Executives from both sides of the partnership met earlier this month at the Avoca Quality Consortium Summit in Princeton, NJ to discuss what could be done to enhance quality in outsourced clinical trials and how to make the partnerships more effective.
Stephen Cutler, PhD, group president of the CRO Icon, said CROs have a responsibility to “bring something new to a partnership...And we’re probably a little bit too passive, so in terms of evolving partnerships, I would encourage us to step up to bring solutions in different ways to improve the overall approach to drug development – different ways of developing drugs and risk-based monitoring. The CROs know the risks and opportunities well and we have a chance to step up.”
And pharma companies seem to agree, especially in terms of the creativity with which they are looking for CROs to approach partnerships.
Christopher Hilton, vice president of development & clinical alliance management at Pfizer, echoed Cutler’s comments, saying, “We hear it a lot that CROs really want to be much more involved in protocol design, decision making and selection of sites, and we’d be delighted…but you have to bring something to the table around that and build the infrastructure, and the support and the credibility to do those activities.
“I think passive is good word to use at the moment in terms of how often we see that. It’s all well and good to say I want to be involved in feasibility, for instance, but what a pharma company is used to is a really interactive dialogue that gives multiple scenarios, that looks at all possible options based on approval rates, timelines and costs associated,” Hilton added.
One Size Doesn’t Fit All
But other CRO executives seem to be reluctant to place the burden of passivity and responsibility so squarely on their own shoulders.
Jeffrey McMullen, PhD, vice chairman of the CRO inVentiv Health said he thinks it’s a joint responsibility between both partners. “I think clearly the CRO has an obligation to be able to articulate what it can bring to the table but I think the pharma company has an obligation to let them know that they are receptive to that kind of input. And often that’s not clear.
“CROs often go into these relationships with multiple clients and multiple personalities. It’s not an easy task to manage,” he added, conceding that it is the “obligation of a CRO to ask questions,” especially in terms of expectations on quality and feasibility.
Partnerships need to “start off focused and simple,” when often times a partnership will try to come up with a total solution from the outset, John Potthoff, president and CEO of Theorem Clinical Research added.
The size of the client can also be a major factor in how a CRO deals with a partnership.
Harris Koffer, PharmD, president of Research Pharmaceutical Services, said, “We’ve recognized that one size does not fit all” in terms of partnerships.
“For large pharma, biopharma and embedded partnerships, we’re working within the framework of their existing systems and then work over time to innovate around those – operating in a platform that’s consistent with how they operate,” Koffer said.
And for mid-sized biopharma and pharma companies, “we consult on a more strategic basis and say what pieces are missing from development from within,” whereas for smaller clients “we work on a more traditional, project-based approach,” he noted.