Clinical Trial Costs Are Rising Rapidly

Clinical Trial Costs Are Rising Rapidly

July 27th, 2011 // 12:44 pm @

As drugmakers scramble to replenish their pipelines, they are encountering all sorts of difficulties, including rising costs for clinical trials. And this is happening across all phases. Why? There is increasing competition for trial sites and clinical research organizations that can yield reliable, high quality data, according to a recent survey.

And so, 32 percent of those surveyed pointed to higher costs for enrolling patients and 25 percent cited vendor fees. Expenses for recruiting trial sites was named by 14 percent, followed by 12 percent who fingered technology costs, according to Cutting Edge Information, which surveyed 21 drugmakers, 12 biotechs, nine device makers and 23 contract research organizations.

Meanwhile, staffing for drug development is rising. For instance, Phase IV staffing increased by 85 percent from 2008 to 2011, while Phase IIIa doubled. Phase IIIb staffing rose 57 percent, Phase II staffing jumped 106 percent and Phase I staffing spiked 108 percent. One big reason – more clinical research associates. In 2008, the average Phase II trial employed 3.6 clinical research associates, but that rose 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. In Phase II, the cost rose from $21,009 to $36,070. In Phase IIIa, the cost increased from $25,280 to $47,523 and in Phase IIIb, cost jumped from $25,707 to $47,095. Finally, 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 chief operating officer Adam Bianchi tells us. “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.

Consequently, more clinical trial work is being outsourced all the time. For Phase I trials, 58 percent is now outsourced compared with 35 percent in 2008. In Phase II, the figure is 63 percent, up from 36 percent. In Phase IIIb, 54 percent is outsourced versus 46 percent, and in Phase IV, 51 percent is now outsourced, compared with 43 percent three years ago.

A few other nuggets: 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.

Source: Pharmalot

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