Clinical success rates for new cancer drugs doubled from the mid-1990s to early-2000s, says Tufts CSDD

Clinical success rates for new cancer drugs doubled between the mid-1990s to the early 2000s, while the number of new cancer drugs entering clinical testing increased 50 percent during the same time, according to an analysis recently completed by the Tufts Center for the Study of Drug Development.

Clinical success rates - which reflect the share of investigational new compounds entering clinical testing that eventually obtain marketing approval from the US Food and Drug Administration - rose from 9.9% in the mid-1990s to 19.8% in the early-2000s, the study found. The clinical success rate for new cancer drugs entering clinical testing over the entire study period was 13%.

"That success rates increased during the 12 years we examined suggests, while drug development remains highly complex, drug companies are making headway in improving the development process," said Joseph DiMasi, Tufts CSDD director of economic analysis, who served as principal investigator on the study. He added: "Lower transition rates between Phase I and Phase II studies, and between Phase II and Phase III studies, suggest that early termination of less promising candidates early on helps improve later transition rates."

Mr DiMasi said a similar study he previously conducted found that, for the top 50 drug companies, clinical approval success rates for self-originated compounds across all therapeutic areas that entered clinical study during the same period ranged from 14% to 18%.