Examining heterogeneity in phase II trial designs may improve success in phase III.

摘要

The failure rate for late-stage clinical trials in oncology is higher than that for any other area of medicine. Between 1991 and 2000, for example, 55% of phase III trials in oncology failed, compared with 30% in infectious disease and 20% in cardiology, according to a study by Schering-Plough and Merck investigators. A separate study from researchers at Princess Margaret Hospital in Toronto estimated that between 1998 and 2003, 85% of the phase III trials that tested new therapies for solid tumors failed to meet their primary endpoint.