Clinical Trials

■■❚❙❘Chapter 12Equivalence TrialsAmeet Bakhai, Rajini Sudhir, and Duolao WangClinical trials are usually conducted to detect the superiority ofone treatment over another. However, compounds often undergoalterations to either their release mechanism, formulation,or manufacturing process, and some are modified chemically,resulting in related compounds. It can then become necessaryto conduct a trial to compare the altered versus the originalcompound or drug to demonstrate that there has been no lossof effectiveness or increase in side-effects. Such trials areknown as equivalence trials, and their place in the clinicaltrial armamentarium is explained here.113