Investigative Sites Continued to Shrink Over Last Five Years
The international landscape for investigative sites, research centres that conduct clinical research, has continued to decline over the past five years, according to US-based information services provider CenterWatch.
The global economic downturn is combining with decreasing study numbers, budget pressures, protocol complexity and regulatory burdens to turn experienced investigators off clinical research and destabilise the trial-site network, the new analysis reports.
The severest decline has been in the most active and proficient investigative sites that form the backbone of the clinical research industry in the US, while investigators based in Europe have shown the highest drop-out rates, CenterWatch adds.
For example, it notes, that the percentage of most active principal investigators (PIs), defined as those conducting at least two clinical studies a year, regulated by the US Food and Drug Administration has fallen from 29% to fewer than 23% during the past five years.
The average number of new trials started by the 60 highest-volume sites in the US and Canada have also dropped by 85% over the same period.
Difficult Operating Environment
“The global economic downturn and a 40% drop in clinical trials initiated since 2008 have certainly contributed to a difficult operating environment,” commented CenterWatch’s Editor-in-Chief, Cheryl Appel Rosenfeld.
“Complex protocols, flat study budgets, an onerous regulatory compliance burden and more intense competition for studies also have led some of the most active PIs to rethink their level of participation in clinical research,” Rosenfeld adds.
The CenterWatch analysis demonstrates that the global market for investigative sites market is becoming more fragmented, presenting new challenges for clinical research programme managers in government agencies, contract research organisations, and pharmaceutical and biotechnology companies.