Use of Healthy Volunteers Drives Clinical Oncology Drug Development Decision Making

The development of noncytotoxic oncology therapeutics has opened the opportunity for clinical investigation beyond cancer patients. Utilization of the healthy-volunteer population has provided valuable safety, pharmacokinetic, drug interaction, and pharmacodynamic data that have greatly aided oncology clinical drug investigation. However, healthy-volunteer studies and application of these data have not yet been optimally employed. Data from healthy-volunteer studies can impact dose, targets, and end points for program focusing. Clinical Pharmacology & Therapeutics (2012); 92 5, 571–574. doi:10.1038/clpt.2012.157