Increasing competition for trial sites and CROs that can yield reliable, high-quality data is raising the costs of clinical trials, according to a recent survey from Cutting Edge Information.
Pharmalot reported that 32% of those surveyed pointed to higher costs for enrolling patients and 25% cited vendor fees. Expenses for recruiting trial sites was named by 14%, followed by 12% who fingered technology costs, according to the survey of 21 drug makers, 12 biotechs, nine device makers and 23 CROs.
Meanwhile, staffing for drug development is rising. For instance, phase IV staffing increased by 85% from 2008 to 2011, while phase IIIa doubled. Phase IIIb staffing rose 57%, phase II staffing jumped 106% and phase I staffing spiked 108%. One big reason – more clinical research associates. In 2008, the average phase II trial employed 3.6 CRAs, but that rose to 9 in 2011. The average ratio of CRAs per site was 10 in phase IIIb and 6.3 in phase IIIa.
As for the average per-patient trial costs across all therapeutic areas, in phase I, costs rose from $15,023 in 2008 to $21,883 in 2011. Phase II cost rose from $21,009 to $36,070. In phase IIIa, the cost increased from $25,280 to $47,523 and for phase IIIb, cost jumped from $25,707 to $47,095. Phase IV expenses rose from $13,011 to $17.042.
“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,” Cutting Edge COO Adam Bianchi told Pharmalot. “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.”
More clinical trial work is being outsourced. For phase I trials, 58% is now outsourced, compared with 35% in 2008. In phase II, the figure is 63%, up from 36%. In phase IIIb, 54% is outsourced versus 46%, and in phase IV, 51% is now outsourced, compared with 43% three years ago.
The recent average cost per patient for a cardiovascular trial in phase IIIa was $21,750, and $6,830 in phase IIIb. The cost for phase II was $33,700. In oncology, the average per patient trial cost for phase IIIa was $57,207 and $65,900 for phase IIIb. For phase II, the average cost was $73,303. For drug to treat central nervous system disorders, phase IIIb costs were $41,824 and phase IIIa costs were $33,768, on average per patient. Phase II was $28,197. And for diabetes, phase IIIb costs were $10,700, phase IIIa costs were $12,667 and phase II costs were $8,854.