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August 13, 2002 | Bernard P. Wess Jr., president of Perseid Software Ltd., started working on clinical trials in academia in 1975, when statistical software called SAS was new. More recently, he completed a series of white papers for EMC Corp. on databases in the life sciences. He spoke with Bio·IT World's Mark D. Uehling about the larger context for the interplay between IT and clinical trials.

Q: What's your assessment of the pharmaceutical industry? Why is it slow to adopt better IT?

A: It is the least automated industry in the world. It is highly structured around rules and regulations, very conservative in changing behavior — for a good reason. No amateurs need apply. It's a highly credentialed industry. It's governed by intense, multidisciplinary regulation.

Q: How well has IT served the pharmaceutical industry?

A: If you go to the FDA Web site, you will see an endless stream of fines for failure to document computer software. The computer industry has been poor in quality control.

Q: Do mergers and alliances among drug companies affect IT?

A: All of the large firms desperately need partnerships. But that creates security, access, and control issues that are very complicated. The contract will determine the requirements for the information that can be shared with partners, suppliers, clinical trial experts, and the government.

The distribution of this information, independent of what HIPAA [the Health Insurance Portability and Accountability Act] will require, is extraordinarily complicated. I've heard the term 'selective transparency,' which is a wonderful phrase. What you really want to do is have your systems open up under certain conditions and let people get access to information — then close down. This is state-of-the-art stuff.

Q: But the industry is so tied to paper. How do you change that?

A: The problem is going to be trying to find the paper that didn't go into the computer. The pharmaceutical industry needs to go real-time. We need to acquire our patients through real-time interaction with physicians, and they should be signed up and inventoried in advance of need by physicians [and logged] into a database.

Q: Can those measures be implemented now?

A: I have not described anything that couldn't be built today. All of this is transaction processing, distributed over geographical areas, subject to relational database technology. [The data can be] kept without loss in available storage systems and accessed by query tools like SQL and SAS and DiscoveryLink.

Q: How should life science decision-makers approach these projects?

A: The architecture must support the business plan, not be technology for its own sake. Start at the top, have a simple strategy, try something small for a few million dollars. Demonstrate that it works, see how it affects people's behavior, and then roll it out institutionally as the strategy is defined as being successful. I don't believe in building $30-million systems upfront.

Back to Clinical Trial Data Management: Tortured by Paper 


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