The interpretation of clinical trial data--wrongly ACCLAIM'ed?
Advances in medicine continue to drive forward through the practice of often impressive and innovative investigation. Through the application of randomized clinical trials, statistical analyses deliver the notorious "P values" to provide evidence of whether an intervention results in the desired clinical effect. However, it would appear that it is becoming increasingly common for trial reports to "cheat" the statistical system, particularly when lucrative industrial reward might be at stake. Fortunately, there is a safety net in place for the clinician who is less well accustomed to critiquing the research manuscript. In the United States, the Food and Drug Administration rigorously analyzes evidence relating to safety and efficacy of new therapies before approving them for general use. In Europe, the European Medicines Agency provides a similar service. Yet of much concern, there appears to be clear differences over the respective level of scrutiny of clinical trial data. This article discusses the unease of how a flawed international trial report appeared to deceive the European Union into approving a device-based product for chronic heart failure despite an important lack of credible data.
Shaw
Steven M
SM
Yonan
Nizar
N
Williams
Simon G
SG
Fildes
James E
JE
D018795:Device Approval; D023381:Endpoint Determination; D005060:Europe; D006333:Heart Failure / Q000276:immunology / Q000628:therapy*; D006801:Humans; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D014481:United States; D014486:United States Food and Drug Administration