Zobrazeno 1 - 10
of 36
pro vyhledávání: '"Michael Branson"'
Publikováno v:
Statistics in Biopharmaceutical Research. 10:76-84
Making better use of evidence is one of the tenets of modern drug development. This calls for an understanding of the evidential strength of nonconfirmatory evidence relative to a confirmatory standard. Such inferential comparisons can be done via pr
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::a73cfeacc4b39bb14f040a5457afb194
https://doi.org/10.1080/19466315.2017.1392892
https://doi.org/10.1080/19466315.2017.1392892
Publikováno v:
Statistics and Probability Letters
Statistics and Probability Letters, Elsevier, 2011, 81 (7), pp.842. ⟨10.1016/j.spl.2011.02.010⟩
Statistics and Probability Letters, Elsevier, 2011, 81 (7), pp.842. ⟨10.1016/j.spl.2011.02.010⟩
International audience; A series of macros that have been created to perform fixed and random effects meta-analysis in SASare described as is the motivation for their creation. These macros are being made freely available on the internet for others t
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::2c70abb6799506427049d1efdeeaac26
https://doi.org/10.1016/j.spl.2011.02.010
https://doi.org/10.1016/j.spl.2011.02.010
Publikováno v:
Statistics in Medicine. 30:1618-1627
Traditional phase III non-inferiority trials require compelling evidence that the treatment vs control effect bfθ is better than a pre-specified non-inferiority margin θ(NI) . The standard approach compares this margin to the 95 per cent confidence
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::3b80a6476bebb74e882cce24422df39a
https://doi.org/10.1002/sim.3997
https://doi.org/10.1002/sim.3997
Publikováno v:
Clinical Trials. 8:129-143
Background In a pharmaceutical drug development setting, possible interactions between the treatment and particular baseline clinical or demographic factors are often of interest. However, the subgroup analysis required to investigate such associatio
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::47a1cb5cb69c756147bd407e73363220
https://doi.org/10.1177/1740774510396933
https://doi.org/10.1177/1740774510396933
Publikováno v:
Drug Information Journal. 44:299-315
Modern drug development requires an efficient clinical development program to have a reasonable chance of successfully leading to the submission of the therapy, given that the therapy is effective, or to early stopping if this is not the case. Clinic
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::53527a0d9a11bd57ac13c857997266fe
https://doi.org/10.1177/009286151004400312
https://doi.org/10.1177/009286151004400312
Autor:
Ji Zhang, Christy Chuang-Stein, Cyrus Hoseyni, Ray Bain, Michael Branson, Catherine Burton, Stephen J. Ruberg, Frank W. Rockhold
Publikováno v:
Statistics in Biopharmaceutical Research. 2:145-152
Pharmaceutical statisticians have come a long way during the past 50 years in supporting product discovery, development, manufacturing, and commercialization. Statisticians are either equal partners or are consultants in all areas of pharmaceutical r
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::30d887f835bfd1173584b1e1bb9b0d1c
https://doi.org/10.1198/sbr.2009.0036
https://doi.org/10.1198/sbr.2009.0036
Publikováno v:
Clinical Trials. 7:5-18
Background Historical information is always relevant when designing clinical trials, but it might also be incorporated in the analysis. It seems appropriate to exploit past information on comparable control groups. Purpose Phase IV and proof-of-conce
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::f9038706c4040737d7c965a7daebdb22
https://doi.org/10.1177/1740774509356002
https://doi.org/10.1177/1740774509356002
Autor:
Tony Tramontin, Pravin Chaturvedi, Ene I. Ette, John Orloff, Navjot Singh, Gigi Hirsch, Donald R. Stanski, Howard L. Golub, Frank L. Douglas, Cyrus R. Mehta, Edd Fleming, Sameer Sabir, Susan Levinson, José Pinheiro, Paul Gallo, Nitin R. Patel, Stacy L. Springs, Matthias Evers, Michael Branson
Publikováno v:
Nature Reviews Drug Discovery. 8:949-957
Declining pharmaceutical industry productivity is well recognized by drug developers, regulatory authorities and patient groups. A key part of the problem is that clinical studies are increasingly expensive, driven by the rising costs of conducting P
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::45a603d3049456a1aec435ff13234fa0
https://doi.org/10.1038/nrd3025
https://doi.org/10.1038/nrd3025
Publikováno v:
Statistics in Medicine. 28:3562-3566
The power prior by Ibrahim and Chen (Statist. Sci. 2000; 15:46–60) is one of several methods to incorporate historical data in the analysis of a clinical trial. The power prior raises the likelihood of the historical data to the power parameter a0
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::69b22c3967d7f8eae96ccf5ceb2d78f6
https://doi.org/10.1002/sim.3722
https://doi.org/10.1002/sim.3722
Autor:
Frank Bretz, Paul Gallo, Michael Branson, Martin Posch, Emmanuel Zuber, Amy Racine-Poon, Werner Brannath
Publikováno v:
Statistics in Medicine. 28:1445-1463
The ability to select a sensitive patient population may be crucial for the development of a targeted therapy. Identifying such a population with an acceptable level of confidence may lead to an inflation in development time and cost. We present an a
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::2d5ea961cdb7b17d41f459d3dbfa59bd
https://doi.org/10.1002/sim.3559
https://doi.org/10.1002/sim.3559