Cauley JA, Gutai JP, Kuller LH, Powell JG The relation of endogenous sex steroid hormone concentrations to serum lipid and lipoprotein levels in postmenopausal women. Am J Epidemiol. 1990 Nov;132(5):884-94.
Danielson ME, Cauley JA, Rohay JM Physical activity and its association with plasma lipids and lipoproteins in elderly women. Ann Epidemiol. 1993 Jul;3(4):351-7.
Vogt MT, Cauley JA, Kuller LH, Hulley SB Prevalence and correlates of lower extremity arterial disease in elderly women. Am J Epidemiol. 1993 Mar 1;137(5):559-68.
Vogt MT, Cauley JA, Kuller LH, Nevitt MC Bone mineral density and blood flow to the lower extremities: the study of osteoporotic fractures. J Bone Miner Res. 1997 Feb;12(2):283-9.
Vogt MT, Cauley JA, Kuller LH, Nevitt MC Functional status and mobility among elderly women with lower extremity arterial disease: the Study of Osteoporotic Fractures. J Am Geriatr Soc. 1994 Sep;42(9):923-9.
Vogt MT, Cauley JA, Kuller LH Apolipoprotein E phenotype, arterial disease, and mortality among older women: the study of osteoporotic fractures. Genet Epidemiol. 1997;14(2):147-56.
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.
