ABSTRACT
In the cancer drug development process, phase I clinical trials focus on identifying the maximum tolerated dose (MTD), which is typically defined as the dose with a toxicity probability closest to the target toxicity rate. Phase I clinical trials are critically important, as the determined MTD will be further investigated in the subsequent Phase II or Phase III trials. Misidentification of the MTD could result in an inconclusive trial, thereby wasting enormous resources, or a trial in which a substantial number of patients would be treated at excessively toxic doses. In addition, if a dose with low toxicity and negligible efficacy is inappropriately selected as the MTD, it may cause researchers to overlook a promising drug.
