Pharmacodynamic Endpoints as Clinical Trial Objectives to Answer Important Questions in Oncology Drug Development

Since the earliest days of oncology drug development, mechanism of action (MOA) has served as a guiding principle for: (i) selecting experimental agents with novel MOAs to advance into clinical trials, (ii) setting dose schedules of investigational agents, (iii) selecting patients who enrich early clinical trial populations with potential responders, and (iv) combining drugs with non-cross-resistant MOAs to generate new regimens. The use of pharmacodynamics (PD) during clinical drug development primarily involves the strategy and timing of using MOA knowledge to complement, but not supplant, clinical information in decision making —a form of “rational drug development” that measures the actual molecular target response instead of predicting it from estimates of drug concentration in the tissue [1–3].
Source: Seminars in Oncology - Category: Cancer & Oncology Authors: Source Type: research