Info & Opinion
December 9, 2013
With news about big data, Aetna, Covance, GNS, Scrip, Quintiles, PPD, Icon, BioClinica, Merge, Medidata and GSK.
With news about FDA, CTMS, PMG Research, Inclinix, EMA, Hemofarm, Parexel and the Korea Drug Development Fund
David Underwood of Quanticate says some firms are giving short shrift to the basics of clinical trials
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There are people who feel clinical trials are artistic endeavors. That the same practices which drive efficiency in other industries cannot be applied to clinical development, any more than efficiency is germane to making a sketch or a symphony. Barry Templin is emphatically not one of those people.
Associate director of clinical programs at Abbott Vascular, Templin is a mechanical engineer by training. He views clinical trials analytically, overseeing roughly $100 million in projects every year. The group's profile within parent Abbott has been rising since the company acquired selected assets from Guidant in 2006.
Templin believes trials can be scrutinized and improved. "My view is, it's a project. It can be optimized," he says. "There are repetitive aspects that you do every time." A sample project: Spirit IV, a 3,690-patient trial proceeding at 65 sites and concluding in 2013. There's a news release about it here.
Abbott appears to have a wide-ranging approach to efficiency. The firm elected to dive into not just electronic data capture (EDC), but electronic everything. Monitoring reports, case report forms, they're all electronic. Among other systems, the company is using Siebel Clinical, part of the Oracle product line, to manage documents and site qualification.
After a recent audit, Templin was relieved that every document was in its proper digital location. "I couldn't imagine the chaos that would have happened had we had to dig through files and boxes," Templin says.
Another example came from noticing longer attorney-related delays. Thanks to a standard master agreement, those delays have now been eliminated. The company trimmed an interval of legal wordsmithing that formerly ate up precious time on many projects.
Abbott Vascular recently brought on four sites for a small trial, and Templin never heard a thing from colleagues about attorney-related delays. "I didn't hear a peep about contracting issues," he says. "It's a nonissue now."
Other gains have come with technology. Templin notes that Abbott Vascular is familiar with stent trials, having run them for a decade. But the company is still seeing new opportunities to be efficient using software from ClearTrial, which prepares detailed budgets and operational plans.
"Once we get started in a trial, we typically hit our time lines pretty close to what we anticipate," Templin says. There's no telling how the decisions of regulatory bodies will affect a trial, he concedes. But once Abbott has a green light to proceed, its trials run on time and on schedule.
That's especially noteworthy because one of Abbott's largest, highest-profile studies is a combination drug-device project. The company is evaluating a drug-coated stent that slowly dissolves into the human body. In contrast to the earlier bare metal or drug-coated stents, that is, such devices almost completely disappear. "We are on the critical path for product approval," he notes. "The race now is to the next generation. The design of that trial is going to be much more complicated than a bare metal stent [trial] in the 1990s. Our trials are definitely becoming more complex."
Abbott rival Boston Scientific is engaged in a similar quest, so even a relatively minor delay in the program is not satisfactory to Templin's colleagues or senior managers. Says Templin: "Three months is not acceptable around here. A three-month delay? That's basically 25 percent of the project. If we need more money, more heads, whatever it is, we'll get it."
At this point, Templin cannot imagine going back to the world of clinical trial budgets assembled in Microsoft Excel. "We spent so much time trying to get accurate numbers in there that we were in the weeds. I needed a system that made us efficient, fast and accurate. ClearTrial removes some of the manual effort," he says.
Farewell To Spreadsheets
It's not so much a matter of Excel having a fatal defect, although such files do decay under the burden of time and multiple authors. It's more a question of whether Excel is the appropriate tool for planning and budgeting complex multiyear projects. Templin doesn't think so.
"Excel is a flat file. It can only handle so much information," he says. "It couldn't get updated fast enough. There were too many errors." He recalls the program's hourglass spinning interminably. "ClearTrial has taken some of the thinking out of the budget. You enter the variables and it does all the math for you. We've got fifty or so projects in there."
The software has elevated Templin's organizational relationship with the company's finance department. That's thanks to significantly faster turnaround times to supply budgets for both individual trials and entire programs. In an era with tightening financial constraints, his requests for R&D money within Abbott are not viewed as wild guesses. Says Templin: "We've gained a lot of credibility within the financial organization about our ability to be accurate. We can renegotiate contracts to pull in some money. Finance feels like we have control."
One helpful feature, Templin says, is the ability to pivot quickly and assess how to use additional resources. Or, if fewer resources are available, the software identifies the easiest ways to reach targeted levels of spending by program or head count.d9A2t49mkex
"It's much smoother and simpler," he says of the budgeting process. "We can be more accurate. We didn't have time to think strategically before. It was a mad dash. ClearTrial gives us insight into if we stop a project, how much extra resources will we have available?"