No small change

Learning from failure

When companies make major changes in the way they do business, they sometimes hit a few bumps before arriving at a smooth patch of road. That's certainly been the case with Big Pharma, where, beginning in the 1980s, pharmaceutical companies tried without much success to implement electronic data capture systems. But now, Pfizer is one of a handful of industry players that are up and running with highly successful EDC systems. Analysts say Pfizer's I-Net is one of the most advanced EDC systems in the industry, with a deployed base of 4,000 users at more than 2,000 investigator sites in 36 countries.

But the change management hurdles were huge. Similar to the Chicago Police Department, internal and external users at Pfizer had to move to an online environment from the tried-and-true paper-based environment they'd been working in since the dawn of drug discovery. Clinical teams were very comfortable with paper case report forms (CRFs), on which patient data, such as demographics and vital signs, was collected and analyzed.

The collection and processing of trial data represents 40 percent of the cost of new drug development and is a gargantuan chunk of money, given that the average cost of developing a new drug is more than US$800 million. One of the obstacles Robert Goodwin, worldwide head of clinical data acquisition and management, and the business champion for Pfizer's I-Net system, faced was overcoming the fears of his R&D folks that the automation and standardization of CRFs would crush their creative abilities. For example, they feared that a standardized report form would hamper their flexibility to collect information while exploring new ways to do medicine. The company got their buy-in by asking for R&D's input on the electronic report forms. Ultimately, 80 percent of these forms became standard, leaving 20 percent to be unique to each study. The new forms also led to speedier trials. "We demonstrated that with standardization, we could start studies faster instead of making each CRF a Picasso," says Goodwin.

Getting internal therapeutic teams to pilot I-Net presented another knotty hurdle. "Everyone else wanted someone else to do it. They were excited about it as long as they weren't the ones piloting it," says Fly. Project leaders worked hard to give teams that volunteered an incentive. For example, the team studying estrogen receptors involved in breast cancer became motivated by the challenge of piloting I-Net and selling its benefits to clinical trial sites as well. Once word spread that the piloting teams were finding I-Net easy to use and reliable, other teams began to climb on board.

Wowing external users

In addition to its internal research teams, Pfizer needed the cooperation of most of its investigator sites -- the more than 2,000 locations in hospitals, private doctors' offices and universities where trials are run -- for I-Net to succeed. Doctors and nurses at these sites had the same concerns as Pfizer's internal users about moving from pen and paper to electronic CRFs. Not only did many medical professionals distrust computers, but they didn't have the time to deal with user-unfriendly technology. In fact, one of the biggest sources of user frustration with I-Net in the beginning was the long log-on script. "People didn't have the patience," says Fly.