In this election season, there are too many unkind jokes about politics being the second-oldest profession. But that jesting got us to wonder. What is the second-oldest clinical trial technology?
Paper was invented in China two thousand years ago, so the second-oldest prize belongs to ... interactive voice response (IVR), which depends on a mundane bit of technology called dual-tone multi-frequency (DTMF) signaling. Dating to the early 1960s, and also known as touch-tone dialing, DTMF replaced rotary calling, which is a good thing. If DTMF had never been invented, the pharmaceutical industry would be trying to run 2,000-patient studies with rotary phones.
With DTMF-internet linkages to build—not to mention 250-page specifications to write, program and test—it is no surprise that it takes two months to build an IVR system. Or three. Or at least that was the conventional wisdom until yesterday.
Today, BioClinica announced the launch of a truly new randomization and drug supply management package. Here's a news release. It's called Trident. ClinPage printed the first article on Trident back in 2008.
Ed Tourtellotte, an IVR impresario who sold his firm to BioClinica and still goes into work every day, readily agrees that the software took time to perfect. He credits BioClinica with spending not a little money polishing and validating the application. The core application was done two years ago, he says, but BioClinica knew robust data centers, training and help desks would be need to wrapped around the offering. Unlike competitors, BioClinica can help not just with sophisticated randomizations, but also with the associated drug supply planning.
There is no ambiguity about the robustness and uptime required of an IVR. A large British vendor was bruised by an outage of its services in the niche. "It is a big deal to put an IVR up for use in the world," says Tourtellotte. "It has to be on and up all the time. It has to be great."
Forget about programmers, C++, Cobalt, DTMF. Any savvy clinical person, even a good project manager, should be able to easily set up clinical trial randomization in BioClinica's Trident system. To do that, the individual would simply use a drag and drop, point and click interface. Not bash out a line of code.
To hear Tourtellotte tell it, it's less complex than filling out your grandmother's tax return. "I can do it in about an hour," he says of the time needed to configure a randomization scheme. "When we show it to large pharma, we only get one question: 'When can we have it?' "
Some people will be scratching their heads at the idea of a project manager setting up an IVR system. The thought delights Tourtellotte. He has been consulting and making software in the IVR and drug supply niche for a decade. Says Tourtellotte: "This puts the power in the right person's hands. A project manager understands what it means that this dose occurs at the intersection of a visit schedule or a treatment group. The programmer might not."
As an added benefit, BioClinica is permitting sponsors with precious bits of mathematical about dispensing, randomization or visit schedules, adding them directly into the system. "We allow you to plug in programming code," Tourtellotte says. "We don't want to do that if we can help it. We want to be powerful enough to not rely on programmers."
Tourtellotte is confident that the technology will enable much faster startups of studies. "You can do ten studies in the same time as one," he says. If the Trident graphics on the company's website prove accurate, BioClinica customers will need a single week of configuration, not 12 as in the standard paradigm, to test an IVR system built with Trident. The system can be accessed over the internet and a traditional Bell System copper phone line.
Used in concert with another BioClinica software package, Optimize, the new randomization technology promises even higher sophistication, even bigger synergies. The Optimizer system helps sponsors manage drug supplies in a proactive and sophisticated manner. The goal is not just to avoid outages at clinical sites but also manufacturing too much drug at an astronomical cost.
Leading sponsor firms, he says, now grasp the notion that moving from one crisis to the next is not the best way to run an R&D organization. Says Tourtellotte: "The clinical supply was forced into crisis management due to their lack of planning or dictates to conserve or both. Crisis management had become almost a dominant job description. You can never do anything better because you're managing the last crisis."
Tourtellotte continues: "Clinical supply professionals were the whipping boys of the organization, and they were miserable. I had visibility into that."
Now, he says, a shift is under way. Colleagues of those on the clinical supply teams use the software to visualize and test-drive a particular shift in trial strategy. They want to see whether their mental assumptions will parse out correctly on the ground, in the real world of kits, supply depots and clinic shelves.
Says Tourtellotte: "Everyone gets on the same team. Now that clinical supply organization people have these powerful tools to show the impacts of study design changes, people come to them. 'Can you run this? What do you think of this?' It has been a remarkable reversal."
Especially for biologics trials, Tourtellotte says, there are potentially immense cost savings from gauging the supply correctly. "I am positing that all trials will be simulated at design time," he says.
With the shift to supply simulation, he says, there is some self-sorting of personnel in the clin ops realm. Modern dosing regimens are not always simple to diagram or comprehend. But for those who do understand the concepts and the math, there are expanded career opportunities. "We've allowed the clinical supply folks to elevate themselves to a much more significant and demanding role," he says. "It opens the door. Not everyone can go through."
BioClinica has been a pioneer (thanks to acquired technologies) in combining electronic data capture and IVR. Today's announcement continues that trend, and raises the bar for competitors offering similarly integrated tools.d9A2t49mkex