BMJ  2007;334:756-757 (14 April), doi:10.1136/bmj.39176.461227.80

Editorials

Composite and surrogate outcomes in randomised controlled trials

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

The first 150 words of the full text of this article appear below.

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 claims that . . . [Full text of this article]

Health Care Evaluation Group, University of Birmingham, Birmingham B15 2TT

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Rapid Responses:

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Composite resources and value freedom

Grazyna T Adamiak
bmj.com, 11 May 2007 [Full text]