Rob Musterer is director, clinical systems support at Bayer Healthcare. He is also head of a center of excellence dedicated to information systems for clinical R&D systems. Musterer has worked in the industry since 1981, and has watched several cycles of technology come and go. Like many people in the industry, he thinks pharma is taking too narrow a view of the clinical trial technology landscape.

In a nutshell, Musterer believes electronic data capture (EDC) has hogged the spotlight, at the expense of a diverse group of more pressing needs and capabilities.

He thinks the industry needs to begin to focus on “e-clinical” more than EDC. Says Musterer: “E-clinical is a change in mindset, to look across the entire clinical process, from protocol authoring through to submission. How do you best leverage the application of technology to increase efficiency and decrease cost throughout the life cycle of a clinical development project?”

He’ll be taking up a more expansive definition of “e-clinical” at the 2nd Annual eClinical Trials Congress, next week in King of Prussia, Penn. The agenda for the Center for Business Intelligence conference is here.

For starters, though, Musterer doesn’t think one solution will magically work for every company. It’s a question of understanding the technology needs of the entire organization, and analyzing which pieces are already present—and finding elements that are absent. “Companies have to map out their own strategy,” says Musterer. “What pieces do you already have? How are you going to put together the individual point solution to put together an e-clinical solution?”

He’s excited about service oriented architecture (SOA) to accomplish e-clinical tasks, even though he thinks the term is pretty similar to what “modular programming” meant in the past. “SOA holds a lot of promise for an e-clinical strategy,” he says.

Musterer believes that the providers of point solutions will have to do a better job of allowing their solutions to interoperate. Says Musterer: “They need to bring these into a cohesive, consolidated set of systems that talk to one another. The only way you’re going to do that is by having common metadata and define services so you can have these systems talk to each other.”

Connecting The Dots

One of the most valuable connections, he suggests, will be between EDC systems and drug safety applications, the contents of which must be painstakingly reconciled at the end of a trial. “There is always a fairly labor intensive process to reconcile what is in the clinical database vs. what is in the safety database,” he says. “You could minimize that overhead if everything was automated between those systems.”

Over time, Musterer says, it may be possible to force vendors to support both common database platforms and metadata backbone. That backbone of agreement on key terms and data structures, he readily admits, does not exist at Bayer or any other company.

The Era of Standards

But organizations like HL7 and the Clinical Data Standards Consortium (CDISC) have an unprecedented opportunity to nudge the industry toward more common terminology and approaches, he says. “There is more of a foundation on which this concept can build. It has a greater chance of success than it did five or six years ago.”

He says that managed care will put additional pressure on the industry. It is now obligatory, he says, to understand the real-world strengths of a drug or device so that it can be priced and positioned correctly. Data-mining will help, he suggests, with a special focus on health economics.

That topic would have received even more attention, he speculates, if the recent crop of drug safety issues had not been so prominent. “Health economics are going to rise again as a premier issue,” Musterer says.

Qualms About Vendors

He’s not happy with the vendor world, and says there are similar sentiments elsewhere on the sponsor side of the equation. At a time when some sponsors have washed their hands of software development, Musterer muses that some may try to get back into the game, just to do it right once and for all. Who better understands the needs of a sponsor than a sponsor? “Maybe it’s time to reconsider doing some of this stuff ourselves,” Musterer says. “We’re not getting what we need from vendors. I’m just starting to hear that. That reflects frustration with the immaturity of vendor solutions.”

Some vendors, needless to say, would hasten to point out that it has proven difficult for any organization (sponsor or vendor) to create a clinical application that is a) sufficiently fast and robust to please a single company or the industry at large and b) sufficiently customizable to serve companies with bulging libraries of standard operating procedures (SOP) detailing unique requirements for specific therapeutic areas, geographies and company divisions.