Much has been written about the changing clinical research landscape, and more importantly, the implications these changes are having on small, independent research sites. The first major change was the implementation of preferred site programs by many larger contract research organizations (CROs). The second, and more recent development, is the actual acquisition of research sites and site networks by CROs. Separate of both of these trends, is the premise that “big data” will give larger health systems a competitive advantage, allowing them to reestablish their dominance in Phase II and III research. Each of these themes are explored in greater detail below.
Preferred Site Programs
Over the past few years, many of the larger CROs have established preferred site programs to strengthen their ties to their best performing sites -- defined as those that can recruit and deliver clean data. In reality, these preferred site programs simply formalize many of the relationships that study teams had with their higher performing sites. As such, the net impact on sites, both preferred and non-preferred, is minimal. Preferred sites continue to receive a disproportionate amount of quality study opportunities, while non-preferred sites fight for the remaining less desirable studies.
Unfortunately, much of the promise of preferred site programs has yet to be realized. Specifically, CROs have not been successful extracting efficiencies when working with their preferred sites, and benefits associated with being a preferred site are minimal. What once was once viewed as an exclusive club is in reality not all that exclusive, and the hope for more efficient study administration remains just that.
CRO Acquisitions of Sites
In the past several months, many of the largest CROs have announced acquisitions of small site networks. Many have suggested that this could be the start of a consolidation of independent sites and a significant reshaping of the site landscape. Most tenured sites remember the last time CROs went on an acquisition binge, acquiring several of the larger Phase I facilities. The net result of which was a reduction in the amount of study opportunities for independent Phase I facilities.
Fortunately, a number of macroeconomic forces should ensure that the impact from these recent acquisitions remains minor. First off, the prospect of a large scale consolidation seems remote given the limited opportunities to wring financial savings from synergies associated with a roll-up strategy. Secondly, the site business is transactional in nature, and the resulting variance in monthly revenues and profits does not mesh well with the quarterly financial reporting required by publicly traded CROs. Third and most important, the success of independent research sites is oftentimes linked to a key principal investigator or site director, and those individuals tend to be fiercely independent. It is hard to see many of those folks continuing with the CRO post-acquisition, therein eroding the motivation for the acquisition in the first place.
The Promise of Big Data
Large healthcare systems are just starting to reap the benefits of their Electronic Medical Record (EMR) implementations. It has been suggested that these systems will drive efficiencies in patient recruitment, allowing research coordinators to efficiently mine large patient databases for study participants. Further, it has been argued that this capability will provide larger health systems a competitive advantage over independent research sites. In reality, many smaller sites have been making commensurate investments in research patient databases and patient EMRs that will allow those organizations to remain competitive with larger health systems. Moreover, the factors leading to independent sites growing their share of the clinical research pie was tied more to their nimbleness and speed to market. While tracking patient information in a digital format will benefit some health systems, most continue to be slowed by layers of bureaucracy and a local Investigative Review Board (either in name or through a “research oversite committee”). Until these factors are addressed, the larger health systems will never regain the share of research they ceded to independent sites over the past two decades.
In summation, the independent site landscape will continue to evolve over the next several years, but it is doubtful that the existing trends will drive a meaningful change in the balance of power between independent sites, site networks, and large health systems.