It was our first visit to the annual meeting of the Society for Clinical Data Management. Last week’s conference was held in our favorite city on the planet: Chicago. Maybe we were just in a sunny mood because of that.

But we were still surprised by how rapidly the role of the data manager is evolving. It’s not just about getting the data and cleaning the data. It’s about adroitly running a clinical data assembly line.

Susan Krikorian, senior manager of data management at CV Therapeutics, may have had a similar thought. CV Therapeutics is a 500-employee small biotech based in northern California. Krikorian described a three-year, Phase III trial with 442 sites in 17 countries. There were half a million case report forms (CRFs) and 209,000 queries. Said a cheerful Krikorian: “I thought this study would never end.”

Know Your Role

Krikorian told the SCDM audience that the objectives of a contract research organization or technology vendor are certainly aligned with that of the sponsor, but not identical. “The goal of the partner is not necessarily the goal of the sponsor,” she said. “A CRO or data management partner is interested completing the study and following the quality. A sponsor is interested in submitting the study. It’s similar but it’s not quite the same.”

The key complication in her study was shepherding and coordinating data from more external partners than we could count. All of them were supporting the trial. That orchestra-conducting was complex, with 1,500 distinct issues to resolve even after the main CRO handling data management had set up its system. There were adverse event issues, data handling issues, you name it. Said Krikorian: “We had to collect the issues, we had to validate the issues, and review the issues with the CROs and coorodinate it. We had seven people working full time on just that.”

Communication Challenge

The company was realistic that key data elements would be cleaned, but that not all 70 million data points could be cleaned. “We all want to clean every piece of data,” Krikorian said. “But it’s not realistic in large Phase III studies.” In a major educational victory, she and her team were able to get external and internal organizations to see the value of clean data earlier in the process. That minimized delays at the end. “The whole team is interested in data quality prior to database lock,” she said.

One of the lessons, Krikorian says, is that better communication tools are needed. “We need to get better tools to automate the communications process. We had people working on spreadsheets forever. We are working on a more automated system.” There were no hints as to whether that is a commercial or a home-grown system.

Beastly Trial

Krikorian’s personal style was irreverent and refreshing. She clearly feels data managers will have to step up from being glorified nerds and into a much more administrative and strategic role in the modern clinical trial. By necessity, clinical operations and other colleagues will always be a part of such efforts, and Krikorian thanked her allies profusely from the podium.

But as trials become more elaborate, it appears that data managers are coming into their own. Said Krikorian: “Data management was seen as the preacher. Suddenly we were leading the choir and suddenly everyone was singing from the same hymnal. You have a choice. What is it you are going to be? It’s up to each and every one of you. The role of the data manager is moving off the traditional roles and into something else.”

In many ways, she sounded like a data quarterback. Our sports knowledge is a bit spotty. If memory serves, a quarterback has to hear a few cues from the sidelines and occasionally carry the ball. But at the end of the game, the job is about coordinating a team—and that is something that Krikorian and other data managers in the SCDM are learning to do quickly.