V
Vladimir Dragalin
Researcher at GlaxoSmithKline
Publications - 31
Citations - 1319
Vladimir Dragalin is an academic researcher from GlaxoSmithKline. The author has contributed to research in topics: Data monitoring committee & Kullback–Leibler divergence. The author has an hindex of 15, co-authored 31 publications receiving 1242 citations. Previous affiliations of Vladimir Dragalin include Johnson & Johnson.
Papers
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Adaptive Designs in Clinical Drug Development—An Executive Summary of the PhRMA Working Group
TL;DR: Three particular areas where it is felt that adaptive designs can be utilized beneficially are discussed: dose finding, seamless Phase II/III trials designs, and sample size reestimation.
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Twenty-five years of confirmatory adaptive designs: opportunities and pitfalls
TL;DR: A historical overview of the early days, review the key methodological concepts and summarize regulatory and industry perspectives on such designs are provided, and the application of adaptive designs is illustrated with three case studies.
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Adaptive designs for dose-finding based on efficacy–toxicity response
TL;DR: In this paper, a new adaptive procedure for dose-finding in clinical trials when both efficacy and toxicity responses are available is proposed, which uses either Gumbel bivariate logistic regression or Cox bivariate binary model.
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Adaptive Designs: Terminology and Classification:
TL;DR: A general definition of adaptive designs is given, their structure is described, and their classification is provided, mapping them against the drug development process.
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Adaptive seamless Phase II/III designs : Background, operational aspects, and examples
TL;DR: The concept of adaptive designs is introduced and the current statistical methodologies that relate to adaptive seamless designs are described, which describe the decision process involved with seamless designs.