Clinical trials in the wake of Vioxx: requiring statistically extreme evidence of benefit to ensure the safety of new drugs

Circulation. 2006 May 9;113(18):2253-9. doi: 10.1161/CIRCULATIONAHA.105.604512.

Author

Michelle D Roth-Cline¹

Affiliation

¹ Department of Statistics, University of Wisconsin, Madison, WI 53792, USA. mdrothcline@wisc.edu

PMID: 16684875
DOI: 10.1161/CIRCULATIONAHA.105.604512

No abstract available

MeSH terms

Anti-Inflammatory Agents, Non-Steroidal / adverse effects*
Clinical Trials as Topic / legislation & jurisprudence
Clinical Trials as Topic / methods
Clinical Trials as Topic / standards
Clinical Trials as Topic / statistics & numerical data*
Cyclooxygenase 2 Inhibitors / adverse effects*
Drug Approval / legislation & jurisprudence
Drug Approval / methods*
Drug Approval / statistics & numerical data
Drug and Narcotic Control* / legislation & jurisprudence
Health Policy*
Humans
Hydroxymethylglutaryl-CoA Reductase Inhibitors / adverse effects
Lactones / adverse effects*
Myocardial Infarction / chemically induced*
Myocardial Infarction / epidemiology
Probability
Product Surveillance, Postmarketing
Pyridines / adverse effects
Research Design
Rhabdomyolysis / chemically induced
Risk Assessment
Stroke / chemically induced*
Stroke / epidemiology
Sulfones / adverse effects*
Treatment Outcome
United States
United States Food and Drug Administration

Substances

Anti-Inflammatory Agents, Non-Steroidal
Cyclooxygenase 2 Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Lactones
Pyridines
Sulfones
rofecoxib
cerivastatin