Novo Nordisk, Servier, Otsuka, Teva among top sponsors

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.

To read the full articles for this issue of The CenterWatch Monthly, please click here for subscription information.