Hampton J R
Department of Cardiovascular Medicine, University Hospital, Nottingham, UK.
Cardiovasc Drugs Ther. 1997 Jan;10(6):759-65. doi: 10.1007/BF00053034.
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.
