Organizing a panel at a pharmaceutical industry event is not easy. There is little solid ground for true dialogue, as so many companies are doing the same activity in slightly different ways, with different terminology and procedures.
Another factor: as people rise in any hierarchy, growing into experts that meeting organizers would like to invite, they become more cautious about speaking freely. The solution? Say something politically correct and of no practical value, like a TV meteorologist bantering with the sports announcer after a commercial.
The planners of the 2010 annual Society for Clinical Data Management (SCDM) meeting, held last month in Minneapolis, skirted all that. They organized an all-star panel. Its members focused, like lasers, on one sentence: This body is resolved that within five years CDM activities will be conducted exclusively at service provider organizations and the CDM role as we know it will disappear in study sponsor organizations. Ouch.
Bam! That is a timely topic, even if it calls into question the need for the existence of the SCDM itself. The sentence was the point of departure for the most profound and substantive discussion your correspondent has heard in 8 or 9 years of listening to round table presentations in a variety of settings, at conferences large and small.
In part, the quality of the SCDM discussion could be traced to the candor of the participants and their long industry experience. The panel's fluidity and collegiality was enjoyable: the speakers appeared to be professionally acquainted and teased each other occasionally. They listened to each other, and did not merely stick to a script. Once or twice, most of them switched sides to argue the opposite position for a moment or two.
Gregg Dearhammer, president of i3 Statprobe tried to refute the view that data management will become extinct. “The statement is false,” Dearhammer said, rattling off a list of supposedly inevitable trends that never came to pass. “One hundred percent EDC? Integrated clinical and safety databases? Universal adoption of CDISC? I’ve been in the industry since 1993, and some of these were the things I worried about way back then.”
Eternal Status Quo
Dearhammer suggested the data manager role in sponsor organizations will change but persist. “The industry has never been known for moving fast, and never been known for moving in a unified manner,” he said.
He did not dispute the notion that some sponsors will outsource data managers. After all, he works for a company that takes on outsourced projects. But Dearhammer predicted most sponsors will retain data management expertise.
Susan Howard, a global compound lead at GSK agreed with Dearhammer, and with wily humor. One of her arguments was that overseeing a complex activity will require someone who is not a neophyte in that activity. “Pharma companies don’t have people to replace us,” she said. “There will always need to be that oversight to get on time, high-quality deliverables, especially for submissions.”
She had particular difficulty imagining how a CRO, with seemingly daily changes in personnel, would be able to confidently defend a data management plan. “They would not be able to speak to their data management at an FDA audit,” she said of outsourced personnel.
No one had a satisfactory reply to that, or to Howard's jest that statisticians may kid themselves that they are cleaning the data, but that real data managers know better. Yet even Howard conceded that CROs are doing more and more of the work, developing hard-to-find expertise. “We’ve been recruiting people from CROs. Who else has those skills?” she said, referring to project management skills.
The next member on the panel was Rob Goodwin. Part of his title is VP, operational excellence and business innovation at Pfizer. Our impression is that he has moved from a formal data management role into a safety position. Goodwin helped the big sponsor move 900 data management jobs to Armenia, Mexico and other locations around the world.
So it was not a shock that Goodwin believes the data managers will be moving out of non-sponsor firms. “Data managers as a position will not exist. But data management will exist. I want to clarify that,” he said. “I see the data management role evolving to be data brokers,” he said, perhaps tasked to get access to hospital data and other nontraditional sources of information from electronic health records (EHR).
Goodwin said new financial constraints on the life sciences would be relentlessly squeezing the R&D budgets of sponsor firms, with consequences for any non-core activity. A former era of abundance has ended. Said Goodwin: “That time has passed. We’re not getting as many drugs to market. Our margins are shrinking.”
At one time, he said, the industry could afford to spend lavishly on systems. Those days are gone. “The cost of systems is too much,” he said. “We can’t afford it any more. If we think we are going to have our own homegrown solutions, we’re wrong.” That was a strange comment in some respects, as Pfizer continues to use a partly homegrown, partly Oracle-based EDC solution.
In a tough-love vein, Goodwin said data managers should not take the change personally. Other key personnel in research (clinicians, statisticians, medical writers) are also being outsourced. But he did reluctantly concede Howard’s point about most CROs not having the right person to defend clinical data quality to a regulatory agency. “I agree, many people have moved on and will not understand what happened in that protocol,” Goodwin said.
Goodwin suspects, however, that other individuals inside the sponsor organization should be able to step up. Indeed, he implied, if you can’t do that, should you draw a paycheck? Said Goodwin: “Data is the responsibility of anyone on the clinical team. We all have responsibility for data.”
He then plunged bravely into some of most delicate and familiar territory of many SCDM conferences. He tackled the question of whether technology-oriented data managers had the assertiveness and human skills necessary to prove their worth to senior managers.
Goodwin was not shy about expressing his own view: more data managers should be vocal, and energetically so, when appropriate. “Do we continue to cower under the table and wonder why we’re not invited?” he asked. “The days of sitting behind your computer and being oblivious to everything going on around you are probably dead. You need people who can work with others. We have to start looking more strategically at where we want to be as a group.”
Goodwin said the key issue was the contribution of a data manager, not where he or she worked. “Many data managers are not up on what is happening with those regs,” he said. “When someone wants to be able to do something crazy on a trial, that's when you say, ‘here's why we can't do that.’ ”
Almost in the style of a labor organizer, Goodwin urged members of the audience to not bemoan their predicament. “Don't be passive," he said. "Don't go into the fetal position. Organize. Set a strategy and vision and move to that. Be advocates for change. Don't wait for it to happen.”
The final member of the panel was also named Howard, but no relation to Susan. Kit Howard, a veteran industry analyst and occasional contributor to this site, is the force behind Kestrel Consultants, and someone who has never been enamored with technologies or buzz words. For her, it’s all about the science and whether the collected data are supporting the science.
Like Goodwin, Howard sees the shift as inevitable, if one that will require a philosophical adjustment. “Pretty much every other industry has made this work,” she said. “Organizations continue to need to manage their costs, and the ups and downs of resourcing. It’s just a matter of time for us to get there.”
She was refreshingly clear and direct. “Data management in five years will look completely different from what it looks like today,” she said. “We will evolve more into a facilitator role.”
Providing a bit of career advice, she echoed Goodwin’s statement about not just staring at a computer screen all day. Howard said: “Be nosy. Get out there and learn everybody else's job.”
The silos in the industry are leading to miscommunication and unfortunate scenarios. “It is absolutely critical that we find a way to break down those walls and make those communications,” Howard said, so that each team knows what other groups need.
Howard was more candid than the other panelists about the adverse consequences of not getting the data management evolution right. She implied that the handoff to external organizations was possible but potentially more perilous than moving a shoe factory abroad. “We risk creating data that people go on to use inappropriately,” she warned. “It absolutely will come back to bite us.”d9A2t49mkex