Clinical trial design in contemporary device studies in heart failure: is there a gold standard?
The assessment of the efficacy and safety of implantable cardiac devices used for the management of heart failure is complicated by procedural challenges. We present an overview of the advantages and disadvantages of different clinical trial designs, and discuss investigator and patient blinding. We conclude that blinding is optimal, but methodologically difficult. Until rules for and assessment of blinding are developed or surrogate measures are considered to be acceptable from a regulatory standpoint, an open-label design with objective end points is an unavoidable default standard.
Department of Medicine, Saint Louis University School of Medicine, St Louis, Missouri. Electronic address: hauptmpj@slu.edu.
Paul J
PJ
Hauptman
Division of Cardiology, University of Maryland School of Medicine, Baltimore, Maryland.
Stephen S
SS
Gottlieb
D002986:Clinical Trials as Topic / Q000592:standards*; D006333:Heart Failure / Q000601:surgery*; D006353:Heart-Assist Devices; D006801:Humans
Clinical trials; heart failure; implantable devices