Composite and surrogate outcomes in randomised controlled trials

doi:10.1136/bmj.39176.461227.80

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 allowit to happen

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

In this week's BMJ, Ferreira-González and colleaguesreport that clinical trials may mislead if they use compositeend points.¹ For example, a statement that an intervention reducesa composite end point of cardiovascular mortality, myocardialinfarction, and revascularisation procedures is misleading ifrevascularisation procedures were more common outcomes thandeath or infarction, or if the intervention had a large apparenttreatment effect on revascularisation but not on death or infarction.¹It is not enough for people who use the research—doctorsand patients—to be aware of such potential to mislead:pharmaceutical regulators should also examine their role.

Pharmaceutical regulation has provided benefit to society byharnessing the innovation of industry towards improving health.Pharmaceutical regulation helps to ensure that drugs are safeand achieve clinically relevant benefits for patients. Regulationalso governs the manner in which drugs may be marketed to prescribersand to patients. It allows only claims that . . . [Full text of this article]

Nick Freemantle, professor of clinical epidemiology and biostatistics, Mel Calvert, research fellow

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

N.Freemantle@bham.ac.uk

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