title: Do current clinical trials meet society's needs?: a critical review of recent evidence.
abstract: This paper describes some important controversies regarding the current state of clinical trials research in cardiology. Topics covered include the inadequacy of trial research on medical devices, problems with industry-sponsored trials, the lack of head-to-head trials of new effective treatments, the need for wiser handling of drug safety issues, the credibility (or lack thereof) of trial reports in medical journals, problems with globalization of trials, the role of personalized (stratified) medicine in trials, the need for new trials of old drugs, the need for trials of treatment withdrawal, the importance of pragmatic trials of treatment strategies, and the limitations of observational comparative effectiveness studies. All issues are illustrated by recent topical trials in cardiology. Overall, we explore the extent to which clinical trials, as currently practiced, are successful in meeting society's expectations.
authors.affiliation: Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, United Kingdom. Electronic address: stuart.pocock@lshtm.ac.uk.
authors.forename: Stuart J
authors.initials: SJ
authors.lastname: Pocock
authors.affiliation: Department of Cardiovascular Diseases, Mayo Clinic College of Medicine, Rochester, Minnesota.
authors.forename: Bernard J
authors.initials: BJ
authors.lastname: Gersh
mesh_terms: D002309:Cardiology / Q000379:methods*; D002318:Cardiovascular Diseases / Q000628:therapy*; D002986:Clinical Trials as Topic / Q000592:standards*; D019983:Guideline Adherence; D006801:Humans; D011634:Public Health; D012955:Societies, Medical
keywords: clinical trial; placebo effect; public health; random allocation; reporting; research design; statistical analysis