Some therapeutic agents are likely to be effective in a specific population of patients who may have an underlying disorder that is responsive to the manipulation of dose levels of the same agent or several different agents. AS per the study it indicates that there are basically three kinds of enrichment: noise reduction, prognostic and predictive. Enrichment wonât save a drug that doesnât work, but it will help find one that does. An enrichment design should enhance signals of effectiveness. Instead of an unselected group of patients, enrichment design is of interest to identify the patients in whom the test agent is likely to be beneficial in the early phase of the trial. The patients with drug efficacy identified at the enrichment phase are then randomized to receive either the efficacious dose of the test agent or the matching placebo. The concept of enrichment design is illustrated in three clinical trials in the areas of Alzheimerâs disease and arrhythmia. Vs Chow SC, A Note on Design and Analysis of Clinical Trials.
Last date updated on July, 2014