Factors Influencing Investigative SIte Willingness and Ability to Participate in Clinical Trials

Title
Factors Influencing Investigative SIte Willingness and Ability to Participate in Clinical Trials

Abstract
The sponsor-site relationship is an essential consideration in investigative sites’ willingness to participate in clinical trials and sites’ ability to perform successfully. To better understand factors that impact this relationship, the Tufts Center for the Study of Drug Development, in conjunction with a working group of 10 pharmaceutical and biotechnology companies, developed a comprehensive two-part survey to examine clinical trial performance and investigator decisions to participate in a clinical study. Our respondents, clinical investigators worldwide, also provided company-specific ratings on training, investigator payments, receipt of supplies, study protocols, patient recruitment, and overall communication. A total of 3,516 surveys were completed for this study. The results indicate that having study information at the outset, sufficient numbers of eligible participants, adequate payments, and recruitment support are the factors that most impact site performance and willingness to participate. According to respondents, communication is a key issue to improving site operating efficiency. The results reveal how sponsors can help sites with challenges to operating efficiency, including patient recruitment, technology, communication, and financial operations.