Rapid rise of clinical trial costs: a Survey

According to a recent survey from Cutting Edge Information, clinical trials costs are on a rapid rise due to growing competition for trial sites and CROs that can yield reliable high-quality data.

In a report by Pharmalot, 32% and 25% of those surveyed cited higher costs for enrolling patients and paying vendor fees, respectively. A survey of 21 drug makers, 12 biotechs, 9 device makers, and 23 CROs revealed that 14% of the expenses were attributed to recruiting trial sites and 12% for technology costs.

In the interim, recruitment for drug development is also on the rise. From 2008 to 2011, staffing for Phase IV trials increased by 85% while that for Phase IIIa trials doubled.

Staffing for Phase IIIb, Phase II, and Phase I trials rose to 57%, 106%, and 108%, respectively. One big reason – more clinical research associates. While an average Phase II trial employed 3.6 CRAs in 2008, that number increased to 9 in 2011. The average CRA per site ratios were 10 and 6.3 for Phase IIIb and Phase IIIa trials, respectively.

From 2008 to 2011, the average per-patient trial costs across all therapeutic areas rose from $15,023 to $21,883 for Phase I, $21,009 to $36,070 for Phase II, $25,280 to $47,523 for Phase IIa, $25,707 to $47,095 for Phase IIIb, and $13,011 to $17.042 for Phase IV.

Cutting Edge COO, Adam Bianchi, told Pharmalot: “Everybody is working hard to control those costs. The biggest thing on the horizon is trying to get a handle on earlier go-no-go decisions. The competition for quality sites is creating a lot of headaches. You have a greater number of sites worldwide than ever before, but not all are yielding quality data that companies want.”

Compared to 2008, more clinical trial work is being outsourced now. The figures for 2008 and 2011 stand at 35% vs 58% for Phase I, 36% vs 63% for Phase II, 46% vs 54% for Phase IIIb, and 43% vs 51% for Phase IV trials.

The recent average per-patient costs for:

(a) Cardiovascular trials were $33,700 for phase II, $21,750 for phase IIIa, $6,830 for phase IIIb;
(b) Oncology trials were $73,303 for Phase II, $57,207 for Phase IIIa, and $65,900 for Phase IIIb;
(c) Drugs treating CNS disorders were $28,197 for Phase II, $41,824 for Phase IIIb, and $33,768 for Phase IIIa; and
(d) Diabetes trials were $8,854 for Phase II, $10,700 for Phase IIIb costs, and $12,667 for Phase IIIa.