The worldwide economic downturn is combining with declining study numbers, budgetary pressures, protocol complexity and regulatory burdens to turn experienced investigators off clinical research and destabilise the trial-site network, a new analysis finds.
The global landscape for investigative sites has continued to shrink over the last five years, says US-based information services provider CenterWatch.
And the sharpest decline has been in the most active and experienced 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, the proportion of most active principal investigators (PIs) regulated by the US Food and Drug Administration – those conducting at least two clinical studies a year – has fallen from 29% to less than 23% during the past five years.
Moreover, the average number of new trials started by the 60 highest-volume sites in the US and Canada dropped by 85% over the same period.
Staying in business
With global contraction and a 40% decline in clinical trials initiated since 2008, experienced investigative sites with substantial clinical research infrastructure and high fixed costs are finding it difficult to stay in business, CenterWatch warns.
“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,” comments editor-in-chief Cheryl Appel Rosenfeld.
The CenterWatch analysis indicates that the global market for investigative sites market is becoming more fragmented, presenting new challenges for clinical research programme managers in government agencies, pharmaceutical and biotechnology companies, and contract research organisations.