The “broken” clinical trial business model discourages sites from investing in new tools and training to improve performance, says site expert Jeff Kingsley, DO, MBA, CPI, FACRP.
Sponsor “budgets are not [currently] incentivized for quality control,” notes Kingsley, chief executive officer of IACT Health and Chair of the 2017 Association Board of Trustees for the Association of Clinical Research Professionals (ACRP). That all must change, Kingsley stressed in a presentation at ExL Pharma’s recent Clinical Trials Financial Management Summit in Philadelphia, Pa.: “I want to see disruption in our industry.”
According to Kingsley, 60% of sites never reach the enrollment numbers they contractually promised to sponsors. “That would be unacceptable in other businesses,” he says.
Advancing certification in the clinical trial industry is one step in the right direction, says David Vulcano, LCSW, MBA, CIP, RAC, an AVP and the Responsible Executive for Clinical Research at Hospital Corporation of America in Nashville, Tenn., who also spoke at the Philadelphia event. An independent valuation shows principal investigators who hold the Certified Principal Investigator (CPI) designation are worth about a 10% increase in study budgets over the fair market value of those who are not, due to the evidence that they are producing “better quality trials and regulatory outcomes.”
Part of the problem, Vulcano warns, is that sites are too often viewed as commodities by sponsors. Instead, sites should be recognized—and incentivized—for making the effort to truly train personnel and producing quality work, Kingsley adds.
However, training deemed as “required” must match roles in a real-word way, Vulcano explains. It should be based on specific job tasks to promote true professional competency and not simply a checklist that “everyone is trained.”
Unfortunately, high-quality sites, meaning those that invest in training and technology tools, are often passed over on a bid because they are viewed as too expensive, Kingsley says.
Sites should also take a long, hard look at their processes, says ACRP Executive Director Jim Kremidas. There is plenty of evidence, he says, that suggests the current model is flawed here, too. For example, the Food and Drug Administration’s top clinical investigator inspections findings have remained virtually unchanged since 2013. “We’re making the same mistakes over and over again,” Kremidas says.
Author: Michael Causey