Fornage M, Amos CI, Kardia S, Sing CF, Turner ST, Boerwinkle E Variation in the region of the angiotensin-converting enzyme gene influences interindividual differences in blood pressure levels in young white males. Circulation. 1998 May 12;97(18):1773-9.
Hallman DM, Ellsworth DL, Boerwinkle E Molecular and genetic approaches to the study of cardiovascular disease. J Cardiovasc Risk. 1997 Oct-Dec;4(5-6):325-31. Review.
Hallman DM, Srinivasan SR, Chen W, Boerwinkle E, Berenson GS The beta(2)-adrenergic receptor Arg16-gly polymorphism and interactions involving beta(2)- and beta(3)-adrenergic receptor polymorphisms are associated with variations in longitudinal serum lipid profiles: the Bogalusa Heart Study. Metabolism. 2004 Sep;53(9):1184-91.
Hinojos CA, Boerwinkle E, Fornage M, Doris PA Combined genealogical, mapping, and expression approaches to identify spontaneously hypertensive rat hypertension candidate genes. Hypertension. 2005 Apr;45(4):698-704. Epub 2005 Feb 14.
Klos KL, Hamon S, Clark AG, Boerwinkle E, Liu K, Sing CF APOA5 polymorphisms influence plasma triglycerides in young, healthy African Americans and whites of the CARDIA Study. J Lipid Res. 2005 Mar;46(3):564-71. Epub 2004 Dec 16.
Klos KL, Kardia SL, Ferrell RE, Turner ST, Boerwinkle E, Sing CF Genome-wide linkage analysis reveals evidence of multiple regions that influence variation in plasma lipid and apolipoprotein levels associated with risk of coronary heart disease. Arterioscler Thromb Vasc Biol. 2001 Jun;21(6):971-8.
Krushkal J, Xiong M, Ferrell R, Sing CF, Turner ST, Boerwinkle E Linkage and association of adrenergic and dopamine receptor genes in the distal portion of the long arm of chromosome 5 with systolic blood pressure variation. Hum Mol Genet. 1998 Sep;7(9):1379-83.
Page GP, Amos CI, Boerwinkle E The quantitative LOD score: test statistic and sample size for exclusion and linkage of quantitative traits in human sibships. Am J Hum Genet. 1998 Apr;62(4):962-8.
Turner ST, Boerwinkle E, Sing CF Context-dependent associations of the ACE I/D polymorphism with blood pressure. Hypertension. 1999 Oct;34(4 Pt 2):773-8.
Turner ST, Boerwinkle E Genetics of hypertension, target-organ complications, and response to therapy. Circulation. 2000 Nov 14;102(20 Suppl 4):IV40-5. Review.
Xiong MM, Krushkal J, Boerwinkle E TDT statistics for mapping quantitative trait loci. Ann Hum Genet. 1998 Sep;62(Pt 5):431-52. Erratum in: Ann Hum Genet 1999 Sep;63(Pt 5):469.
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.