Clinical trials of lipid-modifying agents: design considerations

Clinical trials are a powerful tool for changing clinical practice and, in the field of lipid modification, have had a major impact on the quality of clinical care. In order to demonstrate the modest, yet worthwhile, effects on cardiovascular outcomes achieved by lipid modification, such trials may need to be on a large-scale and of long duration, and in recent years have become increasingly expensive and complex to undertake. However, careful planning in the design and conduct of such studies will increase the chance of informative conclusions and minimize both cost and complexity.