Multicenter clinical trials in sepsis: understanding the big picture and building a successful operation at your hospital.
The environment for clinical trials in sepsis has long been identified as challenging and full of road blocks and land mines. Unlike many other diagnoses (ie, cancer, acute myocardial infarction) relevance of animal studies and predictive capability of phase II trials for dose generation is less clear. The members of the investigative team must realize the essentials for success in a multicenter clinical trial. It is also useful and important to understand the big picture of clinical trial development as well as properly functioning interfaces among sponsor, contract research organizations, and investigative sites. Because early enrollment into sepsis clinical trials is usually required, collaboration between emergency medicine and critical care is needed.
Dellinger
R Phillip
RP
Robert Wood Johnson Medical School, University of Medicine and Dentistry of New Jersey, Division of Critical Care Medicine, Cooper University Hospital, Camden, NJ 08103, USA. dellinger-phil@cooperhealth.edu
Schorr
Christa
C
Trzeciak
Stephen
S
D000818:Animals; D026661:Clinical Trials Data Monitoring Committees; D002986:Clinical Trials as Topic; D017321:Clinical Trials, Phase I as Topic; D017322:Clinical Trials, Phase II as Topic; D003284:Contract Services; D006801:Humans; D015337:Multicenter Studies as Topic; D018579:Patient Selection