An analysis from the Tufts Center for the Study of Drug Development of 43 Phase II and III clinical studies found that, in each case, sponsors relied on a mix of transactional and strategic relationships, as well as in-house capabilities.
“Old habits, including the long-held view by sponsors that CROs are commodity service providers requiring substantial oversight, are slow to change,” according to the report.
Ken Getz, Director of Sponsored Research Programs & Research at Tufts CSDD, told Outsourcing-Pharma.com: “Sponsors are relying on a mix of approaches to hedge risk and to accommodate a variety of approaches simultaneously; many that were implemented years ago but that support legacy activity. The problem is that a mixed approach prevents sponsor companies from realizing the conceptual promise and value of integrated, strategic relationships.”
Interviews across nine major pharma companies by the center also found that sponsors will increase their use of external service providers in 2014 even though improvement in performance, quality, and cost has been elusive. This has been due largely to inconsistent sponsor management of external service providers, which has stymied integration of strategic outsourcing relationships.
Key takeaways from the study include:
- Nearly all clinical studies outsourced site monitoring, and for an overwhelming majority of studies, site identification and selection;
- Data management, medical monitoring, patient recruitment and retention, and statistical analyses were outsourced in more than 70% of trials;
- Internal sponsor staff most frequently manages protocol design and regulatory affairs;
- No sponsors used a single source to manage all outsourced functional areas; and
- For studies that were outsourced, screen failure rates were higher and the frequency of protocol amendments was lower.
Despite an overall reluctance to push to more strategic relationships, sponsors continue to refine relationship structures, modify internal team involvement and composition, and adjust the coordination, integration, and oversight of outsourced functions.
“We’re finding that organizations are not standing still – they’re very committed to seeing these relationships work and many are trying to refine the model; to identify areas where they can collaborate more effectively,” Getz told us.
Key issues, however, remain, including: how to engage with, and leverage, the right external partners; how to manage and motivate internal staff; and how to cooperatively manage the relationships.