Sponsors have done a good job of maintaining, but not improving, the overall quality of their relationships with investigative sites during the past two years, according to a new CenterWatch survey, but performance gaps have widened across several of the attributes sites identify as the most important for conducting a successful study. Leading sponsor companies have made strengthening their relationships with investigative sites a top priority in recent years and have created a wide range of initiatives designed to incorporate investigator viewpoints into improving clinical development processes and easing site burdens. The 2017 CenterWatch Global Investigative Site Survey suggests that investigators have raised their expectations for sponsor performance in providing better study support, good protocol design and easily accessible staff as investigators face increasing compliance, regulatory and financial pressures when conducting clinical trials.
Sites wrestle with protocol design complexity
The growing complexity of protocols is resulting in longer cycle times, rising costs and increased pressures on staff and patients throughout the clinical trial process. Tufts Center for the Study of Drug Development (CSDD) studies have found that the number of endpoints, procedures and eligibility criteria of typical phase III protocols increased significantly during 2002-2012, and have continued to grow. These factors combine to increase costs and burdens on research teams.
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