From the Pharmalot blog yesterday, Big Pharma is facing the dual problem of emptying pipelines and rising costs for developing new drugs - largely from increasing costs of doing trials. Why? There is increasing competition for trial sites and clinical research organizations that can yield reliable, high quality data, according to a recent survey of 21 drugmakers, 12 biotechs, nine device makers and 23 contract research organizations.
Those surveyed pointed to higher costs for enrolling patients, higher vendor fees and expenses for recruiting trial sites, and technology costs. Staffing for drug development is also rising. 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.
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.
So we not only can't find enough new drugs, but we are also having trouble finding quality sites to cost-effectively test them. More cheery news from the drug development front.
Posted by Bruce Lehr July 28th 2011.