Should a clinical trial unfold like a beloved family recipe, by rote from a time-honored template passed down through generations of trial operations managers? That is one approach in the industry. Or should the process be dynamic and interactive, driven by actual and simulated data?
That’s the modus operandi of DecisionView, a 50-person firm out of San Francisco. It’s a relatively new entrant into the patient recruitment landscape. Earlier this year, Gartner named it a “cool vendor.” GlaxoSmithKline (GSK), meanwhile, allowed the company to use its name in a press release. The company has assisted on 500 clinical trials in the past twelve months, suggesting its technology is extremely scalable.
More recently, Decision View released a new version of its application, StudyOptimizer. Its speciality is software for modeling patient recruitment in clinical trials. “There isn’t anyone we speak to that doesn’t have a strategic initiative and some pain in this area,” says Linda Drumright, the company’s chief operating officer.
Her company’s software is a tool for operating on more than seat-of-the-pants hunches and guesswork. “It is a solution that brings real value to the market,” says Drumright. “It’s measurable and it’s real. It’s the convergence of predictive analytics and simulation and course correction, being able to visualize where you are and where you’re likely to end up.”
As she sketches out what the company does, it’s clear the goal is to help sponsors anticipate problems, and show them the likely results of changes to their assumptions or key variables across a trial. Should all ten of your new sites be in Brazil? Is the present budget feasible? Must the protocol be changed? How clean is the data?
One customer, she says, used the software and saw a 20 percent increase in studies on target for studies recruiting to plan, and a doubling of studies finishing on time. The company has put thought and money into making the output of its visualization aesthetically pleasing. It’s a beautiful program to watch, even if your trial is heading in the wrong direction.
It’s easy to get started. “It’s all about rapid deployment for us,” says Drumright. “It installs in less than a day.”
Drumright began her career as a programmer in Silicon Valley, eventually working at startups and larger companies. She initially started out at Decision View as a consultant, and realized that the company’s high-octane algorithms might really make a difference for customers. Drilling down to the study, country and site level allows visibility into where the recruitment is going well. And where it isn’t.
With the new version of the company’s software, the company has added more ability to automatically siphon data into StudyOptimizer from both electronic data capture (EDC) and clinical trial management (CTMS) systems. “We are completely agnostic as to the source,” Drumright says of the inputs to StudyOptimizer. “We want to make sure our customers can leverage the investments they made in their IT landscape.”
Drumright adds that the seasonality of clinical trials can be added to simulations and predictions. “Seasonality” could include both meteorological seasons and seasons for school, for marketing, or other pauses or heightened levels of activity. There is also what-if modeling allowing planners to add or subtract a site or a country to the mix—and see what the ramifications of that change are.
The new version also allows one individual to make global changes across a number of countries within a single study.d9A2t49mkex