With myriad industry efforts to accelerate study start-up times, one might think the process of hammering out contracts at the site level would now be speedier than, say, three years ago.
Wrong. The trends are worsening. According to a new study by consulting, benchmarking and analytics firm KMR Group, the time it takes to get a site contract approved averages five to six weeks—no faster than in 2006, the last time the group scrutinized the process.
Alex Lehrman, senior data analyst for KMR, says that that the firm undertook the new study, called the Site Contract Cycle Time Study, at the request of sponsor companies. They subscribe to KMR's services and contribute trial data to the firm's database. The same study had been done in 2006. “They were curious to see how cycle times had changed,” he says. Twelve medium to large pharma companies contributed their data. (Here's a list of all of KMR's clients, nearly all of which are the largest names in the industry.)
Oncology vs. Lipids
In all, KMR had access to several thousand contracts negotiated from 2006 through 2009, and looked at cycle time between the date the first draft of the contract was sent to the site and full execution of that contract.
The study also looked at contract time in various therapeutic areas. Not surprisingly, oncology-trial contracts took twice as long (2.6 months) to execute than lipid and metabolic trials (almost a month, or, specifically, 0.9 months). The study showed that it took longer to get contracts signed at hospitals and academic medical centers (2.3 months is the industry median) than at independent sites (almost a month).
According to KMR's Lyndsey McKay, the oncology contracts take longer as most such studies are undertaken at institutional sites. Also, there are often more patient-related complications that can affect the contract cycle time, she says. This creates a double-whammy effect for oncology-trial contracts.
Larger institutions also had more variance in how long a contract took to execute and wrap up than independent sites did. Geography played a role, too; institutional sites in the Northeast and Midwest were slower with their contracts than those in other regions in the U.S. (KMR did not include contracts at sites outside the U.S.)
But therapeutic area, site size and culture, and geographic region didn't drive all the differences; the sponsors themselves accounted for some of the variation. Lehrman says there are considerable differences in contract-execution times between pharma companies, with some showing consistently better performance. And that could be extrapolated out to the companies' other operations, he says. “The companies that were faster in this area were faster across the board,” says Lehrman.
Is KMR naming names? Of course not; it has to keep subscribers happy and anonymous.
Copies of the study are only available to KMR subscribers. The Chicago-based firm was founded in 1991 as a management consulting firm for the drug development industry. Its main focus was process improvement. But soon the principals realized that better benchmarking was needed to bring about better process improvement. KMR's benchmarking efforts have accounted for most of the firm's work since 1995. Here is a story we wrote last fall about another site-oriented KMR study.
—by Suz Redfearnd9A2t49mkex