One notable aspect of media coverage of clinical trials is the ready acceptance of the cost of a particular clinical research program. In every notable publication, as far as we can tell, the cost of a trial or a research program is confidently said to be so many tens or hundreds of millions of dollars. The amount is accepted without commentary or verification, just as bankers process loan applications.

But given that almost every trial tends to run months or years longer than planned, are the stated costs accurate? Audited? Or just guesses? Part of a marketing program, not R&D? Are the clinical trial budgets really credible inside the companies that generate them?

Shifting Scenarios

All of that came to mind recently when we chatted with Andrew Grygiel, VP of marketing at ClearTrial. The company helps sponsors and contract research organizations (CROs) estimate clinical trial budgets. It allows users to run "what if" scenarios that display the economic consequences of changes to a protocol.

To accomplish that, ClearTrial uses an extensive storehouse of proprietary data. The company is based in the Chicago area and competes with similar databases and trial-planning services at Medidata Solutions, the electronic data capture (EDC) firm. As of this week, ClearTrial has updated its clinical trial costing solution to provide even more granular, detailed estimates. The firm's software runs on the web. The jargon for that approach is software-as-a-service (SAAS). The central appeal of SAAS is that when a digital wrench is improved, every customer benefits at the same moment.

Which is great, except that some sponsors in the clinical trial space are attached to the unique and confidential aspects of their plans and budgets. They can be especially fond of quantifiable insights into the math that defines, say, the arc of site enrollment on a Phase II spinal implant trial in Eastern Europe. So ClearTrial's new software allows for more case-by-case customization of individual trial budgets.

Global Variables

"Studies are becoming more complex," Grygiel says. "Customers are asking for more ability to tweak and control and make adjustments to accommodate the complexity."

The global nature of trials, of course, means that there can be a mix of local currencies. ClearTrial has always supported multiple currencies. But now it can allow any user to enter budget data in any currency, and run reports in that currency. "We maintain an exchange rate table which they can modify to represent their own company's exchange rate," Grygiel says. "When they choose to print a report, they can choose the currency. No matter what value was entered in, it will do the proper calculations."

Customized SAAS

And what if different regions have different rates of patient enrollment or bringing sites on board? The ClearTrial software previously had one overall rate of accrual for sites or patients; now it allows more granular numerical assumptions for different locations. Even enrollment periods can be customized by different regions to build more accurate scenarios.

ClearTrial's approach combines the benefits of an Excel spreadsheet with the advantages of a centrally maintained SAAS offering. Says Grygiel: "We've allowed them to build their own curve. We're giving more flexibility to the company to actually use their own knowledge. It's supplementing our clinical intelligence with their clinical intelligence."

The updated version of the software may be a rare example of the pharmaceutical industry leading, not lagging, the rest of the global technology landscape—as in, say, the drug industry's fond usage of billions of sheets of paper or reliance on document management systems that predate the U.S. space program.

In a tough economy, ClearTrial is also allowing customers to allocate costs with more precision. Users can assign costs to milestone events or specific dates. The company's software was already accurate, Grygiel says. But the improvements mean that no matter what time interval is selected, the cost for that time period will be as precise as possible.

But he takes care to say that while the software now permits custom variables and mathematics to suit the needs of individual customers, the simplicity of the tool has not been sacrificed. "We're not penalizing folks who don't need that level of flexibility and granularity," Grygiel says.

Two Types of Surprise

The context for the improvements, Grygiel says, is an increased climate of vigilance about clinical trial costs. To be sure, some companies are still using the abacus, or even Excel. But in sponsors and CROs that need a more nuanced, modern approach, there are ever-higher expectations.

The idea is that while trial budgets do fluctuate, they should do so within progressively narrower ranges as budget professionals refine their skills and tools. ClearTrial says its software generally predicts the cost of the trial within 1-5 percent of the actual amount. "At one point in time, the variances were very large without a lot of scrutiny," says Grygiel. In some companies, he reports, there are more gimlet-eyed expectations that cost-related surprises, if any, need to shrink over time: "They need to ensure the organization that it is going to be within a certain variance. They need to show consistency there."

The world holds both bad surprises (This thing is going to take three more years) and good ones (We're slightly under budget). ClearTrial says it's able to avoid the first type and stack the odds in favor of the second. A recent project for one customer in large pharma had a one-percent variance on a $130 million budget. Grygiel says that even some industry veterans are surprised by how accurate the company's system is. "The variances that our customers are seeing by using our system are astounding to them," he says.

Here's an earlier article on ClearTrial.

d9A2t49mkex