A prospective combination of phase II and phase III in drug development

DOI10.1007/BF03263544MaRDI QIDQ478229zbMATH OpenOpenAlexFDO

Authors Antonella Bacchieri, Adelchi Azzalini

Publication date 3 December 2014

Published in Metron (Search for Journal in Brave)

Full work available at URL https://doi.org/10.1007/bf03263544

zbMATH Keywords

skew-normal distributionlikelihood-based inferenceadaptive designsconditional powerdrug development

Mathematics Subject Classification ID

Applications of statistics to biology and medical sciences; meta analysis (62P10) Sequential statistical design (62L05)

Recommendations

• Theory of drug development
• Phase 2 and 3 Combination Designs to Accelerate Drug Development
• A Parallel Phase I/II Clinical Trial Design for Combination Therapies
• Confirmatory seamless phase II/III clinical trials with hypotheses selection at interim: general concepts
• A Bayesian seamless phase I–II trial design with two stages for cancer clinical trials with drug combinations

Cites work

• Definition and probabilistic properties of skew-distributions.
• Evaluation of Experiments with Adaptive Interim Analyses
• Graphical models for skew‐normal variates
• On the Unification of Families of Skew-normal Distributions
• Phase 2 and 3 Combination Designs to Accelerate Drug Development

Cited in

(9)

• A closed-form filter for binary time series
• Phase 2 and 3 Combination Designs to Accelerate Drug Development
• Statistical methodology for screening studies with qualitative/quantitative mixtures
• scientific article; zbMATH DE number 7625183 (Why is no real title available?)
• Bayesian Conjugacy in Probit, Tobit, Multinomial Probit and Extensions: A Review and New Results
• Records for time-dependent stationary Gaussian sequences
• Some properties of the unified skew-normal distribution
• Interphase Clinical Trials: Phase III/Phase IV
• Expressions for moments of order statistics and records from the skew-normal distribution in terms of multivariate normal orthant probabilities

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Uses Software

• R

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