Description
After 13 years since the first edition there are new areas to discuss and more recent trials to be included. Good clinical practice; evaluation of quality of life; measurement of the benefit – risk comparison; determination of cost- effectiveness and cost utility; stopping rules for trials; meta-analysis and subgroup analysis are all new sections in this edition. The references are expanded from 305 to 512 and include the recent advances in trial design, such as the n-of-1 trials and megatrials, and up-to-date examples to illustrate the points made in the 20 chapters. Table of Contents The history of controlled trials; ethical considerations; the objectives of a randomized controlled trial; different trial designs; how many subjects are required for a trial?; how to ensure that the results are free of bias; writing the protocol; recruitment of subjects; information to be collected during a trial; the conduct of the trial – good clinical practice; stopping rules for trials; the variability and validity of results; analysis of the results, subgroup and meta-analysis; the evaluation of subjective well-being and measurement of quality of life; the detection of adverse drug reactions; measurement of the benefit-risk comparison, cost-effectiveness and cost-utility; early trials on new drugs; failure to accept the results of randomized controlled trials; the advantages and disadvantages of randomized controlled trials.
