Roundtable: Are We There Yet? How About Now? Now? - Pharmaceutical Executive

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Roundtable: Are We There Yet? How About Now? Now?
Can Electronic Data Capture become the industry standard for clinical trials? In this roundtable discussion, six early adopters reveal where they struggled, and what you need to know to implement this new technology.


Pharmaceutical Executive


CHIN: This is a business imperative to the pharmaceutical industry. We're under tremendous cost pressure, litigation, and safety, so it's not a matter of if we do it. It is a question of when we do it and how we do it. The time is here and it will take time, but people have to be able to get through this steep transition. There will be other issues to face, but it will be a little more clear sailing by then if we can enhance the user experience.

One thing to look at is the four pillars: people, process, technology, and support and services. Guess what? You can't work at them in series. You have to work with them concurrently. You have to balance all of these pieces and that's the challenge for an organization if you work on aggressive timelines.

BROWN STAFFORD: We need to see that EDC is not a data management position. It is mainstream, and it is enterprise wide. I still don't feel that, across the industry, there's complete buy-in, but it does impact the protocol design and clinical monitoring. I think it is also about clinical informatics in the end, and it is about patient data not just within a study, but a cross study. I don't know if it will end up being pharma companies doing that or not, but it will likely be a partnership between sponsors and CROs.

CHIN: In the next three to five years, I see us trying to truly manage the continuum from the time we do pre-clinical throughout the life cycle. The question will be: How do you leverage large databases, epidemiology, and genomics? We're all having issues in increasing patient recruitment, but with EDC, we should be able to tap into these large databases we've created. We have to be able to look at our safety and integrate it further upstream and wonder how to change things.

TIEDE: One of the things I observed is what I think the deployment of EDC is: It opened people's minds to looking at alternative ways of doing things. We've had some success and we started with this one area, and it's worked, but now, where else can we go? What else can we do? I think it's going to be related-type things branching out from there. That's the direction innovative work is going to take. The informatics and the large data warehouses are going to be really important.

We're in the process of conducting a trial in asthma, and we wanted to collect daily spirometry and diaries of patients, so we found a device that's a combination spirometry and diary. That's a whole new way of doing things now. I think there's so much going on, we're probably not even aware of. Now that we've deployed EDC, it says we can do other things since we've been able to demonstrate the success.

To me, EDC is not a panacea. It is not going to solve everything. Early on people felt we were going to save millions and millions of dollars by cutting out so much time. EDC is a cost-effective tool, but it is not going to cut months out of our development time. Recruitment will still be an issue. But there are still huge significant values that EDC brings in terms of the way we work, the efficiencies that we can gain, accessibility, and so on. We also have to keep expectations realistic in terms of what this tool can and will do for us, and what it can't do for us.

TYSON: This really represents a very sort of interesting inflection point for clinical organizations because it's this whole idea that the way we used to do things is mutable, it's changeable. There is new technology and we need to start thinking about what we do, not in terms of our jobs, but in terms of what the ultimate end goal is to get this data. This legacy being left behind by EDC is this concept and this experience set of all these terrific people understanding the common embrace of technology and using it to gain benefits. It's next generational thinking.


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