Executives Raise Questions on Clinical Trial Sponsors’ Oversight of CROs

12-May-2013 - Last updated on 14-May-2013 at 15:53 GMT

Tension between clinical trial sponsors and CROs in terms of CRO oversight may not be relieved any time soon, but both sides seem intent on arriving at a middle ground where micromanagement stays low and the level of quality remains high.

Pharma and CRO executives at the Avoca Quality Consortium Summit in Princeton, NJ, on May 9 discussed ways in which both industries could create a cultural shift towards quality and risk-management, though nearly all participants noted the slow progress with which the industry moves in every aspect.

Avoca -- which brings together executives from CROs, pharmaceutical and biotech companies to discuss pressing issues -- said the results of its most recent survey of CROs and sponsors found that more than half of both sponsor and CRO respondents said they felt micromanaged. But only 41% of sponsors felt they could actually achieve quality trials without increased oversight.

Christopher Hilton, vice president of development and clinical alliance management at Pfizer, noted that his company has tried to remove as much redundancy with its CRO partnerships as possible, adding, “If we can move it towards a healthy tension, or a partnership, that might be better…but at the end of the day, CROs talk about wanting skin in the game and risk-sharing, but if we actually screw up at Pfizer and lose $2 billion, they aren’t going to share in that risk.” He added that CROs should be willing to give “a lit bit more in terms of transparency.”

And some say increases in risk sharing for CROs might not necessarily raise the level of trial quality. Mitchell Katz, executive director of medical research operations at Purdue Pharma, told Outsourcing-Pharma.com that quality does not necessarily improve when CROs have more of a financial stake in a trial’s outcome.

Some executives of CROs believe the uneven partnerships are levelling off, especially as IT investments have boosted the role and abilities of CROs. Some, such as Covance, have ramped up their IT investments over the past few years to try to separate themselves from competitors.

“If you’re a $30B pharma company and you have two clinical CROs that do all of your development, you better treat them like a partner,” Covance CEO Joe Herring said May 8 at the R.W. Baird 2013 Growth Stock Conference. And since it can take “a few years to wind down the backlog and wind up a new contract…partnership is not as much of a four-letter word as it was a few years ago,” he added.

Stephen Cutler, PhD, group president of Icon, said some of the additional, and at times unnecessary, oversight comes because sponsors have the upper hand in the relationship. "I think in the strong partnerships I've been involved in, the concept of a primary and secondary partner doesn't exist" and the "best sponsors demand CROs to speak up and it genuinely works well."

Anne Meeker-O’Connell, acting division director of good clinical compliance at the US FDA, seemed to take the middle ground, calling on both sides said, “We should focus on clarity, particularly when an issue is identified – so that it isn’t just identified and captured but also resolved.”

In addition to oversight, executives also said standards to deal with risk management and quality oversight, similar to the ICH’s Q9 for manufacturing, or FDA guidelines could help. “I think we’re desperate for [such a standard],” Jeffrey McMullen, vice chairman of inVentiv Health, said. Others called for a single platform for standard operating procedures, which could aid the sponsors’ call for transparency.

Michael Jones, senior director of Eli Lilly, bemoaned the lack of IT adoption that “could move us forward leaps and bounds in terms of real-time access.”