Gaps in patient recruitment are a bit like the U.S. shortage of engineers. Both are chronic, perennial problems that appear insoluble.

Year after year, many clinical trials lurch forward with iffy recruitment. Some trials, late in the day, are beneficiaries of additional funds to meet their recruitment targets. But on an industry-wide level, it’s not exactly a well-oiled system.

This is just the way it has to be, right? Maybe not.

Acurian has been doing data-driven patient recruitment for a decade. With backers that include JP Morgan Partners and Merck Capital Ventures, Acurian also offers advertising services and technology to track what happens with campaigns in real time.

Dashboard

Working only on U.S. trials, Acurian relies on a proprietary database of past industry projects and 50 million American patients. That allows it to predict how much advertising, how many phone calls, how many pieces of direct mail will be required. “Our clients have a road map,” says Roger Smith, Acurian’s VP of operations and technology. He’s referring to a dashboard that customers can access online. “It’s a quantitatively based project plan.”

He goes on to say that Acurian’s success and the recruitment goals of a sponsor are not “linked” in some nebulous rhetorical sense. On a majority of projects, they’re connected in hard economic ways. “We only get paid when we deliver the patient to a certain agreed milestone,” Smith explains.

Generally the milestone is defined as a patient reaching randomization. “You tend to be unaligned when you’re not in the boat together, both vendor and sponsor,” says Smith. Acurian’s competitors, he says, typically charge for time and materials. So they make money whether the trial hits its recruitment target or not. Smith adds that his team is undaunted by recruiting for studies of Parkinson’s disease, Alzheimer’s disease, diabetes or other conditions where patients are scarce.

Bad News

That’s because Acurian has high confidence in its projections. The firm believes its accumulated expertise helps it make more accurate estimates that will not be whipsawed by the nuances of geography, therapeutic area or other factors. But that doesn’t mean it’s easy to deliver the news about what a recruitment campaign will cost.

“We kind of are a bad-news-first organization,” says Smith. “We are honest to a fault. We come in and say, ‘this is what we think it is going to cost. Here is our experience. We think it’s going to be expensive.’ There is a shock and awe. We are giving them the actual cost per patient.”

Using the company’s system, any trial’s use of advertising and its telephone call centers are united. In real time, via the web, the company allows its clients to monitor which ads have run in which locations and see how many patients have finished each stage of the process. “We’re set up for total transparency,” says Smith. If Acurian is working in tandem with another recruitment approach, and its own push is not working well, it recommends switching off the Acurian campaign.

Central Solution

At many sponsors, Smith says, there are still lingering doubts about the virtue of central recruitment at all. “We struggle against the general kind of groan that comes around when people need to go to central recruitment,” he says. “They think ... ‘expensive, unknown result,’ and how is this going to reflect on me as a trial organizer?” 

Even so, Smith says the overall acceptance of central recruitment is changing. “The tide has turned slightly,” he says. “[Sponsors] were adamantly against it 3-4 years ago. They thought they didn’t need it.”

Smith is generous about it, but his perspective is that the effects of a delayed trial may not be appreciated at all levels of the sponsor community. Some individuals may have mundane contractual concerns or territorial issues that are less significant than the big picture. “There are a million costs involved in not getting the trial done on time,” he says.

White Space

There is a bit of good news. Fewer customers are coming to Acurian in crisis mode, in the middle of a project with recruitment off anticipated levels. Such work formerly represented perhaps 70 percent of its projects. Now that share is down to 40 percent, with the remainder of customers using Acurian proactively, at project inception. Says Smith: “We’re able to show them that if they start us with their overall study start, we are going to be able to close them early.”

Lauding Acurian’s Jill Pellegrino, manager of quantitative analytics, Smith notes that the company’s model (developed by her) has extensive insight into the time between key trial milestones, such as a patient’s request for information and when she actually shows up in the clinic. That affords a granular simulation of the trial’s recruitment that accounts for the time and probability of each event, for each patient, leading to the patient being enrolled. Acurian is now bundling the insights from its system into its existing offering to “offer customers enhanced predictive and analytical services for patient recruitment campaigns at no additional cost,” this press release says.

In some cases, Smith reports, Acurian prefers to work on multiple protocols from the same sponsor. That can raise the chance that a given budget will locate even more patients. A patient who is not suitable for Trial #1 may be appropriate for Trial #2. “We love it when a client gives us a program of protocols,” says Smith. “It is a much more cost-effective thing for them.”

Editor’s note: Earlier this week, Acurian adjusted its services to offer a pay-for-performance element in advertising aspects of recruitment campaigns. Here’s a news release.

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