Zobrazeno 1 - 10
of 26
pro vyhledávání: '"Margaret Gamalo‐Siebers"'
Autor:
Yodit Seifu, Shahrul Mt-Isa, Kyle Duke, Margaret Gamalo-Siebers, William Wang, Gaohong Dong, John Kolassa
Publikováno v:
Journal of Biopharmaceutical Statistics. :1-12
A fundamental problem in the regulatory evaluation of a therapy is assessing whether the benefit outweighs the associated risks. This work proposes designing a trial that assesses a composite endpoint consisting of benefit and risk, hence, making the
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::4faf399c10b9d36eaf936b92bc22a3c3
https://doi.org/10.1080/10543406.2022.2153202
https://doi.org/10.1080/10543406.2022.2153202
Autor:
James Song, Johan Verbeeck, Bo Huang, David C. Hoaglin, Margaret Gamalo-Siebers, Yodit Seifu, Duolao Wang, Freda Cooner, Gaohong Dong
Publikováno v:
Journal of Biopharmaceutical Statistics. 33:140-150
Generalized pairwise comparisons and win statistics (i.e., win ratio, win odds and net benefit) are advantageous in analyzing and interpreting a composite of multiple outcomes in clinical trials. An important limitation of these statistics is their i
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a9b959881e966e7679f0b2e5bb9e6641
https://doi.org/10.1080/10543406.2022.2089156
https://doi.org/10.1080/10543406.2022.2089156
Autor:
Gaohong Dong, David C. Hoaglin, Bo Huang, Ying Cui, Duolao Wang, Yu Cheng, Margaret Gamalo‐Siebers
Publikováno v:
Pharmaceutical Statistics.
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::56b01b979b54057cad27150b31c78622
https://doi.org/10.1002/pst.2293
https://doi.org/10.1002/pst.2293
Autor:
Bernard Sebastien, S. Y. Amy Cheung, Solange Corriol-Rohou, Margaret Gamalo-Siebers, Rana Jreich, Rajesh Krishna, Jing Liu
Publikováno v:
Journal of biopharmaceutical statistics.
The use of Bayesian methodology to design and analyze pediatric efficacy trials is one of the possible options to reduce their sample size. This reduction of the sample size results from the use of an informative prior for the parameters of interest.
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::597ccf6ce99a8ebe471c628c10caf731
https://pubmed.ncbi.nlm.nih.gov/36524777
https://pubmed.ncbi.nlm.nih.gov/36524777
Publikováno v:
Pharmaceutical Statistics. 21:327-344
In many orphan diseases and pediatric indications, the randomized controlled trials may be infeasible because of their size, duration, and cost. Leveraging information on the control through a prior can potentially reduce sample size. However, unless
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::7bafb8eae25fd88b709d05bf0e6370be
https://doi.org/10.1002/pst.2172
https://doi.org/10.1002/pst.2172
Publikováno v:
Journal of biopharmaceutical statistics.
For the clinical studies in rare diseases or small patient populations, having an adequately powered randomized controlled trial is further complicated by variability. As such, sample size re-estimation can be a useful tool if at an interim look the
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::086a32194ee30c04d15db2b5fff05c71
https://pubmed.ncbi.nlm.nih.gov/35730907
https://pubmed.ncbi.nlm.nih.gov/35730907
Publikováno v:
Journal of Biopharmaceutical Statistics. 31:113-116
The special issue on innovative design and analysis of complex clinical trials (Volume 30, Issue 6) is a compilation of invited papers from speakers at the April 2019 Duke-Industry Statistics Sympo...
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::5ae7517bb6740da70552dcbecaa4e81e
https://doi.org/10.1080/10543406.2021.1895193
https://doi.org/10.1080/10543406.2021.1895193
Autor:
Gaohong Dong, Bo Huang, Johan Verbeeck, Ying Cui, James Song, Margaret Gamalo‐Siebers, Duolao Wang, David C. Hoaglin, Yodit Seifu, Tobias Mütze, John Kolassa
Publikováno v:
Pharmaceutical statisticsREFERENCES.
Conventional analyses of a composite of multiple time-to-event outcomes use the time to the first event. However, the first event may not be the most important outcome. To address this limitation, generalized pairwise comparisons and win statistics (
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::2f3905ff9eb3559e7eaae348aef0ac2c
https://pubmed.ncbi.nlm.nih.gov/35757986
https://pubmed.ncbi.nlm.nih.gov/35757986
Autor:
Ronald J. Portman, Sebastian Weber, Kattayoun Kordy, Robert M. Nelson, Margaret Gamalo-Siebers, Lisa V. Hampson
Publikováno v:
Therapeutic Innovation & Regulatory Science. 53:567-578
The conduct of pediatric clinical trials is legally required, monitored, and encouraged in major geographic areas such as the United States and Europe. However, because pediatric patients are considered vulnerable populations, they should only be enr
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::8d275bc861686389645a3a53dada07f5
https://doi.org/10.1177/2168479019842541
https://doi.org/10.1177/2168479019842541
Autor:
Carl C. Peck, Stephen J. Ruberg, Karen L. Price, J. Jack Lee, Lisa M. LaVange, Frank E. Harrell, Margaret Gamalo-Siebers
Publikováno v:
The American Statistician. 73:319-327
The cost and time of pharmaceutical drug development continue to grow at rates that many say are unsustainable. These trends have enormous impact on what treatments get to patients, when they get t...
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::58999bf8c7942f59194113d7a0268bff
https://doi.org/10.1080/00031305.2019.1566091
https://doi.org/10.1080/00031305.2019.1566091