Zobrazeno 1 - 10
of 66
pro vyhledávání: '"Valerii V. Fedorov"'
Optimal design of experiments with the observation censoring driven by random enrollment of subjects
Autor:
Valerii V. Fedorov, Xiaoqiang Xue
Publikováno v:
Journal of Statistical Theory and Practice. 11:163-178
In clinical studies together with uncertainties associated with observed endpoints we face uncertainties caused by an enrollment process that often can be viewed as stochastic process. If one observes time to event, then the subject exposure interval
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::ea439cc4d20d633403064729b3b88158
https://doi.org/10.1080/15598608.2016.1263808
https://doi.org/10.1080/15598608.2016.1263808
Autor:
Valerii V. Fedorov, Sergei Leonov
Publikováno v:
Platform Trial Designs in Drug Development ISBN: 9781315167756
We discuss how to structure large pharmaceutical projects that include a relatively large number of clinical sub-trials, of which basket, umbrella, and platform trials provide popular examples. Such trials may be unified under the concept of a cluste
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::4f625528aa271bc80152fa35fce4acd0
https://doi.org/10.1201/9781315167756-18
https://doi.org/10.1201/9781315167756-18
Publikováno v:
Therapeutic Innovation & Regulatory Science. 48:20-30
In this paper, the authors describe developments in adaptive design methodology and discuss implementation strategies and operational challenges in early-phase adaptive clinical trials. The BATTLE trial—the first completed biomarker-based Bayesian
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0f15b97c03720e454d46f3dcf63e2e4c
https://doi.org/10.1177/2168479013513889
https://doi.org/10.1177/2168479013513889
Publikováno v:
Journal of Statistical Planning and Inference. 144:81-91
The construction of optimal experimental designs for regression models requires knowledge of the information matrix of a single observation. The latter can be found if the elemental information matrix corresponding to the distribution of the response
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::8f504c3703fe2acd8fc75c05a87ef659
https://doi.org/10.1016/j.jspi.2012.09.012
https://doi.org/10.1016/j.jspi.2012.09.012
Autor:
Valerii V. Fedorov, Tao Liu
Publikováno v:
Journal of Statistical Theory and Practice. 8:30-45
Randomized discontinuation trial (RDT) has gained popularity across a number of therapeutic areas. Oncology is one of the most known. In the simplest case, at the initial open-label stage all patients are treated with the experimental treatment to id
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::3f186d53e4674a67db4de6bc86cd3800
https://doi.org/10.1080/15598608.2014.840492
https://doi.org/10.1080/15598608.2014.840492
Publikováno v:
Communications in Statistics - Simulation and Computation. 41:717-729
We discuss a Matlab-based library for constructing optimal sampling schemes for pharmacokinetic (PK) and pharmacodynamic (PD) studies. The software relies on optimal design theory for nonlinear mixed effects models and, in particular, on the first-or
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::1c28982f32d3afe77b95307b5b04ce97
https://doi.org/10.1080/03610918.2012.625273
https://doi.org/10.1080/03610918.2012.625273
Publikováno v:
Statistics in Medicine. 31:217-234
In dose-finding clinical studies, it is common that multiple endpoints are of interest. For instance, in phase I/II studies, efficacy and toxicity are often the primary endpoints, which are observed simultaneously and which need to be evaluated toget
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0d1f81b6a5dbb112f88266d8943bfac6
https://doi.org/10.1002/sim.4388
https://doi.org/10.1002/sim.4388
Autor:
Steven M. Snapinn, Leonard Oppenheimer, Valerii V. Fedorov, Chi-Hse Teng, Ivan S.F. Chan, Tom Uryniak, John Zhang, Qi Jiang
Publikováno v:
Statistics in Biopharmaceutical Research. 3:476-487
Ideally, a clinical trial should be able to demonstrate not only a statistically significant improvement in the primary efficacy endpoint, but also that the magnitude of the effect is clinically relevant. One approach to address this question, often
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::93177ccf16669390fa63e76c8332345c
https://doi.org/10.1198/sbr.2011.10070
https://doi.org/10.1198/sbr.2011.10070
Autor:
Valerii V. Fedorov
Publikováno v:
Wiley Interdisciplinary Reviews: Computational Statistics. 2:581-589
After a short historical introduction, the properties and numerical methods are the focal point of discussion. Construction of discrete and adaptive designs demand more extended exposition and are beyond the scope of this article but the information
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::11aa4a5269b32e5ff5f5c4f0017febc3
https://doi.org/10.1002/wics.100
https://doi.org/10.1002/wics.100
Publikováno v:
Statistics in Medicine. 29:721-730
Some general points regarding efficiency in clinical trials are made. Reasons as to why fitting many covariates to adjust the estimate of the treatment effect may be less problematic than commonly supposed are given. Two methods of dynamic allocation
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::db05a4fbbecdce32aea3a75e4ab2a9e1
https://doi.org/10.1002/sim.3763
https://doi.org/10.1002/sim.3763