Tufts' Getz sees growing trial complexity

Growing clinical trial complexity is straining not only biopharma companies in containing drug development costs, but also software providers in meeting the needs of researchers. Research by the Tufts Center for the Study of Drug Development finds more than a 50 percent increase in the effort required to complete clinical trial procedures. The study compares the early-2000s with the mid-2000s.

In terms of numbers of procedures, the Tufts study identifies a 49 percent rise when comparing the two periods: 2000 to 2003 versus 2004 to 2007. For the latter period, the median number of procedures per trial hit 158, says Ken Getz, senior research fellow. He multiplies the procedures figure by the time required for administration, and then that result by the economic value of the administrator's time. The product is total burden, which rose 54 percent between the two periods.

Getz says in an email that software automation tools to help researchers cope with rising trial complexity is an "emerging area" with no type of tool being used extensively. "I am seeing companies explore the use of software to aid in designing protocols that have more reasonable and feasible eligibility requirements."

The results of the trial complexity study complement earlier Tufts findings about the growing burden on regulatory affairs professionals, previously reported. Together they paint a drug-development challenge that is a discouraging business reality to biopharma companies, but a field of opportunity for clinical software providers and service providers.  

- here's the Tufts' announcement