Zobrazeno 1 - 10
of 59
pro vyhledávání: '"Vladimir Dragalin"'
Autor:
Vladimir Dragalin
Publikováno v:
Systems modelling and optimization ISBN: 9780203737422
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::08e0705f392fe4b91c8e75802c5b0b81
https://doi.org/10.1201/9780203737422-41
https://doi.org/10.1201/9780203737422-41
Autor:
Vladimir Dragalin, Elena Polverejan
Publikováno v:
Statistics in Biopharmaceutical Research. 12:142-154
Draft ICH E9(R1) Addendum on “Estimands and Sensitivity Analysis in Clinical Trials” provides different strategies for addressing intercurrent events in defining an estimand and describing the trea...
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::9f594c833dc34e441eccf67427cbdd2f
https://doi.org/10.1080/19466315.2019.1689845
https://doi.org/10.1080/19466315.2019.1689845
Autor:
Parvin Fardipour, Sergei Leonov, Alan Hartford, Vladimir Dragalin, Inna Perevozskaya, Yili L. Pritchett, Alun Bedding, Greg Cicconetti, Cristiana Mayer
Publikováno v:
Statistics in Biopharmaceutical Research. 11:325-335
Adaptive clinical trials are the cornerstone of modern drug and device development. The most recent US legislation calls for higher efficiency in designing clinical trials with emphasis on expandin...
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::08ccff5df7f1b4980ebbdce1c200c691
https://doi.org/10.1080/19466315.2018.1560359
https://doi.org/10.1080/19466315.2018.1560359
Autor:
Tobias Mielke, Vladimir Dragalin
Publikováno v:
Statistical Papers. 60:355-371
Objectives in Phase II drug combination studies are to estimate the efficacy response surface for the combination of doses of different drugs and to select the most efficient combination for the final Phase III clinical trial. One problem is to find
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::5ab25f34fd544d16bca4172a1029a240
https://doi.org/10.1007/s00362-018-01073-9
https://doi.org/10.1007/s00362-018-01073-9
Publikováno v:
Statistics in Medicine. 35:364-367
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::be1c9ce19f56a6af02e48595cbd4cdbf
https://doi.org/10.1002/sim.6823
https://doi.org/10.1002/sim.6823
Publikováno v:
Pharmaceutical Statistics. 15:109-122
In clinical trials, continuous monitoring of event incidence rate plays a critical role in making timely decisions affecting trial outcome. For example, continuous monitoring of adverse events protects the safety of trial participants, while continuo
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::34d58b9008eb6b8aeef296c2ce816c90
https://doi.org/10.1002/pst.1727
https://doi.org/10.1002/pst.1727
Autor:
Matilde Sanchez, Zoran Antonijevic, Paul Gallo, Eva Miller, John Loewy, Sandeep Menon, Caroline Claire Morgan, Christy Chuang-Stein, Vladimir Dragalin
Publikováno v:
Therapeutic innovationregulatory science. 47(4)
In this paper, the authors express their views on a range of topics related to data monitoring committees (DMCs) for adaptive trials that have emerged recently. The topics pertain to DMC roles and responsibilities, membership, training, and communica
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d9e08549aead9d010336cc0443475b6f
https://pubmed.ncbi.nlm.nih.gov/30235521
https://pubmed.ncbi.nlm.nih.gov/30235521
Publikováno v:
Therapeutic innovationregulatory science. 48(1)
The International Society for CNS Clinical Trials and Methodology (ISCTM) Adaptive Design Working Group (IADWG) designed a case study simulation exercise to compare the value of traditional versus adaptive design approaches to phase II clinical trial
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::03aee7ad410ca330383dfcc40e8fa741
https://pubmed.ncbi.nlm.nih.gov/30231421
https://pubmed.ncbi.nlm.nih.gov/30231421
Publikováno v:
Statistics in Medicine
‘Multistage testing with adaptive designs’ was the title of an article by Peter Bauer that appeared 1989 in the German journal Biometrie und Informatik in Medizin und Biologie. The journal does not exist anymore but the methodology found widespre
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::7e005d6ad70003b758b9d6badfb55515
https://doi.org/10.1002/sim.6472
https://doi.org/10.1002/sim.6472
Autor:
Vladimir Dragalin, Tobias Mielke
Publikováno v:
Handbook of Methods for Designing, Monitoring, and Analyzing Dose-Finding Trials ISBN: 9781315151984
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::b252574f73785dc953eb3a64d5ecf704
https://doi.org/10.1201/9781315151984-14
https://doi.org/10.1201/9781315151984-14