Trial automation ripe for changing of the guard

Clinical trial automation technology appears destined to become a hopeless tangle of product types, with each slicing the pie into odd-sized and ill-fitting pieces: data capture, trial management, operations management, business analytics, resource allocation.

Perhaps a progression is happening here that will appear logical at some point. But continued updates and patches to legacy clinical trial architectures are putting both drug sponsors and investigators increasingly at odds with their critical need for trial process improvement.

The product-type tangle may be the result of clinical trial IT evolving through a logical progression of the drug development process when instead today it's a business progression that rules. If so, then the old standbys--EDC and CTMS, for example--may now be in the dreaded trough of disillusionment. That's what IT consultancy Gartner calls the period when user interest in a product technology wanes as implementations fail to live up to expectations.

"It's resource management we need to start thinking about [rather than trial management]," says Gartner research VP Steven Lefebure. His comments came during a phone interview regarding the Feb. 8 launch of the ClearTrial 4 trial operations software. He notes the solution helps close the loop of modeling to actual trial practice, including resource requirements.

Lefebure says the product's fundamental value proposition is its project benchmarking core, which transcends organizations. It can aid the many companies that have pink-slipped their institutional knowledge-holders. Coupled with simulation and activity-based costing capabilities, he says, the system can help sponsors trying to decide the dimensions of a trial. "As it gets traction, I expect other companies will notice," he says.

So the product doesn't fit into the usual categories of clinical trial automation. But maybe that's a good thing. It's direct in answering the need for trial process improvement, among the greatest challenges now facing drug developers. - George Miller