Zobrazeno 1 - 10 of 196 pro vyhledávání: '"Margaret Gamalo"'
1
Periodical
An Interview with Margaret Gamalo, Editor of JBS.
Publikováno v: Amstat News. Dec2020, Issue 522, p8-13. 6p.
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2
Extent of safety database in pediatric drug development: types of assessment, analytical precision, and pathway for extrapolation through on-target effects
Autor: Margaret Gamalo, Yihua Zhao, Aijun Gao, Jingjing Ye, Junjing Lin, Eiji Eshida, YounJeong Choi, Robert Nelson
Publikováno v: Journal of Biopharmaceutical Statistics. :1-16
Pediatric patients should have access to medicines that have been appropriately evaluated for safety and efficacy. Given this goal of revised labelling, the adequacy of the pediatric clinical development plan and resulting safety database must inform
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e7ce8da3a3c5df424d057f6225e7c572
https://doi.org/10.1080/10543406.2023.2172425
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5
Design of paediatric trials with benefit-risk endpoints using a composite score of adverse events of interest (AEI) and win-statistics
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
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6
Strategies to facilitate adolescent access to medicines: Improving regulatory guidance
Autor: Christina Bucci-Rechtweg, Angeliki Siapkara, Kristina An Haack Bonnet, Solange Corriol Rohou, Elin Haf Davies, Martine Dehlinger Kremer, Margaret Gamalo, Carmen Moreno, Robert M Nelson, Rhian Thomas Turner
Publikováno v: Clinical Trials. 20:13-21
Background: Historically, pediatric medicines are developed after adult trials are completed, even when identical drug targets and disease similarities exist across the populations. This has resulted in significant delays in the authorization of medi
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::269c4fe54475265e57b18d1fec0eb398
https://doi.org/10.1177/17407745221132302
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7
The win odds: statistical inference and regression
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
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8
Win ratio approach for analyzing composite time‐to‐event endpoint with opposite treatment effects in its components
Autor: Ran Liao, Sujatro Chakladar, Margaret Gamalo
Publikováno v: Pharmaceutical Statistics. 21:1342-1356
There is an increasing interest in the use of win ratio with composite time-to-event due to its flexibility in combining component endpoints. Exploring this flexibility further, one interesting question is in assessing the impact when there is a diff
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::552f26a5d9f447cf7aa21018a4d2c704
https://doi.org/10.1002/pst.2248
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9
Real-World Data as External Controls: Practical Experience from Notable Marketing Applications of New Therapies
Autor: Rima Izem, Joan Buenconsejo, Ruthanna Davi, Jingyu Julia Luan, LaRee Tracy, Margaret Gamalo
Publikováno v: Therapeutic Innovation & Regulatory Science. 56:704-716
Real-world data (RWD) can contextualize findings from single-arm trials when randomized comparative trials are unethical or unfeasible. Findings from single-arm trials alone are difficult to interpret and a comparison, when feasible and meaningful, t
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::df24aa0758fd7bb1588ea74060982083
https://doi.org/10.1007/s43441-022-00413-0
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10
Power priors with entropy balancing weights in data augmentation of partially controlled randomized trials
Autor: Guanglei Yu, Yuanyuan Bian, Margaret Gamalo
Publikováno v: Journal of Biopharmaceutical Statistics. 32:4-20
In pediatric or orphan diseases, there are many instances where it is unfeasible to conduct randomized and controlled clinical trials. This is due in part to the difficulty of enrolling a sufficient number of patients over a reasonable time period to
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0504f114bd917ec3e68c52937bb60ccf
https://doi.org/10.1080/10543406.2021.2021226
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