Bypass Angioplasty Revascularization Investigation 2 Diabetes Study Group Baseline characteristics of patients with diabetes and coronary artery disease enrolled in the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial. Am Heart J. 2008 Sep;156(3):528-536, 536.e1-5. doi: 10.1016/j.ahj.2008.05.015. Epub 2008 Jul 31.
Detre KM, Frye RL, Genuth S, guest editors A Symposium: Treatment of Coronary Artery Disease and Type 2 Diabetes: The Rationale for the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) Trial. American Journal of Cardiology 2006; 97(suppl 12A): 1G-65G.
Iskandrian AE, Heo J, Mehta D, Tauxe EL, Yester M, Hall MB, MacGregor JM Gated SPECT perfusion imaging for the simultaneous assessment of myocardial perfusion and ventricular function in the BARI 2D trial: an initial report from the Nuclear Core Laboratory. J Nucl Cardiol. 2006 Jan-Feb;13(1):83-90.
Magee MF, Isley WL; BARI 2D Trial Investigators Rationale, design, and methods for glycemic control in the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) Trial. Am J Cardiol. 2006 Jun 19;97(12A):20G-30G. Epub 2006 Apr 19.
McBane RD 2nd, Hardison RM, Sobel BE; BARI 2D Study Group Comparison of plasminogen activator inhibitor-1, tissue type plasminogen activator antigen, fibrinogen, and D-dimer levels in various age decades in patients with type 2 diabetes mellitus and stable coronary artery disease (from the BARI 2D trial). Am J Cardiol. 2010 Jan 1;105(1):17-24. doi: 10.1016/j.amjcard.2009.08.643. Epub 2009 Nov 14.
Pop-Busui R, Lu J, Lopes N, Jones TL; BARI 2D Investigators Prevalence of diabetic peripheral neuropathy and relation to glycemic control therapies at baseline in the BARI 2D cohort. J Peripher Nerv Syst. 2009 Mar;14(1):1-13. doi: 10.1111/j.1529-8027.2009.00200.x.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
