Selection of Study Centers and Investigators

Site and investigator selection has traditionally been the result of a comprehensive process by which a study sponsor and/or designated representative, often a contract research organization (CRO), evaluates prospective investigative teams and associated clinical sites for clinical trial participation. A list of criteria is often compiled and used by the sponsor to grade site and investigator suitability for study participation. In implementing a study, sponsors and site teams become partners in achieving study goals. For longer-term or complex studies, this partnership can become extensive. Sponsors and site teams must mutually invest in respective stakeholder perspectives and approaches to answer research questions. Site teams interested in the research question, with sufficient and qualified staff, and with access to the desired participant population, are key to conducting sound research. Sponsors that appreciate site perspectives, consider site operations and logistics in protocol design, support efforts to mitigate site challenges, communicate updates on broader perspectives of study activities, and offer fair compensation for site resources are key factors in implementing a successful study. Conversely, disconnected relationships between investigative teams and study sponsors can disrupt the timetable for research, contributing to compromised morale, cost overruns, and increased variability in administrating the protocol resulting in reduced ability to detect treatment differences, and may result in an unsuccessful trial. A site and investigator selection process should be designed to ensure that both sponsors and site teams thoroughly evaluate whether the protocol design, resources, sponsor/team relationships, general timelines, and site facilities are compatible in achieving the goals of the study.