Case studies

Largest ever clinical trial in diabetes – ADVANCE

11,140 patients, 20 countries, 216 centres, completed 2007

A factorial, randomised controlled trial study designed to determine the effects of intensive blood pressure lowering and glucose control on cardiovascular risks among type 2 diabetes patients. Covered both advanced economies in North America and Western Europe and emerging economies in Eastern Europe and Asia. ADVANCE had eighteen months for recruitment and an average of five years follow-up, and achieved a nine day database lock. Results have been published in The Lancet and The New England Journal of Medicine.

Largest ever clinical trial in critical care medicine – SAFE

6,997 patients, 2 countries, 16 centres, completed 2003

A randomised controlled double-blind study comparing the effects of saline versus albumin on mortality in 6,997 patients, with up to 30 days of follow-up. Completed under budget and ahead of schedule, with results published in The New England Journal of Medicine.

Largest ever clinical trial for secondary prevention of stroke – PROGRESS

6,105 patients, 10 countries, 172 centres, completed 2001

A randomised, double-blind trial examining the effects of an ACE inhibitor-based blood pressure lowering regimen on the risk of stroke among patients with a history of cerebrovascular disease. Results showed the treatment reduced risk of stroke by a quarter, and as a result such treatment is now recommended in international guidelines for treatment of hypertension, including the JNC7, WHO-ISH, European and Australian Guidelines, and in major guidelines for stroke management. Results have been published in The Lancet.