Healthy Skepticism Library item: 9366

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Freemantle N, Calvert M
Composite and surrogate outcomes in randomised controlled trials
BMJ 2007 Apr 14; 334:(7597):756
http://www.bmj.com/cgi/content/full/334/7597/756

Abstract:

Composite end points may mislead-and regulators allow it to happen

In this week’s BMJ, Ferreira-González and colleagues report that clinical trials may mislead if they use composite end points.1 For example, a statement that an intervention reduces a composite end point of cardiovascular mortality, myocardial infarction, and revascularisation procedures is misleading if revascularisation procedures were more common outcomes than death or infarction, or if the intervention had a large apparent treatment effect on revascularisation but not on death or infarction.1 It is not enough for people who use the research-doctors and patients-to be aware of such potential to mislead: pharmaceutical regulators should also examine their role.

Pharmaceutical regulation has provided benefit to society by harnessing the innovation of industry towards improving health. Pharmaceutical regulation helps to ensure that drugs are safe and achieve clinically relevant benefits for patients. Regulation also governs the manner in which drugs may be marketed to prescribers and to patients. It allows only . . .