Despite the premium that sponsors and CROs now place on driving higher levels of study conduct efficiency and performance,
the odds are greatly stacked against them given the structure and characteristics of today's global investigative site community.
Kenneth A. Getz
Recent research on the global study conduct service provider market paints a picture of a landscape that has been spinning
its wheels for 30 years, unable to mature or achieve scale efficiency and operating sophistication (e.g., standardized procedures,
financial and management controls). The site landscape has been in a perpetually nascent and fragmented state.
Stakeholders across the enterprise are looking to change the situation by focusing on a range of initiatives to transform
the study conduct landscape. Which approaches will achieve lasting and substantive improvement? A look at the current state
of the landscape and how it is managed may hold some insight.
Fragmented and independent
In 2013 the total number of active principal investigators (PIs) participating in FDA-regulated studies worldwide reached
its highest level in history. There are now nearly 28,000 unique investigators each conducting fewer trials on average than
in prior years. Annual growth in the number of active principal investigators between 2002 and 2012 has been modest (0.8%)
compared with rapid growth (9.7% CAGR) between 1992 and 2002.
Emerging regions, including Asia and Eastern Europe, have seen the highest relative growth in the number of FDA-regulated
investigators since the late 1990s due to the small bases from which they started. The proportion of investigators based in
North America has been declining steadily from 84% of the total international community of FDA-regulated investigators in
1998 down to 61% in 2012.
Less than a third of all investigative sites around the world are part of a network. The vast majority are stand-alone sites,
with limited infrastructure, operating autonomously. The typical investigative site has only one principal investigator and
two staff members involved either on a full or part-time basis as study coordinators.
For more than a decade, the United States was the only geographic area where independent investigators comprised the majority
of FDA-regulated sites. This is no longer the case as sponsors and CROs have looked to place more of their trials in emerging
regions. The majority (53%) of all FDA-regulated investigative sites operate as for-profit, independent, community-based entities
unaffiliated with academic systems. University, hospitals, and government clinics have been gradually losing their share of
industry-funded clinical trials. Two-thirds of all global FDA-regulated investigators in 2006 were based in academic settings
compared to 47% of the total in 2012.