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Plateaus and Point Solutions

Oracle’s Patti Gaves discusses EDC and integration.

By Ann Neuer

November 10, 2009
| In a recent conversation with industry veteran Patti Gaves of Oracle Health Sciences Global Business Unit, Bio•IT World was curious about her perspective on the current status of electronic data capture (EDC), the industry’s strong focus on integration of electronic point solutions, and the evolution toward eClinical trials. Gaves, senior director of Life Sciences Product Strategy, has more than 15 years of clinical data management experience and has worked in customer implementation and operations management.

Bio•IT World: Data suggest that approximately 50% of clinical trials are using EDC today. How has the market changed over the past decade?
: If you look at where we were ten years ago, when we were trying to sell the benefits and concepts, we are definitely in a mainstream situation. I hear objections to EDC less and less. I was with Oracle when we were introducing EDC, and back then, there were a lot of conversations about process adoption, and what you need to implement EDC trials successfully. When you talk to customers today, especially large ones who have been working with this for ten years or so, they are running about 80% of studies with EDC, and all new trials are running with EDC.

Going forward, what can we expect in the way of EDC adoption?
I see it starting to plateau in certain segments, such as some of the large customers, but there are those segments that are down in the continuum who have yet to come through the whole process. For some, such as academic medical centers, and small regional CROs, they are still coming along. In certain regions of the world, EDC is slow to take up due to some infrastructure problems in parts of Africa, Asia, and the Middle East. It’s still paper-bound there, but starting to evolve. Also, in the post-marketing surveillance world, there is still quite a bit of paper.

Do you see clients starting to think about eClinical trials and the integration of point solutions?
Absolutely—this is where we are headed. EDC is about having data sooner and doing something with it, but there is a need to leverage that technology with other solutions. The question is—can you access the data beyond the application in which it resides? The answer is often “no.” Oracle is working toward a fully integrated suite so accessing that data from any application will be possible. The cost of ownership around having best-in-breed in every application and trying to keep them hooked together and working is becoming insurmountable. The idea of moving to a more open, less proprietary approach, using Web services and services oriented architecture to facilitate your own product integration and out into the world is really a high priority right now.

What is Oracle’s approach to integration?
Oracle-wide, we have a strategy, and accompanying toolset to support integration called Application Integration Architecture (AIA). This approach incorporates standards-based technologies including XML, Web services, and Business Process Execution Language (BPEL). This allows customers to automate business processes across the enterprise using Web services. Oracle uses this methodology to package prebuilt integrations and maintain them across product releases. Customers and partners can also use the toolset to develop integrations independently. For health sciences specifically, applicable industry standards include CDISC, HL7, and BRIDG model.

Are most clients looking to integrate two solutions at a time, such as EDC with a clinical trial management system, or are they looking to integrate many point solutions at once?
We are seeing a lot of customers recognizing that, as they look across the enterprise, they need the same information, and they want to access it while minimizing redundancy.  They only want to define things once. This is one of our pain points—pieces of information being consumed downstream by upwards of fifty systems in big organizations. There is a big impact downstream in having the integration right. Historically, integration has been two solutions at a time because of the high maintenance cost associated with this, but that’s changing. The uptake is aggressive compared to the EDC timeframe. There will be a lot of movement toward integration and interoperability in the next five years, whereas it took about ten to adopt EDC.

What’s driving this rapid change?
It’s about an eClinical evolution. It’s happening very quickly because of the climate—economic and political. There are a lot of cost-containment and health care reform pressures that will put a lot of cost pressures on clinical development.

Any final comments?
There is a lot more technology outsourcing to CROs, which represents a shift in segmentation for us. The sponsors are less committed to the technology now because maintaining it is not their core competency. They have investments that they are preserving, but as we go forward, and depending on how their work is allocated—they may care less and less about whose product is being used. As a result, there will be more of a focus on CROs. 

This article also appeared in the November-December 2009 issue of Bio-IT World Magazine.
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