Implementing the EGASIS trial, an international multicenter acute intervention trial in stroke.
This paper describes some of the problems that were encountered during implementation of the Early GABA-ergic Activation Study In Stroke (EGASIS), a large international multicenter clinical trial evaluating the neuroprotective effect of diazepam in acute stroke. The focus is on obtaining funding for such a large international nonprofit trial, getting approval from all national and local ethics committees, shipping trial medication, and trial insurance. For each topic the specific problems and ways in which they were solved are described. Several recommendations for facilitating the running of a large international multicenter clinical trial such as EGASIS are made.
van Raak
Lisette
L
Department of Neurology, University Hospital Maastricht, P.O. Box 5800, NL-6202 AZ Maastricht, The Netherlands. evr@sneu.azm.nl
Hilton
Anne
A
Kessels
Fons
F
Lodder
Jan
J
D002986:Clinical Trials as Topic / Q000592:standards*; D026690:Ethics, Clinical; D006801:Humans; D007391:International Cooperation; D015337:Multicenter Studies as Topic / Q000592:standards*; D020521:Stroke / Q000628:therapy