Patient-Specific Dose Adjustment in the Cancer Clinical Trial Setting

Clinical trials of new anticancer therapies are critically important tools in the search for more effective cancer treatments. According to the current paradigm for the clinical evaluation of new cancer therapies, (A) the dose of a therapeutic agent is not adjusted to accommodate individual patient differences, and (B) the exploration of a working-dose of new cancer therapies is mainly restricted to phase I trials. Rogatko et al. proposed that (A′) the dose should be finetuned using patient-specific attributes, and (B′) the search for the optimal dose should be extended beyond phase I and into phases II and III.