Strategic CRO relationships no more effective than traditional models, Tufts

By Dan Stanton

- Last updated on GMT

photo - iStock pichet_w
photo - iStock pichet_w

Related tags: Clinical trial, Ucb

Inconsistent practices and a lack of trust are restricting sponsors from fully realising the potential of CRO strategic partnerships, according to Tufts' Director Kenneth Getz.

In the past few years, many pharma firms have shifted their outsourcing model away from commodity-type service agreements to strategic, long-term partnerships.

Speaking at last week’s PCT meeting in Hamburg, Germany, Kenneth Getz, Director of the Sponsored Research Program at Tufts Center for the Study of Drug Development, said currently 96% of major pharma firms are now involved in at least one integrated alliance, compared to 63% in 2008.

“While there is no indication that this level of penetration will abate or decline,”​ he said, a recent Tuft’s study shows evidence that poor utilisation and a lack of trust is making these types of relationships no more effective than traditional CRO use.

“We looked at a collection of Phase II and Phase III studies among all companies who had entered into at least one integrated or strategic relationship, and what we found was that in no case was the CRO partner being used in the way that was intended,”​ he told delegates.

“Instead we saw organisations were mixing and matching approaches depending on the preferences of the clinical team [resulting] in widely inconsistent behaviour within companies in terms of when and how they would use an integrated partner.”

There was significant difference found in the number of screen failure rates, and number of protocol amendments, both in favour of strategic alliances, but across 13 other performance variables “there was virtually no statistically significant areas of impact on performance between those projects and studies managed under an integrated relationship versus those which had more of a transactional approach.”

Trust and collaboration

Getz attributed this lack of CRO leverage down to practical issues with sponsors attempting to juggle various CROs under through different outsourcing models, while an ingrained culture among some sponsors has attributed to a distrust of CROs and reluctance to view them as anything more than a commodity service.

While 68% of sponsors report that they’re not getting enough innovative ideas from CROs, he said on the other side of the coin 46% of CROs believe that sponsors are not open to innovative ideas proposed by them.

Furthermore, citing 2015 reports from Tufts, Avoca and Centerwatch, only 14% of 93 surveyed CROs said they had opportunities to regularly participate in development planning and protocol design.

UCB case study

Also speaking at the conference was Diane Driver, Global Head of Outsourcing and Strategic Partnering at UCB. Like other pharma firms, UCB moved to an integrated alliance model earlier this decade, selecting Parexel and PRA as its two strategic partners.

But following an internal review in September 2014, she explained the move had not produced the outsourcing efficiencies that had originally been envisioned, blaming a lack of trust and transparency within its own organisation.

“There were problems with communications,”​ she said. “UCB didn’t know how to step back.”

However, since then the firm has implemented a number of changes, including bringing in ‘embedded partner liaisons’ - senior level managers from PRA and Parexel to sit in at UCB – which help harmonise SOPs and communications between the sponsor and its CRO partners.

Driver said this has led to a better understanding of its CROs’ processes, structures, and cultures, and a change in perception of them from contractors to partners.

Correction - the original article stated UCB's strategic partners to be Parexel and PPD. This has been changed to reflect that UCB's partners are actually Parexel and PRA.

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