Statistical Issues in Drug Development

DOI10.1002/9780470723586zbMath1165.62086OpenAlexW4299960933MaRDI QIDQ5445233

Stephen Senn

Publication date: 3 March 2008

Full work available at URL: https://doi.org/10.1002/9780470723586

Mathematics Subject Classification ID

Applications of statistics to biology and medical sciences; meta analysis (62P10) Introductory exposition (textbooks, tutorial papers, etc.) pertaining to statistics (62-01) Medical applications (general) (92C50)

Related Items (19)

Epistemology of causal inference in pharmacology, Towards a framework for the assessment of harms ⋮ Statistical Modeling of Clinical Trials (Recruitment and Randomization) ⋮ Phase I (or Phase II) Dose-Ranging Clinical Trials: Proposal of a Two-Stage Bayesian Design ⋮ E- and R-optimality of block designs for treatment-control comparisons ⋮ Optimal approximate designs for comparison with control in dose-escalation studies ⋮ Recruitment prediction for multicenter clinical trials based on a hierarchical Poisson–gamma model: Asymptotic analysis and improved intervals ⋮ GROUP SEQUENTIAL TESTS WITH OUTCOME-DEPENDENT TREATMENT ASSIGNMENT ⋮ Confidence intervals for dependent data: equating non-overlap with statistical significance ⋮ End-to-end drug supply management in multicenter trials ⋮ The assessment of replication success based on relative effect size ⋮ Beyond the two-trials rule: Type-I error control and sample size planning with the sceptical $p$-value ⋮ Proportional hazards models with random effects to examine centre effects in multicentre cancer clinical trials ⋮ The design of multicentre trials ⋮ The design of multicentre trials ⋮ Simulation of clinical trials: a review with emphasis on the design issues ⋮ Predictive Hierarchic Modeling of Operational Characteristics in Clinical Trials ⋮ Optimal designs for dose-escalation trials and individual allocations in cohorts ⋮ A Five-Decision Testing Procedure to Infer the Value of a Unidimensional Parameter ⋮ Friction and Decision Rules in Portfolio Decision Analysis

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