Green BB, Kaplan RC, Psaty BM How do minor changes in the definition of blood pressure control affect the reported success of hypertension treatment? Am J Manag Care. 2003 Mar;9(3):219-24.
Kaplan RC, Heckbert SR, Furberg CD, Psaty BM Predictors of subsequent coronary events, stroke, and death among survivors of first hospitalized myocardial infarction. J Clin Epidemiol. 2002 Jul;55(7):654-64.
Lahad A, Heckbert SR, Patrick DL, Psaty BM Hostility, aggression and the association with hypertension in post-menopausal women. J Hum Hypertens. 1996 Sep;10 Suppl 3:S115-21.
Lemaitre RN, Heckbert SR, Psaty BM, Siscovick DS Leisure-time physical activity and the risk of nonfatal myocardial infarction in postmenopausal women. Arch Intern Med. 1995 Nov 27;155(21):2302-8.
Psaty BM, Furberg CD Clinical implications of the World Health Organization-International Society of Hypertension statement on calcium antagonists. J Hypertens. 1997 Nov;15(11):1197-200.
Rhoads CS, Psaty BM, Olson JL, Furberg CD Medications and cardiovascular health in older adults: room for improvement in prevention and treatment. Am J Geriatr Cardiol. 2004 May-Jun;13(3):161-7. Review.
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.