Piecing Together the Puzzle: Assembling a Successful Site-Sponsor-CRO Dynamic
SummaryAs more and more sponsors engage contract research organizations (CROs) at the discovery phase and the complexity of outsourced studies rises, the ability to manage the relationships between site, CRO and sponsor becomes more and more vital.
As more and more sponsors engage contract research organizations (CROs) at the discovery phase and the complexity of outsourced studies rises, the ability to manage the relationships between site, CRO and sponsor becomes more and more vital. The most obvious way to nurture that relationship is to establish clear communications guidelines from the start—well before study startup.
For example, effective collaboration between site and CRO can be jeopardized if the CRO challenges site practices instead of bringing queries or discrepancies to the sponsor first. While the CRO can and should be in direct contact with the site, the reality is that the site is accountable to the sponsor—not the CRO. Many times, the sponsor may have worked with the site, but not the CRO, meaning there are pre-existing methods and practices that the CRO may not be privy to, but that are perfectly acceptable to the sponsor and the site based on past experience.
As a result, the CRO should have the capacity to accommodate various working styles based on the preferences of the site, so long as the sponsor is comfortable with those approaches. If the CRO goes outside of traditional responsibilities and begins to query everything to the site without directing questions to the sponsor first, the risk is that time can be wasted and frustrations can mount—to the detriment of the relationship-building that is so vital to the creation of a successful site-sponsor-CRO dynamic.
Of course, as more and more sponsors partner with CROs at the discovery phase, it is less likely that there is a history to refer to between the site, sponsor and CRO. With a new indication, a new disease, a new product, a new company, the sponsor is often interacting with a site for the first time. While this can lead to a fresh approach to the process, it can also mean that there is less common ground from which to draw in the pursuit of successful clinical research. In the long term, the hope is that involving CROs earlier in the discovery process could enhance the ability to help anticipate—and navigate around—future failures, but that hope does not change the short-term obstacles that impact the development and management of a strong site-sponsor-CRO collaboration.
The task of building relationships and delineating responsibilities can be made even more difficult by the therapeutic area in which the three distinct groups are working. Cancer drug development, for example, has been deemed “perhaps the most arduous task faced by the drug industry today” by Josh P. Roberts of Genetic Engineering & Biotechnology News. Bringing together the site, sponsor and CRO in the face of such complex, time-intensive and costly studies can become an even larger challenge than anticipated. Add in escalating numbers of unique procedures per protocol, overworked sites, recruitment problems, site assessment issues, logistical concerns, cultural barriers and other potential variables, and it becomes easier to see why four out of every five trials is considered behind schedule, according to Roberts.
For these reasons and others, the most important step in establishing an effective triumvirate is ensuring that each of these groups is well aware of the lines of communication and how the three elements involved fit together. For example, if a clinical research associate has a conviction about what their role should be that does not match up with the sponsor’s understanding of the role, problems are certain to arise.
In many ways, establishing a cohesive, efficient collaboration between the site, sponsor and CRO involves putting all of the pieces together like a puzzle. Not only does every member of the group need to possess a keen understanding of their function within the dynamic, but they also need to have a firm understanding—and respect for—the role of both of the other members of the partnership.
Scott can be reached by e-mail at email@example.com or on Twitter (@Datatrial).
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