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Down economy obliges CT to improve efficiency
Protocol complexity increases
Clinical trial (CT) research is moving toward a performance-driven model in which sites increasingly will compete with top-performing U.S. sites and lower-cost sites in developing nations overseas.
At the same time, studies are becoming more complex, which puts a huge burden on sites and is harming their performance, says Ken Getz, MBA, a senior research fellow and assistant professor at Tufts Center for the Study of Drug Development at Tufts University in Boston, MA. Getz also is chair of the Center for Information and Study on Clinical Research Participation in Boston.
"You have a down economy that's putting pressure on all of these different players: sponsors, clinical research organizations (CROs), and sites," Getz explains. "At the same time, sponsors' own portfolios and composition of products require higher efficiency, and these needs are transferred to third parties."
The result is pressure on CT sites to deliver a higher level of efficiency under more difficult and complex programs, he adds.
Research industry statistics clearly show clinical research inefficiency.
Most CT sites in 2008 and 2009 enrolled one or fewer patients, costing the industry an average of $50,000 to open and close each unsuccessful site, says Dave Handelsman, senior industry consultant at SAS Health and Life Sciences in Cary, NC.
"Only about one-third of all sites in a given trial meets or exceeds the enrollment goals of the trial," Getz says. "We know that when looking across a large sampling of studies that it is taking 30% to 40% longer to complete the programs than it did for the prior four-year period, so it's getting slower at a time when speed is even more precious."
Sponsors are trying to change things, but it seems that each change creates more complexity, he adds.
"I've been hearing from sites that they're frustrated with the ways they're introduced to trials and how often they put in effort to prepare for a trial and engage staff to gear up for a study, and then it doesn't happen," he says.
Across every phase of clinical research there has been a dramatic and significant increase in the complexity of protocols, Getz notes.
"We've seen the number of procedures and their frequency rise rapidly, and we've seen the number of eligibility criteria rise rapidly," he explains. "All of this additional complexity is creating a burden on the operations and feasibility of the trials, so it's harder to find people to enroll, and it's harder to keep them in the studies."
CT sites get caught up in the cycle of having to accept studies they should turn down because they need the work and then failing to succeed partly because of the study's complexity.
"Right now the complexity is winning out, and it's actually hurting efficiency," Getz says.
It's difficult for sites to survive in this environment, but it can be done.
For instance, sponsors and clinical research organizations (CROs) are placing more emphasis on sites producing quality data, and some are tracking sites' success rates, Handelsman says.
"There will be more done to identify sites that are real rock stars," he adds. "And sponsors will make sure they're involved in the recruitment process."
CT sites can improve their recruitment numbers by doing groundwork to more accurately predict their enrollment potential before they accept a trial, Handelsman says.
This might also mean asking for a more realistic budget.
Both sites and sponsors could use a model and simulation approach that more accurately predicts the study's likelihood of hitting recruitment and milestones, Handelsman suggests.
Sponsors have a wealth of trial data available, and they are beginning to realize it can be mined for the purpose of informing enrollment and clinical trial site decisions, he adds.
"We're seeing a lot of effort to bring data together to make it more actionable," Handelsman says. "There's a wealth of knowledge out there, and it's an important step."
It helps if sites collect their own performance data. They could use their metrics to better pinpoint their potential recruitment numbers. If their experience shows they would be unable to produce enough subjects for a particular trial, then they can turn it down. Or perhaps their numbers show they could meet enrollment goals and bring in the study on time, but it would be costly to do so.
"It's also about quality and cost," Handelsman says. "Maybe a site could do what they say they're going to do, but it will cost 50% more than a site with less of a track record."
Sites can implement better management controls and more accurately estimate their own resource requirements, Getz says.
"They should do a more realistic estimate of their own budget requirements and pass those on to the sponsor or CRO," he adds.