Zobrazeno 1 - 10 of 21 pro vyhledávání: '"Junjing Lin"'
1
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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3
Ensuring exchangeability in data‐based priors for a Bayesian analysis of clinical trials
Autor: Junjing Lin, Margaret Gamalo-Siebers, Ram Tiwari
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
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4
Propensity‐score‐based meta‐analytic predictive prior for incorporating real‐world and historical data
Autor: Veronica Bunn, Jianchang Lin, Bradley Hupf, Meizi Liu, Junjing Lin
Publikováno v: Statistics in Medicine. 40:4794-4808
As the availability of real-world data sources (eg, EHRs, claims data, registries) and historical data has rapidly surged in recent years, there is an increasing interest and need from investigators and health authorities to leverage all available in
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::6a477d71e01a36e694b6d1367644e25c
https://doi.org/10.1002/sim.9095
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6
Matching within a hybrid RCT/RWD: framework on associated causal estimands
Autor: Junjing Lin, Guanglei Yu, Margaret Gamalo
Publikováno v: Journal of biopharmaceutical statistics.
As the regulatory environment becomes progressively receptive toward utilizing real-world evidence, a spectrum of real-world data incorporation techniques in trial conduct and analysis has seen increasing interest and adoption in different stages of
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::7c3ccc6fffce5c2ab12387272232b4f4
https://pubmed.ncbi.nlm.nih.gov/35929973
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8
Dynamic incorporation of real world evidence within the framework of adaptive design
Autor: Junjing Lin, Ran Liao, Margaret Gamalo-Siebers
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
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9
Incorporating propensity scores for evidence synthesis under bayesian framework: review and recommendations for clinical studies
Autor: Jianchang Lin, Junjing Lin
Publikováno v: Journal of Biopharmaceutical Statistics. 32:53-74
The amount of real-world data (RWD) available from sources other than randomized-controlled trials (RCTs) has grown ultra-rapidly in recent years. It provides the impetus for generating substantial evidence of effectiveness and safety from both RCTs
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::51a936762b31dc728f1e24f461daea48
https://doi.org/10.1080/10543406.2021.1882481
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10
A note regarding the special issue on innovative design and analysis of complex clinical trials and opportunities for future research
Autor: Junjing Lin, Yodit Seifu, Margaret Gamalo-Siebers
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
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