The 2008 Clinical Trials Congress had deep tracks of sessions around patient recruitment and trial budgeting. The familiar paradox is that as more sponsors seek more patients, patients become even more scarce. But now that conventional wisdom seems to be upside down. Instead of the familiar refrain of more patients, could fewer trials be a remedy?

“There are way too many studies out there,” says Scott Jensen, manager of global clinical budgeting and contracting at Lilly. “We have to get better at focusing our protocols.”

Starting Too Fast

Jensen said the typical rush to start trials can compress the budgeting process and mask the likely success of a trial from an operational or financial perspective. Throughout the industry, he says, there is frequently insufficient time to determine if a particular site will find the patients it needs or, for that matter, whether a specific site will break even by participating in a project. “These assumptions are absolutely critical,” says Jensen. “I want to challenge all of us to rethink the assumptions.”

One assumption is that simply enlisting a particular investigator, by itself, is a good thing. What matters more, says Jensen, is that clinician’s ability to attract and retain patients. “The industry cannot afford to continue funding a third of our sites at zero patients or one patient enrolled. We’ve got to be more efficient than that.”

Aside from the inherent advantages of judiciously picking sites and investigators that can really fill the study, there is the matter of federal scrutiny. Why did Dr. Smith receive twice as much as Dr. Jones? Did Dr. Evans actually complete the work for which she was paid?

Out-of-Pocket Expenses

Oversight of government or industry payments to U.S. hospitals is nothing new. But Jensen said the systems and the contracts have to be able to demonstrate that for every trial, rules and procedures—not favoritism—drove reimbursement. “Can you support and defend each transaction?” he asked “Does the payment look reasonable and appropriate? This is supposed to be an arms-length transaction.”

There was a similar message from Dan Ulrey, president of Midwest Clinical Support Inc. He was presenting the slides of another speaker called away by family illness, but made the material his own. Ulrey took the position of the site, and noted that it may take thousands of dollars to prepare for a study before a single patient is enrolled. Often as not, if the trial is canceled, the investigator has an out-of-pocket loss.

Unshared Protocol

Worse, it’s all but impossible for the site to determine if a project is attractive, simply because the protocol is not supplied at an early juncture. “I have never seen, since 1997, a draft protocol given to a potential investigator who is considering enrolling in your study,” he said.

The result, not surprisingly, is a notoriously disenchanted landscape of clinical investigators who work on one or two industry-sponsored projects before throwing up their hands. The perseverance of a few productive sites borders on the miraculous, but the trends are not favorable, Ulrey observes. “We’re going to pay for this as an industry,” he says. “We’re going to pay dearly. There are going to be a lot of pharmas consolidated. There are a lot of jobs that are going to be consolidated.”

A Glut?

Like Lilly’s Jensen, Ulrey believes there are simply too many trials chasing too few patients. Said Ulrey: “You’re marketing protocols that shouldn’t be marketed. I think we owe the FDA 14,000 safety studies. Two years from now, it will be 40,000 studies. What are we doing?”

All too often, he says, there is little real information about whether a site is likely to really find patients in the needed numbers. “You’re supposed to be a metric driven business. Data, data, data,” says Ulrey. “Where’s the data? Identifying producing sites is the most convoluted thing I’ve seen in my life.”

Ulrey was dismissive of some media budgets to find patients, finding them inadequate. “Do not give a site $5,000,” he advises “Give them $50,000 or walk away from it. You’re throwing money away.”

We’re sympathetic to the eminently logical view that there are too many trials. But it calls to mind a bit of Shakespeare. “More honor’d in the breach than the observance,” Hamlet says. Recommending fewer, more targeted trials will be easier than turning back the many regulatory, scientific and competitive pressures to launch studies.