Zobrazeno 1 - 10
of 138
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:
Tim Friede, Martin Posch, Sarah Zohar, Corinne Alberti, Norbert Benda, Emmanuelle Comets, Simon Day, Alex Dmitrienko, Alexandra Graf, Burak Kürsad Günhan, Siew Wan Hee, Frederike Lentz, Jason Madan, Frank Miller, Thomas Ondra, Michael Pearce, Christian Röver, Artemis Toumazi, Steffen Unkel, Moreno Ursino, Gernot Wassmer, Nigel Stallard
Publikováno v:
Orphanet Journal of Rare Diseases, Vol 13, Iss 1, Pp 1-9 (2018)
Abstract 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
Externí odkaz:
https://doaj.org/article/9b388cef7daa4326aa630be227e4381e
Autor:
Michael Pearce, Siew Wan Hee, Jason Madan, Martin Posch, Simon Day, Frank Miller, Sarah Zohar, Nigel Stallard
Publikováno v:
BMC Medical Research Methodology, Vol 18, Iss 1, Pp 1-9 (2018)
Abstract 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 th
Externí odkaz:
https://doaj.org/article/2b63edc215164179a716c48fee8c16e5
Autor:
Robin Michelet, Moreno Ursino, Sandrine Boulet, Sebastian Franck, Fiordiligie Casilag, Mara Baldry, Jens Rolff, Madelé van Dyk, Sebastian G. Wicha, Jean-Claude Sirard, Emmanuelle Comets, Sarah Zohar, Charlotte Kloft
Publikováno v:
Pharmaceutics, Vol 13, Iss 5, p 601 (2021)
The treatment of respiratory tract infections is threatened by the emergence of bacterial resistance. Immunomodulatory drugs, which enhance airway innate immune defenses, may improve therapeutic outcome. In this concept paper, we aim to highlight the
Externí odkaz:
https://doaj.org/article/1106c0729a17429d82e8734a1fc48bbb
Autor:
Florentia Kaguelidou, Corinne Alberti, Valerie Biran, Olivier Bourdon, Caroline Farnoux, Sarah Zohar, Evelyne Jacqz-Aigrain
Publikováno v:
PLoS ONE, Vol 11, Iss 12, p e0166207 (2016)
Proton pump inhibitors are frequently administered on clinical symptoms in neonates but benefit remains controversial. Clinical trials validating omeprazole dosage in neonates are limited. The objective of this trial was to determine the minimum effe
Externí odkaz:
https://doaj.org/article/b99e8904b84542fbad924bf99a2282f3
Autor:
Elisabeth Chéreau, Catherine Uzan, Emmanuelle Boutmy-Deslandes, Sarah Zohar, Corinne Bézu, Chafika Mazouni, Jean-Rémi Garbay, Emile Daraï, Roman Rouzier
Publikováno v:
PLoS ONE, Vol 11, Iss 6, p e0156096 (2016)
OBJECTIVE:The aim of this study was to assess the efficacy (response rate centered on 80%) of a somatostatin analog with high affinity for 4 somatostatin receptors in reducing the postoperative incidence of symptomatic lymphocele formation following
Externí odkaz:
https://doaj.org/article/5c198a1168ff414f82fabe7e531dbc86
Autor:
Silvia Calderazzo, Sergey Tarima, Carissa Reid, Nancy Flournoy, Tim Friede, Nancy Geller, James L Rosenberger, Nigel Stallard, Moreno Ursino, Marc Vandemeulebroecke, Kelly Van Lancker, Sarah Zohar
Publikováno v:
Statistics in Biopharmaceutical Research. :1-33
Clinical trials disruption has always represented a non negligible part of the ending of interventional studies. While the SARS-CoV-2 (COVID-19) pandemic has led to an impressive and unprecedented initiation of clinical research, it has also led to c
Publikováno v:
Statistical Methods in Medical Research
Statistical Methods in Medical Research, 2023, 32 (5), pp.963-977. ⟨10.1177/09622802231160554⟩
Statistical Methods in Medical Research, 2023, 32 (5), pp.963-977. ⟨10.1177/09622802231160554⟩
Master protocol designs allow for simultaneous comparison of multiple treatments or disease subgroups. Master protocols can also be designed as seamless studies, in which two or more clinical phases are considered within the same trial. They can be d
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0b8891b8702f7d1ceb02e856d302f6bf
https://hal.science/hal-04126394
https://hal.science/hal-04126394
Publikováno v:
Statistics in Medicine
Statistics in Medicine, 2022, 41 (20), pp.3915-3940. ⟨10.1002/sim.9484⟩
Statistics in Medicine, 2022, 41 (20), pp.3915-3940. ⟨10.1002/sim.9484⟩
Phase I early-phase clinical studies aim at investigating the safety and the underlying dose-toxicity relationship of a drug or combination. While little may still be known about the compound's properties, it is crucial to consider quantitative infor
Autor:
John O'Quigley, Sarah Zohar, David M. Hyman, John F. Gerecitano, David R. Spriggs, Mrinal Gounder, Alexia Iasonos
The rate of observed dose-limiting toxicities (DLT) determines the maximum tolerated dose (MTD) in phase I trials. There are cases in which non–drug-related toxicities or other-cause toxicities (OCT) are flagged as DLTs, or vice versa, due to attri
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::24ee84941e56ad45f0facd6d85c8bc37
https://doi.org/10.1158/1078-0432.c.6523119.v1
https://doi.org/10.1158/1078-0432.c.6523119.v1