Clinical Trials: Where is the Stopgap?

Right after Ken Getz turned in his column regarding the impact of consolidation among clinical research services, ICON announced its acquisition of the Mapi Group. In his article in our July/August issue, Getz outlined the recent acquisition activity of the five large CROs and overall dynamics at play.

For one, outsourcing penetration rates are noted at between 50% to 75%. But, as Getz says in his column, while the outsourcing continues to grow, there is no proof of effectiveness. For example, drug development

Lisa Henderson

speed, costs, or success of compound approvals are not improving. 

Meanwhile, sponsors continue to shed internal clinical operations in favor of CROs, and are in search of the best governance and oversight structures that don’t micromanage or duplicate roles. More sponsors are coming together in pre-competitive alliances to address inefficiencies in the process, such as TransCelerate’s Site Management and Training initiative, where members recognize their competitors’ training as sufficient for them. And while CROs insist they are innovators bringing efficiencies, apparently some industry stakeholders disagree. 

I stumbled across this opinion piece from a physician investigator, a critique of some CRO practices that are antithetical to efficiencies or innovation. And, even if the opinions are harsh, it wouldn’t be surprising to me to learn that large companies continue to engage in archaic practices without thinking through what they are actually requiring and just stick to the mantra: “It’s just the way things are done.”

Enter technology’s role. Technology is intended to improve data quality and make processes more efficient and people more productive. But after fits and starts of legacy software and painful upgrades, and the stitching of solutions toward a potential end-to-end clinical chain, cloud technology has entered clinical trials with seamless data sharing and collaborative capabilities. Oracle, the most recent entrant into the built-for-the-cloud platform, does so with its recently announced Clinical One-an investment of Oracle’s resources into engineering its applications to make trials faster. Steve Rosenberg, senior Vice President and General Manager, Oracle Health Sciences, said its unified system will take the costs out of clinical trials conduct. “Currently, tech is slowing things down, but Clinical One will reduce timelines.” 

But is it just tech slowing things down? Or large, bureaucratic CROs? Or regulatory authorities? Or even large sponsors, with M&As of their own and complex protocols? There’s no one out there saying, “How can we make trials longer, more difficult, more expensive, inefficient, and unsuccessful?” 

But we do have industry insiders who have lived the problem and reached out to developers to create a dream solution or process; or outsiders who look in and say, “How can this be? We can make it better.” Or even large companies like Oracle, who took its legacy infrastructure and said, “It’s time to invest and do this better.” There are a lot of good intentions out there, and eventually, maybe with new models and collaborations, trials will be paved with success and lower costs. 

Lisa Henderson is Editor-in-Chief of Applied Clinical Trials. She can be reached at lisa.henderson@ubm.com. Follow Lisa on Twitter: @trialsonline