title: Beyond randomized, controlled trials.
abstract: OBJECTIVE
  Most critical care physicians believe that randomized, controlled trials provide the best available evidence. This review contends that the importance of randomized, controlled trials was overemphasized and that they do not add more to knowledge and practice than physiologic and observational studies. In addition, protection of both patients and proxies may be less adequately ensured during randomized, controlled trials than during observational studies.
  
  
  RESULTS
  An analysis of the recent literature on critical care shows that conclusions from randomized, controlled trials are either disputable or do not affect existing practice. In addition, several papers reveal potential conflicts between randomized, controlled trials and ethical principles.
  
  
  CONCLUSIONS
  We may see in the future the twilight of randomized, controlled trials in critically ill patients because scientific, ethical, and sociologic substrata will be progressively lacking as will be funding.
authors.affiliation: Intensive Care Medicine Department, Hôpital Louis Mourier, Colombes (Assistance Publique-Hôpitaux de Paris), France. didier.dreyfuss@lmr.ap-hop-paris.fr
authors.forename: Didier
authors.initials: D
authors.lastname: Dreyfuss
mesh_terms: D002986:Clinical Trials as Topic / Q000941:ethics / Q000592:standards*; D003422:Critical Care; D016638:Critical Illness; D004992:Ethics, Medical; D005062:European Union; D006801:Humans; D007258:Informed Consent; D016032:Randomized Controlled Trials as Topic / Q000592:standards