CARDIAC-ARREST RESEARCH IN HUMANS - INSIGHTS INTO FAILURE

Cardiac arrest research in humans has failed to fulfil expectations ge nerated by laboratory studies. This reflects a number of factors. It i s difficult to perform clinical research in the setting of emergency c ardiac resuscitation. Both the epidemiology and pathophysiology of sud den death present special problems to the clinical researcher. Laborat ory studies and clinical trials have failed to faithfully mimic each o ther. Estimation of sample size and application of inclusion/exclusion criteria present special problems in methodology. Our focus on improv ing long term survival by changing one component of therapy may have b een premature and obscured the utility of extant data. Many of these p roblems can be addressed through refinements in: laboratory models, ou r understanding of the underlying pathophysiology, estimation of sampl e size, the application of inclusion/exclusion criteria, the identific ation of the primary dependent variables and subgroups of interest, th e overall quality of therapy. Clinical studies will not generate usefu l data until these issues, among others, have been addressed.