Trial Start-Up Considerations: Budget, Staffing, Logistics

Clinical trials are research studies on human participants designed to evaluate a medical, surgical, or behavioral intervention. They are the primary way that researchers determine if a new treatment (e.g., surgical technique) is safe and effective for the patient [1]. There are two main types of studies: interventional and observational studies, depending on the exposure to a particular treatment, drug, or device. In interventional studies, perhaps better known as randomized controlled trials (RCTs), researchers assign interventions and study outcomes in a carefully planned and systematic way. Conversely, for observational studies, researcher simply observes what happens during the course of standard clinical care [2, 3]. Regardless of whether a study is interventional or observational, they may involve only one center (e.g., clinic, hospital) or more centers (multicenter study) in the same city or even in different countries [4].