Zobrazeno 1 - 10
of 44
pro vyhledávání: '"George Y. H. Chi"'
Publikováno v:
Contemporary Clinical Trials Communications, Vol 2, Iss C, Pp 34-53 (2016)
Contemporary Clinical Trials Communications
Contemporary Clinical Trials Communications
The basic problem that causes the frequent failure of a standard randomized parallel placebo-controlled clinical trial with a high placebo response rate is the underestimation of the treatment effect by the observed relative treatment difference. A t
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::7f74126228a369323717bf038118ef1a
Autor:
George Y. H. Chi
Publikováno v:
ICSA Book Series in Statistics ISBN: 9783319126937
In the design of noninferiority (NI) trials with binary outcomes, two basic problems are invariably present. The first problem pertains to the appropriateness of a fixed margin. The two-step fixed margin approach recommended in the Food and Drug Admi
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::041f7f433f68cac484262ec9ca704201
https://doi.org/10.1007/978-3-319-12694-4_13
https://doi.org/10.1007/978-3-319-12694-4_13
Publikováno v:
Journal of Biopharmaceutical Statistics. 16:151-164
There are essentially two kinds of non-inferiority hypotheses in an active control trial: fixed margin and ratio hypotheses. In a fixed margin hypothesis, the margin is a prespecified constant and the hypothesis is defined in terms of a single parame
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::6a286266622b6ba01f4973972b07cc71
https://doi.org/10.1080/10543400500508754
https://doi.org/10.1080/10543400500508754
Autor:
A. Lawrence Gould, George Y. H. Chi, Nancy L. Geller, Robert O'Neill, Surya Mohanty, Peter Bauer, Peter H. Westfall, David C. Jordan
Publikováno v:
Journal of Biopharmaceutical Statistics. 13:691-701
A Food and Drug Administration (FDA)/Industry/Academic Panel Discussion on multiplicity aspects of a real Phase III clinical trial was held at the Third International Conference on Multiple Comparisons, August 6, 2002, in Bethesda, Maryland. The goal
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::557c0f9a1f5a5bcbb332ed900bf300f3
https://doi.org/10.1081/bip-120024203
https://doi.org/10.1081/bip-120024203
Autor:
George Y. H. Chi
Publikováno v:
Drug Information Journal. 32:1347S-1362S
This paper gives a brief overview of some issues and some general concepts related to multiple testing problems as they are encountered in clinical drug trials. Some recent methods for handling mul...
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::7f8352752053deb935b2b3d4d2818ae3
https://doi.org/10.1177/00928615980320s131
https://doi.org/10.1177/00928615980320s131
Publikováno v:
Communications in Statistics - Theory and Methods. 23:341-360
It is becoming increasingly apparent that for reasons of safety, efficacy and cost, accurate and useful dose-response/dose-titration information should be provided by clinical trials and included in the drug product labeling. In this exposition, we d
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::bde065040f02855550a987cc5eb05b56
https://doi.org/10.1080/03610929408831259
https://doi.org/10.1080/03610929408831259
Publikováno v:
Communications in Statistics - Theory and Methods. 23:361-376
To be discussed are the practical considerations in the use of some statistical methods to evaluate clinical data for combination antihypertensive agents. The issues of interest concern efficacy and dose-response in a factorial clinical trial for mul
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::0d20b8245da7f2e7192ac613da3f41fc
https://doi.org/10.1080/03610929408831260
https://doi.org/10.1080/03610929408831260
Autor:
George Y. H. Chi, Qing Liu
Publikováno v:
Journal of biopharmaceutical statistics. 20(6)
The recent Food and Drug Administration (FDA) guidance for industry on adaptive designs is perhaps one of the important undertakings by CDER/CBER Office of Biostatistics. Undoubtedly, adaptive designs may affect almost all phases of clinical developm
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::eac3961c41b00723b496eb34111819f6
https://pubmed.ncbi.nlm.nih.gov/21058114
https://pubmed.ncbi.nlm.nih.gov/21058114
Publikováno v:
Encyclopedia of Biopharmaceutical Statistics ISBN: 1439822468
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::799609bf9562507003915e309a58503d
https://doi.org/10.3109/9781439822463.096
https://doi.org/10.3109/9781439822463.096