Early Trial Planning Solutions

By Allison Proffitt

June 21, 2010 | Medidata announced two new products at the Drug Information Association (DIA) meeting in Washington, D.C.: an updated version of Grants Manager and Medidata Balance.

Glen de Vries, Medidata Solutions president, says that Balance will do for clinical trial randomization what Medidata Rave did for data transfer from site to sponsor 11 years ago. “There’s never been somewhere where I can just go online and turn on a randomization system for a clinical trial,” says de Vries. “That’s exactly what we’ve done with Balance.”

Balance is a randomization and trial supply management (RTSM) solution that replaces interactive voice response (IVR) and interactive web response (IWR) systems. Study designers and trial managers can use Balance to plan and simulate trials, while sites can use Balance to assign subjects in real-time at enrollment, and begin drug supply planning immediately.

“Randomization can become quite complex,” de Vries told eCliniqua. “You’ll have a clinical trial where maybe you have 10 different doses or 5 different doses and you need to figure out which one is most effective. There may be other factors, the age of the subjects or their genders.” With traditional block randomization techniques, subjects are assigned in the trial according to a pre-determined schedule.

“You load that data into the system and when the inevitable issues occur, for instance a patients gets randomized then drops out of the clinical trial, you hope— you hope!—that you have balance in the trial, that you’ve achieved the relative equivalence of study subjects that have gotten the drug or placebo,” says de Vries.

The solution is dynamic randomization, or assigning subjects to the study based on how enrollment is progressing in real time while still remaining blinded and nondeterministic. “Dynamic randomization is something that has typically been regarded as the more advanced, the more complicated, the more expensive, the more time-intensive way to randomize subjects, and it’s therefore not used that much,” says de Vries. “We think dynamic randomization isn’t something that should require tons of cost and tons of time and tons of risk.”

In addition to one-click dynamic randomization, Balance supports trial simulations. “If you don’t like the way the trial came out if you did it ten times simulated, change the parameters and do it ten times more and see how it comes out,” de Vries says. “You can do all the design, and then just turn on dynamic randomization in a very streamlined way, without having to implement any custom software to do it.” 

Balance is not a module for Rave, but works seamlessly with the system. It brings all elements of the design and execution of randomization and supply logistics into the Medidata Rave platform. Giving trial designers and sites a single system for everything from randomization to EDC helps trials run with fewer subjects and less time, risk, and cost, says de Vries. 

How Much, and How Complicated
Continuing with a focus on early-trial planning, Medidata also announced an update to their Grants Manager product. Grants Manager 3.0 is where users aggregate and pool their worldwide grant payments and is a database of actual but anonymized trial costs.

“So you’re doing a new clinical trial. You decide you want to use some sites in China, but you want to know what, on average, a site in oncology in China in Phase II gets paid to do a blood draw. You use Grants Manager to figure that out,” explains de Vries.

Grants Manager 3.0 is now browser-based with a friendly user interface that provides data for more than 80 countries with specific regional groups by country and has the ability to assign different study arms for countries, regions and site budgets.

But the most exciting thing, de Vries says, is the benchmarking capabilities of not only cost but complexity, a measure based on research that Medidata did with the Tufts Center for Drug Development and that de Vries calls “spectacularly useful.”

“The benchmark that you get out of Grants Manager now shows you the information about complexity. Is your clinical trial one that is harder or easier from an execution standpoint for that site in China than they’re used to?... If I know that I have a particular clinical trial that is hard—meaning it’s going to take a lot of time and a lot of different procedures—I may want to go and find more experienced sites to work on it.” Having access to both complexity and actual cost data allows Grants Manager users to make operational decisions.