2. Fundamentals of Clinical Trials

  1. Guosheng Yin

Published Online: 9 JAN 2012

DOI: 10.1002/9781118183335.ch2

Clinical Trial Design: Bayesian and Frequentist Adaptive Methods

Clinical Trial Design: Bayesian and Frequentist Adaptive Methods

How to Cite

Yin, G. (2011) Fundamentals of Clinical Trials, in Clinical Trial Design: Bayesian and Frequentist Adaptive Methods, John Wiley & Sons, Inc., Hoboken, NJ, USA. doi: 10.1002/9781118183335.ch2

Publication History

  1. Published Online: 9 JAN 2012
  2. Published Print: 19 DEC 2011

ISBN Information

Print ISBN: 9780470581711

Online ISBN: 9781118183335

SEARCH

Keywords:

  • clinical trials;
  • pharmacodynamics (PD);
  • pharmacokinetics (PK);
  • statistical methods

Summary

For a better understanding of the statistical issues arising from clinical trials, this chapter introduces necessary concepts and key components that are essential to clinical trial designs. It also gives a brief discussion on pharmacokinetics and pharmacodynamics modeling, as well as the intuition behind phase I-IV clinical trials. In the preclinical studies and early-phase trials, the person needs to understand the pharmacokinetics (PK) and pharmacodynamics (PD) of the drug. Clinical trials must protect participants' safety in the study and satisfy all ethical constraints. Statistical methods and trial designs should utilize all available resources to detect the treatment effect from confounders, reduce bias, and improve precision. Clinical trial designs aim to: eliminate bias, quantify and reduce errors; produce accurate estimates of treatment effects and the associated precision; provide a high degree of credibility, reproducibility, and internal and external validity, and most importantly, influence future clinical practice.

Controlled Vocabulary Terms

hypothesis testing; statistical measures