad70003b758b9d6badfb55515
https://doi.org/10.1002/sim.6472