Alternatives to mega-trials in cardiovascular disease.
This article considers the dominant role of trials involving thousands of patients--the mega-trials--in cardiovascular disease. Problems with large trials mean that alternative strategies must be developed to aid the introduction of new drugs. The limitations of meta-analysis, and of trials with combined and surrogate endpoints are discussed. Properly organized trials designed to establish whether or not two treatments have an equivalent effect seem to offer the best alternative to mega-trials.
Hampton
J R
JR
Department of Cardiovascular Medicine, University Hospital, Nottingham, UK.
D000319:Adrenergic beta-Antagonists / Q000627:therapeutic use; D002318:Cardiovascular Diseases / Q000188:drug therapy* / Q000401:mortality; D002986:Clinical Trials as Topic / Q000191:economics / Q000379:methods*; D006801:Humans; D015201:Meta-Analysis as Topic; D009203:Myocardial Infarction / Q000188:drug therapy; D012107:Research Design / Q000592:standards*; D013810:Therapeutic Equivalency
D000319:Adrenergic beta-Antagonists