Picking the best clinical trial technology has always come with a price. The more technologies in the trial, the more difficult it is to link them. Some projects become so gnarly that sponsors defer or avoid using new, additional tools out of the sheer pain and fear over how to tie them into what they already have.
Now three of the industry’s top firms have developed a simplified way for customers to use their systems on the same trial. Almac Clinical Technologies, part of the Almac parent company, will manage the randomization and drug supply. PHT, a diary provider, will handle patient-reported outcomes. And Medidata Solutions will store the data inside its electronic data capture (EDC) system.
“Integration has been a huge problem for big pharma,” says Joe Bedford, director of marketing for Almac. “They have typically done a lot of that in-house. Trying to match their systems with more modern systems coming in has been difficult.”
As new functional power comes with the technologies for clinical trials, it can be frustrating to look at multiple systems and figure out what is happening with the trial. Basic questions like whether it is appropriate to send a monitor to a site can require data from multiple systems. Those systems may or may not be connected to each other.
“One of the things that is really important in this context is having data from various vendors all in one place,” says Bedford. “The big issue is, how do I get all these streams of data in one place at one time? The old way is to do it in house and have a huge data management department. It's very costly and a technical challenge.”
At next week’s annual Drug Information Association conference, in San Diego, visitors to the three firms’ booths will all pass data between each other, as if on a real trial. Almac will handle the randomization and collect patient demographic data. Then PHT’s systems will supply electronic patient-reported outcome (ePRO) data from patients. And everything will appear inside the Medidata EDC system. “What this allows [sponsors] to do is go to one place where their most important data is,” Bedford says.
The relationships with PHT and Medidata, Bedford notes, are nonexclusive. Meaning that any of the three firms may partner with other firms, as is routinely the case for all of them now. For specialized tasks, and users who prefer them, the PHT and Almac systems will still operate in their customary, validated manner. But one master copy of the data for cleaning and operational purposes will exist inside the Medidata system.
Bedford adds that splicing together various data streams is actually getting easier over time, not harder, and that that will allow the industry’s “best of breed” approach to technology to continue to be the dominant paradigm. “Companies with the best technology and process can seamlessly integrate data across their platforms,” he says. “The ease of integration is increasing. It's actually becoming easier to transfer data and integrate. The pain will be there. But it will be lessened and spread to outside firms.”
For all the usage of computers in other industries, and all the popularity of EDC, interactive voice response (IVR) and ePRO, Bedford estimates that perhaps 80 percent of trials still have a least one paper element. And in a bleak economic environment, almost all sponsor departments are still chopping away at data management staffing levels and internal IT resources. So the market for connecting the varied landscape of technologies is basically just getting started.
As integration becomes easier, he believes, it will allow more technology and service providers to flourish. Why? They will not be as likely to be locked out of participating in projects just because their systems cannot be easily connected to others. Contract research organizations (CROs) could be especially interested in the Almac-PHT-Medidata technology integration because it will start and lock trials faster than coming up with integrations on a custom-coded basis. Advance knowledge of drug supply shortages or surpluses can have big operational consequences; electronic systems allow proactive decisions to be made.
But the idea of easy clinical data integration is probably going to be controversial in some circles. Integrations involving two or three of the 10 largest names in the industry are relatively routine. The cost and complexity of joining perhaps a dozen different types of technology is also rekindling suite or unified systems in which one big program does everything, and there are no separate systems.
When operational data are accessible, Bedford notes, the sponsor community is increasingly using it during the middle of a trial, not just at the very end. In some cases, the approach is a bona fide adaptive biostatistical approach. In other instances, visibility into data just allows good business decisions, like shutting down Phase III trials after it is likely that the additional data will not be much different than what has already been gathered. “You could save tens of millions of dollars in some circumstances if you had data accessible at your fingertips,” Bedford says.d9A2t49mkex