Will Consolidation Transform Clinical Trial Landscape?

Mark Lacy, CEO of Benchmark Research and CEO of hyperCORE International

Mark Lacy, CEO of Benchmark Research and CEO of hyperCORE International

Increasing competition for a shallow, specialized patient pool is putting potentially terminal pressure on smaller clinical trial operations, some experts suggest. If that’s the future, a new entity plans to be ready.

hyperCORE International, a “super network” of clinical research site organizations unveiled in April, has just formed the second largest site network in the world with more than 80 sites across five countries on two continents. Its “unique ownership model combines the strengths of eight leading independent research site companies under one umbrella focusing on agility and innovation to accelerate clinical research through centralization of core operations and innovative strategic partnerships with Sponsors/CROs,” the company said in a press release.

“We’re getting ahead of the curve and trying to form a network that will compete with any kind of consolidated company or any other network that might pop up out there,” said Mark Lacy, CEO of Benchmark Research and CEO of hyperCORE.

“The consolidation of the industry means that organizations have to be more powerful in order to be able to get their share of the work, and it’s going to be much more difficult going forward for those standalone sites, particularly the small ones who don’t have the infrastructure to be able to compete in today’s market,” Lacy said, underlying part of the rationale behind the new entity.

Sometime during the next decade, Lacy predicted, the vast majority of physicians will be employees of a facility. Studies “show [virtually] 100% of all physicians will be employees by 2030 and that’s going to have a huge impact on the market because all of a sudden they’re not going to be able to participate in trials with other organizations” outside their own, Lacy added.

Ken Getz, chairman of CISCRP, a nonprofit organization that he founded to educate and raise public and patient awareness of the clinical research enterprise, “presented at ACRP 2018 talking about how research trials are becoming so difficult that we’re looking for these niche patient populations, rarer patients today than we ever did in the past,” noted Jeff Kingsley, CEO of IACT Health and COO of hyperCORE. As Kingsley saw it, Getz “presented his idea that research is going to shift back to academic medical centers and the small community organizations won’t be able to survive because their databases aren’t large enough. “His underlying premise is true, but I don’t [agree] with his end assumption,” Kingsley said.

“What we’re doing is creating a massive database with 15 million patients across our companies,” Kingsley said. “As we unite on a common technology program, a sponsor organization can show us a research proposal, and we can use our database to know where all the rare patients are, and say to the sponsor ‘we can fill your entire trial by placing a site right here in California, and this site’” in a different location.

The fledgling team just received evidence it’s off to a good start, winning the first ACRP All-Star Challenge for Sites challenge last month in Nashville. “I think it was extraordinary that we won the first year,” Lacy said. “Even though we don’t work for the same company, [the award shows] that we do have a common philosophy and can work together,” Lacy said.

During the ACRP All-Star Challenge for Sites, teams were asked to collaboratively solve problems presented in three real-world scenarios and to present to a panel of industry-leading judges. Scenarios were not provided in advance.

Author: Michael Causey