Manchester UK; Using just eight of its 14 hub sites Synexus recruited and randomised more than 2,740 of the 15,000 patients involved in AstraZeneca’s Crestor Jupiter study into cardiovascular disease. The study, which was stopped early, due to unequivocal evidence of a reduction in cardiovascular morbidity and mortality, was carried out in 1,200 sites across 26 countries. Each Synexus site averaged more than 314 patients.
Over 90% of late stage trials are still carried out by individual primary care physicians who recruit between five and ten patients each.
The Synexus model using full-time investigators at its hub sites dramatically reduces the cost of running clinical trials through having one negotiation and contract instead of hundreds and a handful of sites to monitor.
Synexus is planning to expand into the US and further grow its network of hub sites in Eastern Europe and India.
Synexus background
Synexus is the world’s largest multi-national company dedicated to the recruitment and running of late stage clinical trials. Synexus recruits for clinical trials on behalf of pharmaceutical, biotech and CROs. The clinical trials are then run and managed by Synexus at their own 14 hub sites across the world. Synexus pioneered the running of clinical trials at hub sites as against the traditional method of contracting with primary care physicians, who on average only recruit and manage five patients each.
Jupiter background
AstraZeneca stopped the CRESTOR JUPITER study early based on recommendations from an Independent Data Monitoring Board and the JUPITER Steering Committee, on March 29, 2008. The study will be stopped, as there is unequivocal evidence of a reduction in cardiovascular morbidity and mortality amongst patients who received CRESTOR when compared to placebo.
JUPITER (Justification for the Use of statins in Primary prevention: an Intervention Trial Evaluating Rosuvastatin) was designed to determine if treating patients with no evidence of pre-existing cardiovascular disease and low to normal LDL-C but elevated C-reactive protein (CRP) with CRESTOR 20mg once daily would reduce major cardiovascular events. CRP is a recognized marker of inflammation and is associated with an increased risk of atherosclerotic cardiovascular events.
The trial involved 15,000 participants at over 1,200 sites in 26 countries.
