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 May 9, 2003 | Forrester Research's senior healthcare analyst, Michael Barrett, is a highly regarded consultant on technology for clinical trials. Here, he shares some thoughts on electronic data capture with Mark Uehling.

Q: Some major companies claim all new trials are using EDC. Is this true? 
A: If the firms had reframed their announcements and said, 'The new default position is that we do EDC — unless circumstances indicate otherwise,' they would have been right on the money. That's what they're really doing. They're saying, 'It's EDC, unless ...' That's a helluva lot different than their saying, 'It's paper, unless ...' That's a huge change.

Q: So EDC is here to stay? 
A: Two-thirds of the top 12 companies are over the hump and have made the basic strategic decision to buy in. How they're going to implement it is another story. But make no mistake: The watershed moment has been reached.

Q: Why do you think large pharmaceutical companies are more innovative than small biotech companies?
A: Big Pharma has enough trials so that e-clinical solutions offer economies of scale. Big Pharma is leading the way in IT innovation. Small biotechs are just getting their toes into the water. They outsource trials because they have so few.

Q: How do contract research organizations fit into the story? 
A: They feel the most threat. They deploy the warm bodies into the field, visiting doctors' offices every six weeks on behalf of drug firms. They aren't quite sure when they want to [reduce] those staffs and go electronic. The CROs are bruised and gun-shy at the very moment that Big Pharma is finally interested in moving. The CROs are now meshing their [EDC] worldview nicely with their smaller customers and losing credibility with their larger customers.

Q: What do you make of the FDA trying to clarify or renounce IT-related aspects of 21 CFR Part 11? 
A: What we're seeing now are major public policy turnarounds focused explicitly on the FDA's not wishing to impede the adoption of technology in clinical trials. The FDA was persuaded by the parties it regulates that it had over-reached. You are seeing the ducks line up for the advance of clinical technology, whether it's clinical trials data capture or clinical care patient documents.

Q: Are the sponsors of clinical trials happy with the EDC vendor community? 
A: Now, finally, Big Pharma believes in the solution and in many cases decides that the homegrown alternative is the best. That's kind of weird. IT — building and running IT solutions — isn't normally a Big Pharma core competency.

Q: So drug companies believe they can find drugs and write code?! 
A: There are now power centers in these companies devoted to IT. These departments are fighting for their jobs. If they home-built a solution 10 years ago that's showing age, outsourcing it may not be appetizing. It may be threatening. The vendors have left themselves open to the [pharma] IT shops saying to their colleagues, 'Stick with us. We can do it.'


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