title: Multicenter clinical trials in sepsis: understanding the big picture and building a successful operation at your hospital.
abstract: Only through adequately designed and adequately conducted clinical trials can new treatments be found for the benefit of the septic patient. Over the past 20 years, tens of thousands of patients have been enrolled in sepsis clinical trials with little success. These efforts, however, have not been without worth. Much has been learned and the knowledge gained has changed our approach to trial design in this very difficult field. Animal studies are better designed to match the clinical picture of severe sepsis. Phase II studies are more carefully engineered to answer questions about the most suitable target population and end points. Trial conduct likely benefits from use of CROs and a CCC. The future of clinical trials may include more standardization of sepsis management across investigative sites. Before the decision is made to become an investigative site in a multicenter industry-sponsored clinical trial in sepsis or severe sepsis, it is important to recognize what is required to succeed. Once these key-to-success elements are in place, members of the investigative team are more likely to realize the satisfaction and career growth from becoming a successful site. The most professional satisfaction comes from the knowledge of contributing to original science in the field of the sepsis.
authors.affiliation: Robert Wood Johnson Medical School, University of Medicine and Dentistry of New Jersey, USA. dellinger-phil@cooperhealth.edu
authors.forename: R Phillip
authors.initials: RP
authors.lastname: Dellinger
authors.forename: Christa
authors.initials: C
authors.lastname: Schorr
authors.forename: Stephen
authors.initials: S
authors.lastname: Trzeciak
mesh_terms: D026661:Clinical Trials Data Monitoring Committees / Q000458:organization & administration*; D002986:Clinical Trials as Topic; D017321:Clinical Trials, Phase I as Topic; D017322:Clinical Trials, Phase II as Topic; D003284:Contract Services / Q000458:organization & administration*; D003299:Cooperative Behavior; D006739:Hospital Administration; D006801:Humans; D015337:Multicenter Studies as Topic; D012107:Research Design; D018805:Sepsis / Q000628:therapy*