Sponsor relationship still largely hands off, especially with training: Everest survey.(CROs/sponsors)(Survey)

Just a little over half of clinical trial sponsors train their CRO personnel and 24% don't do any training at all, and investigator training remains a grey area of sponsor/CRO responsibility, a new survey of sponsors and CROs shows.

Todd Hintze, principal for life sciences at The Everest Group in Dallas, conducted a survey of 150 sponsors and 95 CROs in the spring to determine how relationships among drug firms and contractors are working out. Hintze revealed his findings at a Sept. 12 ExpertBriefings.com audioconference. Everest Group is a consulting firm that helps companies manage outsourcing.

When it came to training of clinical/medical leads and program and project managers, Hintze said 56% of sponsors provide on-the-job instruction, but 24% do not. In terms of managing the trials, he said, only 21% of sponsors train their CROs.

The survey did not address investigator training, which has become a concern in FDA BiMo audits, particularly in terms of protocol adherence and record keeping.

Hintze said this area is "contentious in terms of who pays, measuring the effectiveness and given what happens in the workplace as a whole. The risk and burden of those activities are some degree shared and pushed to the CRO, but the sponsor cannot abdicate that. In the end, the sponsor is trying to preserve a relationship with investigator sites and if they fail from a training or reimbursement matter, it creates friction."

The survey found that after years of experimentation, "sponsors are beginning to focus on a preferred CRO engagement model. Exclusive models are generally reserved for task outsourcing," Hintze said. He added that exclusive enterprise partnerships are "rarely formed" and that "full-service models are prevailing as the dominant approach."

"Sponsors are becoming more sophisticated in how they engage CROs and what model they pursue," Hintze added. But the "tipping point still eludes the CRO market as sponsors continue to up front and designed to minimize the risk. We see this in the financial services industry where they outsource."

When it comes to clinical trials, we put that on back end, he added.

Hintze's slides and complete survey results, as well as an audio of his talk, are available to BiCo subscribers for $225 plus handling. Visit www.ExpertBriefings.com or call (703) 779-8777.

By BioResearch Compliance Report Staff

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