Today, Lancet ran an editorial asking whether Phase 0 trials will become a “platform for drug development.” The editorial responds to the first published ‘phase 0’ study, this June, in Journal of Clinical Oncology (Kummar et al). These studies involve delivering very small quantities of a new drug to test its properties before giving biologically… Continue reading Phased by Phase 0?
Tag: phase 0
Fazing Phase 0?
Phase 0 studies are a new class of drug trials that involve delivering tiny doses of a new drug to human volunteers to study how the drug is distributed and metabolized in the human body. Both FDA and its European counterpart, EMEA, have recently issued statements encouraging drug companies to consider ‘phase 0’ studies before… Continue reading Fazing Phase 0?