Diabetes Mellitus, Type 2 — Randomized Trial of Health Events Costs in Diabetic Blacks
Citation(s)
Brancati FL, Appel LJ, Seidler AJ, Whelton PK Effect of potassium supplementation on blood pressure in African Americans on a low-potassium diet. A randomized, double-blind, placebo-controlled trial. Arch Intern Med. 1996 Jan 8;156(1):61-7.
Gary TL, Hill-Briggs F, Batts-Turner M, Brancati FL Translational research principles of an effectiveness trial for diabetes care in an urban African American population. Diabetes Educ. 2005 Nov-Dec;31(6):880-9.
Jackson CL, Bolen S, Brancati FL, Batts-Turner ML, Gary TL A systematic review of interactive computer-assisted technology in diabetes care. Interactive information technology in diabetes care. J Gen Intern Med. 2006 Feb;21(2):105-10. Epub 2005 Dec 22. R
Krop JS, Coresh J, Chambless LE, Shahar E, Watson RL, Szklo M, Brancati FL A community-based study of explanatory factors for the excess risk for early renal function decline in blacks vs whites with diabetes: the Atherosclerosis Risk in Communities study. Arch Intern Med. 1999 Aug 9-23;159(15):1777-83.
Shediac-Rizkallah MC, Bone LR Planning for the sustainability of community-based health programs: conceptual frameworks and future directions for research, practice and policy. Health Educ Res. 1998 Mar;13(1):87-108. Review.
Project Sugar 2: Health Events Costs in Diabetic Blacks
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.
