Global clinical trial performance and efficiency are hampered by high turnover and noncompliance among principal investigators and wide variation in investigative site experience, according to a recently completed assessment by the Tufts Center for the Study of Drug Development.
Although the highest turnover rates are observed among the least active investigators, turnover rates have been getting progressively worse among more active investigators. At the same time, protocol noncompliance, the most common performance deficiency and one that has grown the fastest during the past decade, accounted for 46% of all investigative site deficiencies, Tufts CSDD said.
“Operating conditions for clinical trials have noticeably worsened in recent years,” said Ken Getz, associate professor and director of sponsored research at Tufts CSDD. “Most frustrating for drug sponsors and contract research organizations looking to achieve higher levels of predictable performance is the wide variation that exists in the infrastructure, stability, and experience levels of investigative sites conducting clinical trials globally.”