Statistics Collaborative, Inc. (SCI) possesses long-standing experience in cardiovascular disease. At the time the company was founded in 1990, Drs. Wittes and Verter had over 30 years of combined experience designing, monitoring, analyzing, and reporting on cardiovascular clinical trials at the National, Heart, Lung, and Blood Institute (NHLBI) and The George Washington University. Since the founding of SCI, we have served as the independent statistical group on the Data Monitoring Committees (DMCs) for many industry-sponsored trials studying cardiovascular interventions. Participants include patients who are post–coronary artery bypass graft surgery (CABG) and at high risk of myocardial infarction (MI) and death; those with congestive heart failure (CHF); those with atrial fibrillation; and those at increased risk of stroke.
Examples of SCI’s work in cardiovascular disease:
- Cardiovascular safety: At the request of the National Cancer Institute (NCI), SCI performed statistical analysis that identified excess cardiovascular risk associated with celecoxib.
- Acute coronary syndrome: SCI provided statistical support to a small pharmaceutical company for the analysis of safety data from a trial of a novel anti-inflammatory.
- Heart failure: SCI has been involved in many trials in acute and chronic heart failure. We have served as the statistical center for the analyses of two large Phase 3 trials with clinical outcomes. We have collaborated with heads of the steering committees of four major clinical trials for heart failure so that the collective group could explore the natural history of heart disease. SCI served as the independent statistical group reporting to the Data Safety Monitoring Board (DSMB) for the Randomized Aldactone Evaluation Study (RALES) trial, which evaluated the use of spironolactone.
- Atrial fibrillation: SCI has prepared frequent DMC reports summarizing safety and efficacy data from a very large Phase 3 study (n=15,000) involving patients with atrial fibrillation and risk factors for stroke. One of the challenges for this study lies in presenting information on the concordance between the assessments by investigators and those by the clinical events committee concerning outcome events, such as bleeds, strokes, and MIs.
- Heart valves: Dr. Wittes is currently serving as a member of the International Organization for Standardization (ISO) committee on valve safety.
Some recent papers with which SCI was involved:
- Bavaria JE, Appoo JJ, Makaroun MS, Verter J, Yu Z, Mitchell RS. Endovascular stent grafting versus open surgical repair of descending thoracic aortic aneurysms in low-risk patients: a multicenter comparative trial. J Thorac Cardiovasc Surg 2007; 133:369-377.
- Tardif JC, McMurray JJ, Klug E, Small R, Schumi J, Choi J, Cooper J, Scott R, Lewis E, L'Allier PL, Pfeffer MA. Effects of succinobucol (AGI-1067) after an acute coronary syndrome: a randomised, double-blind, placebo-controlled trial. Lancet 2008; 371:1761-1768.
- Solomon SD, Wittes J, Finn PV, Fowler R, Viner J, Bertagnolli MM, Arber N, Levin B, Meinert CL, Martin B, Pater JL, Goss PE, Lance P, Obara S, Chew EY, Kim J, Arndt G, Hawk E. Cardiovascular risk of celecoxib in 6 randomized placebo-controlled trials: the cross trial safety analysis. Circulation 2008; 117:2104-2113.