Phase III Fullscale comparative treatment evaluation

Phase III trials are the first, direct comparison between the new treatment and the current standard (which may sometimes be no active treatment). In most cases, patients will be allocated to the alternative treatments using a chance mechanism, leading to randomized controlled clinical trials (often referred to simply as RCTs). 'Randomized' means that patients are allocated treatments within the trial prospectively, by an unpredictable (usually random) means. ' Controlled implies comparative in some sense, but does not always imply 'randomized' or prospective. Indeed as we discuss later, something referred to as a randomized trial may not in fact mean truly randomized. The randomized controlled phase III trial is the established gold standard for determining the relative value of a new therapy, and it will be a rare treatment indeed which becomes established therapy without having successfully passed through at least one randomized phase III trial. Chapter 4 is devoted to this most important phase; here we discuss the importance of randomization and the problems associated with non-randomized comparisons.

0 0

Post a comment