Clinical Trials

7. Statistics

Statistics play a very important role in any clinical trial from design, conduct, analysis, and reporting in terms of controlling for and minimizing biases, confounding factors, and measuring random errors. The statistician generates the randomization code, calculates the sample size, estimates the treatment effect, and makes statistical inferences, so an appreciation of statistical methods is fundamental to understanding randomized trial methods and results. Statistical analyses deal with random error by providing an estimate of how likely the measured treatment effect reflects the true effect (Wang et al., 2006). Two statistical approaches are often used for clinical data analysis: hypothesis testing and statistical estimate.

Hypothesis Testing
Statistical Estimate
Kirkwood B, Sterne J. (2003). Essential medical statistics, 2nd edition. Oxford: Blackwell Publishing.
Altman DG. (1999) Practical Statistics for medical research. London: Chapman and Hall.
Wang D & Bakhai A, editors. (2006) Clinical Trials: A Practical Guide to Design, Analysis and Reporting. London : Remedica.
Chow SC , Liu JP. (1998). Design and analysis of clinical trials: Concept and methodologies. Chichester : John Wiley & Sons.