Interview: Master of the EDC universe

Interview: Master of the EDC universe

Sylva Collins, promoted in July to global head of advanced clinical systems at Novartis, is the person who proved to the pharmaceutical industry that technology could be transformative in clinical trials.

Sylva Collins, promoted in July to global head of advanced clinical systems at Novartis, is not someone who invests in technology for its own sake. Collins buys technology to be more efficient. In the case of electronic data capture (EDC), she is the person who proved to the pharmaceutical industry that technology could be transformative in clinical trials. Collins has achieved benchmarks that are the envy of the industry. The percentage of Novartis' Phase I trials using EDC: nearly 60 percent. The percentage of Phase II and III trials using EDC: nearly 100 percent. Continents on which Novartis is running EDC-based trials: six. Investigative sites: more than 10,000. Nations using EDC: 50. Cost per page of data: US$4.60 versus $23 per page using paper. Contract employees dismissed: 70, out of a former total of 300 in data management.

The approach Collins has taken is not fancy or popular. She configures laptops dedicated to use open-source EDC software that has been heavily customized at Novartis. She's shipped more than 10,000 laptops all over the world. It's not at all clear whether the rest of the industry could or should emulate her approach. But it is clear that her results have set a standard that will be difficult for all of Novartis' competitors to match, much less surpass. She recently spoke to Bio-IT World's Mark D. Uehling.

Q: Some in the industry worry that clinical sites have rejected or are in the process of rejecting technology to capture clinical data electronically. What has been your experience at Novartis?

A: We have more than 700 investigators who have done two trials or more. 150 investigators have done three studies. In my experience at Bayer and Novartis, I think I have dealt with over 10,000 investigators and not lost a single one because of EDC. Once investigators get used to EDC, they do not want to go back to paper.

What does your cost figure of $4.60 per page of clinical data include?

It includes all cost centers that support EDC in data management. That includes the helpdesk, the laptops, data management, development of standards and processes, development of the software. That includes the costs of all activity, and including overhead. This is an 82-percent reduction in cost in data management. We also need fewer people -- significantly fewer people to do the work.

What was the most difficult part of nudging change forward at Novartis?

Internal resistance and turf battles. EDC is a radical change. It changes the way people do their jobs. It does not make anybody's job easier. It is just a different job for a smaller number of people -- different roles and responsibilities for thousands of people who are involved in clinical development.

EDC vendors often complain that software development is hardly a core competency in the pharmaceutical industry ... By bringing EDC software in-house you have full control of the enhancement, validation. My experience in the past, when we have tried vendor systems, is that they are expensive.

Vendor systems are going to cost you. You can't justify doing data management paying those licensing fees. The vendors have not been reliable, the ones that I have dealt with. This is not just for EDC -- for any software. And you cannot scale up with the expense we wanted to scale up with at Novartis.

You're saying the vendors couldn't scale their technology?

There is no one vendor that can support the aggressive scale-up that we wanted to conduct here at Novartis. The vendors we worked with, they basically told us, we can support maybe 10 trials per year. Or seven! One vendor wanted to do seven trials per year.

You've now done 330 studies using EDC. What's happened to your headcount?

In 2002, we had 300 people. But we were outsourcing 85 percent of the work. Now we have 245 people, and we are doing almost 100 percent of the trials in-house. Our pipeline is very rich. We are trying to support as many trials as we can with our system.

What is the most important lesson?

Perhaps the problem with the other companies is that they view EDC as a technology project. It is a radical change. It is not an IT project. That is the biggest pitfall that other companies are falling into. The key is to keep the EDC system, the software, simple. Just focus. Look at the big picture, not just technology. Technology is a small component of implementing EDC.

Why does the rest of the industry struggle with EDC?

The companies view EDC as a technology problem. There is always a better technology out there. It's true. There may be. You start using a system, and new management and a new executive comes and says, 'Well, I don't like the way you are doing it; let's try another system.' A new executive comes in and has preconceived notions on how he may have done it in the past. You need to focus on one system and make it work and focus on the bigger picture.

What metrics are you most proud of?

The speed of data review and time to database lock -- and quality of our databases. The quality of our databases is 93 percent better in terms of number of queries generated per 1,000 data points [compared to paper]. We lock our databases within a median time of four days. With paper, the median time was at least 10 weeks.

In your new role, you will examine the whole clinical process at Novartis, not just data management. What are the issues at every company?

People are pigeonholed in their own departments and protecting their own turf. Thinking small. They are chasing new technology for the sake of technology rather than focusing on useful processes and potentially useful technologies. We must be receptive to fundamentally new ways of achieving our objectives. You need competent leaders and managers who also understand the technical aspects of whatever they want to do.

How do people at Novartis feel about EDC now?

The resistance is almost gone. Now the resistance is if we ever decide to outsource a study because we can't handle it in-house. Once people get used to using EDC, they are over using paper. -- Bio-IT World

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