Sepsis affects half a million people annually. Even though a large number of trials have been conducted, no therapeutic agent demonstrating clinical benefit or superiority to standard care has been identified. Designing clinical trials that have any probability of demonstrating efficacy is challenging, due to the heterogeneity of patient populations, poor understanding of the pathophysiology of acute sepsis, and lack of uniformly accepted standards of care in international trials. Intensive efforts have been undertaken by the Food and Drug Administration (FDA) to propose the optimal trial design and prospective analysis plans. Currently, an analysis of the failed sepsis trials is being initiated by the FDA with the hope of better clinical trials for the evaluation of the adjunctive therapy of sepsis in the future.
EXPECTED DATE OF COMPLETION:10/01/2001
AGENCY SPONSOR: Center for Biologics Evaluation and Research
FEDERAL CONTACT: Miles M. Braun, 301-827-3974
PIC ID: 6736
PERFORMER: Food and Drug Administration, Rockville MD