Zobrazeno 1 - 10
of 55
pro vyhledávání: '"Brian L. Wiens"'
Autor:
Brian L. Wiens, Ilya Lipkovich
Publikováno v:
Statistics in Biopharmaceutical Research
article-version (VoR) Version of Record
article-version (VoR) Version of Record
–The COVID-19 pandemic has impacted ongoing clinical trials. We consider particular impacts on noninferiority clinical trials, which aim to show that an investigational treatment is not markedly worse than an existing active control with known bene
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::fe3debecab6938662ac4911f903e8038
https://doi.org/10.1080/19466315.2020.1788983
https://doi.org/10.1080/19466315.2020.1788983
Autor:
Brian L. Wiens
Publikováno v:
Handbook of Statistical Methods for Randomized Controlled Trials ISBN: 9781315119694
Handbook of Statistical Methods for Randomized Controlled Trials
Handbook of Statistical Methods for Randomized Controlled Trials
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::7f5c4bec8f277fac335fa680168c4435
https://doi.org/10.1201/9781315119694-24
https://doi.org/10.1201/9781315119694-24
Autor:
Ilya Lipkovich, Brian L. Wiens
Publikováno v:
Statistics in Biopharmaceutical Research. 10:57-69
We consider the role of multiple imputation (MI) when analyzing noninferiority (NI) clinical trials with missing data. When the endpoint is measured longitudinally, direct-likelihood methods can be used. In this article, the focus is on the situation
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::238aae7cf92c6d8f02b8e83200351ee2
https://doi.org/10.1080/19466315.2017.1379433
https://doi.org/10.1080/19466315.2017.1379433
Autor:
Brian L. Wiens, Florie A. Mar, Janice Castillo, Janet M. Leeds, Pamela B. Conley, John T. Curnutte, Mark Crowther, Stuart J. Connolly, Alex Gold, Michele D. Bronson, Deborah M. Siegal, Vandana Mathur, Genmin Lu, Abstr Act
Publikováno v:
New England Journal of Medicine. 373:2413-2424
Bleeding is a complication of treatment with factor Xa inhibitors, but there are no specific agents for the reversal of the effects of these drugs. Andexanet is designed to reverse the anticoagulant effects of factor Xa inhibitors.Healthy older volun
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::68318b7119cabb75a0ac09744d25129e
https://doi.org/10.1056/nejmoa1510991
https://doi.org/10.1056/nejmoa1510991
Autor:
Brian L. Wiens, Jeffrey Vest, Guruprasad P. Aithal, Arun J. Sanyal, Star Seyedkazemi, Vincent Wai-Sun Wong, Zachary Goodman, Laurent Fischer, Rohit Loomba, Eric Lefebvre, Vlad Ratziu, Frank Tacke, Kris V. Kowdley, Geoffrey C. Farrell, Manal F. Abdelmalek, Pamela Vig, Liza Melchor-Khan, Antonio Craxì, Scott L. Friedman, Krzysztof Simon, Juan Caballería, Stephen A. Harrison, Sven Francque
Publikováno v:
Hepatology (Baltimore, Md.), vol 67, iss 5
Hepatology
Hepatology (Baltimore, Md.)
Hepatology
Hepatology (Baltimore, Md.)
The aim of this study was to evaluate cenicriviroc (CVC), a dual antagonist of C-C chemokine receptor types 2 and 5, for treatment of nonalcoholic steatohepatitis (NASH) with liver fibrosis. A randomized, double-blind, multinational phase 2b study en
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::dd279267e63b246d0eb39c5941a3a85b
https://nottingham-repository.worktribe.com/file/927093/1/Friedman_et_al-2018-Hepatology.pdf
https://nottingham-repository.worktribe.com/file/927093/1/Friedman_et_al-2018-Hepatology.pdf
Autor:
Brian L. Wiens
Publikováno v:
Journal of biopharmaceutical statistics. 28(1)
We consider analysis of active control, non-inferiority clinical trials with multiple primary endpoints for assessing efficacy of an investigational treatment. Many of the issues with multiple endpoints for non-inferiority trials are similar to issue
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::75b47343377aef2dbc3e59eac3500455
https://pubmed.ncbi.nlm.nih.gov/29065276
https://pubmed.ncbi.nlm.nih.gov/29065276
Publikováno v:
Therapeutic Innovation & Regulatory Science. 48:90-97
Clinical trials in the development of new medical device products are in many ways analogous to clinical trials in the development of new drug or biologic products. However, the differences are important and not always intuitive to a statistician wit
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9cec35e52333dce8130f791991204b1a
https://doi.org/10.1177/2168479013507272
https://doi.org/10.1177/2168479013507272
Autor:
Gerd K. Rosenkranz, Brian L. Wiens
Publikováno v:
Statistics in Biopharmaceutical Research. 5:383-393
Missing data in clinical trials has been widely discussed in the literature, but issues specific to missing data in noninferiority trials have rarely been addressed. The goal of this article is to present missing data issues that are particularly imp
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::9a5f289e4ae3d5ab63b3a5928847fd1a
https://doi.org/10.1080/19466315.2013.847383
https://doi.org/10.1080/19466315.2013.847383
Publikováno v:
Journal of Biopharmaceutical Statistics. 23:1403-1419
This article discusses the problem of selecting free parameters of multiple testing procedures in confirmatory Phase III clinical trials with multiple objectives, including hypothesis weights and hypothesis ordering. We identify classes of multiple t
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::249839e8af16285e7fc753fb11417a85
https://doi.org/10.1080/10543406.2013.834920
https://doi.org/10.1080/10543406.2013.834920
Publikováno v:
Design and Analysis of Non-Inferiority Trials ISBN: 9780429138591
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::cbd5633a878374f859925905fb35378b
https://doi.org/10.1201/b11039-7
https://doi.org/10.1201/b11039-7