2011/09-11: Statistical Methods in Clinical Research

Full one-semester lecture (3h/week) on statistical methods for clinical research. Within biostatistics MSc program at Department of Biostatistics at University of Zurich.

Syllabus

  • Introduction to clinical trials: background and regulatory aspects; observational studies; historical controls; randomized trials; endpoints; study populations; phases of clinical drug development
  • Study designs and sample size computations I: Phase I/II trials
  • Study designs and sample size computations II: Phase III trials
  • Non-inferiority and equivalence trials
  • Subgroup analysis; multiple testing; methods of adjustment
  • Group sequential trials
  • Adaptive Bayesian Designs I: Introduction to applied Bayes statistics (Beat Neuenschwander, Simon Wandel, Novartis)
  • Adaptive Bayesian Designs II: Bayesian Phase I designs in oncology drug development (Beat Neuenschwander, Simon Wandel, Novartis)
  • Cross over trials
  • Diagnostic tests I: phases of medical test development; measures of accuracy for binary tests; empirical ROC curve
  • Diagnostic tests II: parametric and semiparametric estimates of the ROC curve; covariate effects; diagnostic study design and hypothesis testing
  • Measures of agreement for nominal and continuous data
  • Guidelines for reporting the results of clinical research: CONSORT and STARD; $p$-values, Bayes factors, and confidence intervals; reproducibility

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