Cardiac arrest research in humans--insights into failure.
Cardiac arrest research in humans has failed to fulfil expectations generated by laboratory studies. This reflects a number of factors. It is difficult to perform clinical research in the setting of emergency cardiac resuscitation. Both the epidemiology and pathophysiology of sudden death present special problems to the clinical researcher. Laboratory studies and clinical trials have failed to faithfully mimic each other. Estimation of sample size and application of inclusion/exclusion criteria present special problems in methodology. Our focus on improving long term survival by changing one component of therapy may have been premature and obscured the utility of extant data. Many of these problems can be addressed through refinements in: laboratory models, our understanding of the underlying pathophysiology, estimation of sample size, the application of inclusion/exclusion criteria, the identification of the primary dependent variables and subgroups of interest, the overall quality of therapy. Clinical studies will not generate useful data until these issues, among others, have been addressed.
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Department of Medicine, Columbia University College of Physicians and Surgeons, Columbia University, New York, NY, USA. aora@pipeline.com
D002986:Clinical Trials as Topic; D006323:Heart Arrest / Q000503:physiopathology / Q000628:therapy; D006801:Humans; D012106:Research; D015996:Survival Rate; D017211:Treatment Failure