Clinical Trials

■■❚❙❘Chapter 2Uncontrolled TrialsJoseph Kim, Dorothea Nitsch, Duolao Wang,and Ameet BakhaiUncontrolled clinical trials are defined as clinical studieswhere new treatments are studied in the absence of a controlgroup. As a result, these studies provide less information onthe therapy than controlled trials. Nonetheless, uncontrolledtrials play an integral part in the evaluation of novel therapies,particularly in the early stages of clinical research wherethey are used to help justify and plan large-scale clinicaltrials. In this chapter, we review the merits and limitationsof uncontrolled trials, and describe their potential usefulnessin clinical research.15