An Introduction to Randomized Controlled Clinical Trials

An introductory methods text on the design, conduct and analysis of RCTs, written for medical researchers and statisticians new to clinical-trial work.

The text takes the reader through the working sequence of a clinical trial — formulation of the research question, choice of comparator, the role of blinding and placebo, randomisation methods including stratification and minimisation, sample-size calculation, the analysis of binary, time-to-event and repeated-measures outcomes, and the interpretation of results in the presence of protocol deviation and missing data. Crossover and equivalence designs are treated alongside the standard parallel-group trial, and the closing chapters address ethics, regulation and the writing of the trial report.

J. N. S. Matthews wrote the volume as a methods reference for clinical investigators working through their first protocol and for applied statisticians moving from observational into trial work, with worked examples and a level of mathematical detail aligned to the Arnold biostatistics list of the period. The volume sat in the Arnold catalogue alongside Multilevel Statistical Models and the Dictionary of Statistics for Psychologists as part of a coherent applied-statistics programme.