Cardiovascular Diseases — International Programs Collaborative Studies Coordinating Center
Citation(s)
Broda G, Davis CE, Pajak A, Williams OD, Rywik SL, Baczynska E, Folsom AR, Szklo M Poland and United States Collaborative Study on Cardiovascular Epidemiology. A comparison of HDL cholesterol and its subfractions in populations covered by the United States Atherosclerosis Risk in Communities Study and the Pol-MONICA Project. Arterioscler Thromb Vasc Biol. 1996 Feb;16(2):339-49.
Rywik SL, Davis CE, Pajak A, Broda G, Folsom AR, Kawalec E, Williams OD Poland and U.S. collaborative study on cardiovascular epidemiology hypertension in the community: prevalence, awareness, treatment, and control of hypertension in the Pol-MONICA Project and the U.S. Atherosclerosis Risk in Communities Study. Ann Epidemiol. 1998 Jan;8(1):3-13.
Rywik SL, Manolio TA, Pajak A, Piotrowski W, Davis CE, Broda GB, Kawalec E Association of lipids and lipoprotein level with total mortality and mortality caused by cardiovascular and cancer diseases (Poland and United States collaborative study on cardiovascular epidemiology). Am J Cardiol. 1999 Sep 1;84(5):540-8.
Shestov DB, Deev AD, Klimov AN, Davis CE, Tyroler HA Increased risk of coronary heart disease death in men with low total and low-density lipoprotein cholesterol in the Russian Lipid Research Clinics Prevalence Follow-up Study. Circulation. 1993 Sep;88(3):846-53.
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.