Strategic relationships between drug developers and contract research organizations (CROs) are generating innovative approaches to clinical trial design and execution, but creating lasting value for both parties requires them to act in new ways, R&D executives from the pharmaceutical and biotech industry said at a gathering recently hosted by the Tufts Center for the Study of Drug Development.
“Despite the fact that a growing number of developers and CROs have now had three to five years of experience with these strategic relationships, speed and efficiency improvements and cost savings remain the exception,” said Ken Getz, associate professor and director of sponsored research at Tufts CSDD.
He added, “Old habits are slow to change and most drug developers are supporting practices that prevent them from integrating their strategic relationships and leveraging the value of these important collaborative models.”
Participants in the Executive Forum agreed that several factors, summarized in the October Tufts CSDD R&D Management Report, released today, can help strategic partners achieve higher levels of innovation but noted that it may take two or three years to begin to reap value from the partnership.
A recently completed Tufts CSDD study, based on extensive interviews across nine major pharmaceutical companies, found that
•Companies use a mix of outsourcing relationship models simultaneously on a per-study basis, including strategic and transactional relationships, along with in-house resources.
•Nearly all clinical studies outsourced site monitoring, and, in an overwhelming majority of studies, site identification and selection.
•In more than 70% of clinical studies, data management, medical monitoring, patient recruitment and retention, and statistical analyses were outsourced.
•For studies that were strategically outsourced, screen failure rates were higher and the frequency of protocol amendments was lower.
Roundtable participants noted that a jointly designed balanced scorecard, based on clearly defined metrics, used to monitor contributions and the new way both parties are working, helps provide continuous feedback to both parties, enabling them to adjust the way they operate and focus on the value gains both want to realize.
