Zobrazeno 1 - 10
of 41
pro vyhledávání: '"Sarah Zohar"'
Publikováno v:
BMC Medical Research Methodology, Vol 19, Iss 1, Pp 1-13 (2019)
Abstract Background When conducing Phase-III trial, regulatory agencies and investigators might want to get reliable information about rare but serious safety outcomes during the trial. Bayesian non-inferiority approaches have been developed, but com
Externí odkaz:
https://doaj.org/article/e39b28412a34444097f33868ced5f9a3
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
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
https://hal.archives-ouvertes.fr/hal-03122983
Publikováno v:
Statistics in Biopharmaceutical Research
Statistics in Biopharmaceutical Research, 2020, 12 (4), pp.478-482. ⟨10.1080/19466315.2020.1800509⟩
article-version (VoR) Version of Record
Statistics in Biopharmaceutical Research, 2020, 12 (4), pp.478-482. ⟨10.1080/19466315.2020.1800509⟩
article-version (VoR) Version of Record
The Cape-Covid trial is an embedded clinical trial within the ongoing Cape-Cod trial. The Covid-19 pandemic appeared while we were conducting a randomized trial assessing the effectiveness of corticosteroids in severe community-acquired pneumonia. We
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e4238422e9ca25e296faaca1f7017397
https://hal.archives-ouvertes.fr/hal-03122980
https://hal.archives-ouvertes.fr/hal-03122980
Autor:
Kelly Van Lancker, Silke Jörgens, Christoph Gerlinger, Frank Bretz, Dong Xi, Tim Friede, Nigel Stallard, Sarah Zohar, Cornelia Ursula Kunz
Publikováno v:
Statistics in Biopharmaceutical Research
Statistics in Biopharmaceutical Research, 2020, 12 (4), pp.461-477. ⟨10.1080/19466315.2020.1799857⟩
article-version (VoR) Version of Record
Statistics in Biopharmaceutical Research, 2020, 12 (4), pp.461-477. ⟨10.1080/19466315.2020.1799857⟩
article-version (VoR) Version of Record
Very recently the new pathogen severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was identified and the coronavirus disease 2019 (COVID-19) declared a pandemic by the World Health Organization. The pandemic has a number of consequences for
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::2fc769820c29a051f489fcbf65bc34b7
Publikováno v:
BMC Medical Research Methodology
BMC Medical Research Methodology, BioMed Central, 2019, 19 (1), pp.187. ⟨10.1186/s12874-019-0826-5⟩
BMC Medical Research Methodology, 2019, 19 (1), pp.187. ⟨10.1186/s12874-019-0826-5⟩
BMC Medical Research Methodology, Vol. 19, No 1 (2019) P. 187
BMC Medical Research Methodology, Vol 19, Iss 1, Pp 1-13 (2019)
BMC Medical Research Methodology, BioMed Central, 2019, 19 (1), pp.187. ⟨10.1186/s12874-019-0826-5⟩
BMC Medical Research Methodology, 2019, 19 (1), pp.187. ⟨10.1186/s12874-019-0826-5⟩
BMC Medical Research Methodology, Vol. 19, No 1 (2019) P. 187
BMC Medical Research Methodology, Vol 19, Iss 1, Pp 1-13 (2019)
BackgroundWhen conducing Phase-III trial, regulatory agencies and investigators might want to get reliable information about rare but serious safety outcomes during the trial. Bayesian non-inferiority approaches have been developed, but commonly util
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::93fed5f5c3e0d87fd3adb84555bf6937
https://www.hal.inserm.fr/inserm-02456619
https://www.hal.inserm.fr/inserm-02456619
Autor:
Mårten Vågerö, Martin Posch, Frank Miller, Siew Wan Hee, Jason Madan, Michael Pearce, Simon Day, Nigel Stallard, Sarah Zohar
Publikováno v:
Pharmaceutical Statistics. 17:214-230
We discuss 3 alternative approaches to sample size calculation: traditional sample size calculation based on power to show a statistically significant effect, sample size calculation based on assurance, and sample size based on a decision-theoretic a
The Simon's two-stage design is the most commonly applied among multi-stage designs in phase IIA clinical trials. It combines the sample sizes at the two stages in order to minimize either the expected or the maximum sample size. When the uncertainty
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a89ebc7e04a624f590f0fa99b2251d59
http://hdl.handle.net/11577/3283095
http://hdl.handle.net/11577/3283095
Autor:
Emmanuelle Comets, Corinne Alberti, Tim Friede, Artemis Toumazi, Moreno Ursino, Frederike Lentz, Nigel Stallard, Sarah Zohar
Publikováno v:
Computer Methods and Programs in Biomedicine
Computer Methods and Programs in Biomedicine, Elsevier, 2018, 157, pp.163-177. ⟨10.1016/j.cmpb.2018.01.023⟩
Computer Methods and Programs in Biomedicine, 2018, 157, pp.163-177. ⟨10.1016/j.cmpb.2018.01.023⟩
Computer Methods and Programs in Biomedicine, Elsevier, 2018, 157, pp.163-177. ⟨10.1016/j.cmpb.2018.01.023⟩
Computer Methods and Programs in Biomedicine, 2018, 157, pp.163-177. ⟨10.1016/j.cmpb.2018.01.023⟩
International audience; Background and objective - Dose-finding, aiming at finding the maximum tolerated dose, and pharmacokinetics studies are the first in human studies in the development process of a new pharmacological treatment. In the literatur
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::348731ed931352b7bf52edab9afdd63f
https://hal-univ-rennes1.archives-ouvertes.fr/hal-01737106/document
https://hal-univ-rennes1.archives-ouvertes.fr/hal-01737106/document
Autor:
Martin Posch, Frank Miller, Nigel Stallard, Sarah Zohar, Jason Madan, Simon Day, Michael Pearce, Siew Wan Hee
Publikováno v:
BMC Medical Research Methodology
BMC Medical Research Methodology, BioMed Central, 2018, 18 (1), pp.20. ⟨10.1186/s12874-018-0475-0⟩
BMC Medical Research Methodology, Vol 18, Iss 1, Pp 1-9 (2018)
BMC Medical Research Methodology, 2018, 18 (1), pp.20. ⟨10.1186/s12874-018-0475-0⟩
BMC Medical Research Methodology, BioMed Central, 2018, 18 (1), pp.20. ⟨10.1186/s12874-018-0475-0⟩
BMC Medical Research Methodology, Vol 18, Iss 1, Pp 1-9 (2018)
BMC Medical Research Methodology, 2018, 18 (1), pp.20. ⟨10.1186/s12874-018-0475-0⟩
Background Most confirmatory randomised controlled clinical trials (RCTs) are designed with specified power, usually 80% or 90%, for a hypothesis test conducted at a given significance level, usually 2.5% for a one-sided test. Approval of the experim
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::36145dfd74d83387ac0ce595dcfc5367
http://wrap.warwick.ac.uk/99080/1/WRAP-value-iinformation-methods-design-Stallard-2018.pdf
http://wrap.warwick.ac.uk/99080/1/WRAP-value-iinformation-methods-design-Stallard-2018.pdf
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)
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
https://hal-univ-rennes1.archives-ouvertes.fr/hal-01935072/document