Bell RL, Curb JD, Friedman LM, Payne GH Termination of clinical trials: the beta-blocker heart attack trial and the hypertension detection and follow-up program experience. Control Clin Trials. 1985 Jun;6(2):102-11.
Blaufox MD, Wassertheil-Smoller S Improving blood pressure normalization. Follow-up of hypertension screening and methodologies. N Y State J Med. 1979 Feb;79(2):231-5.
Borhani NO, Blaufox MD, Oberman A, Polk BF Incidence of coronary heart disease and left ventricular hypertrophy in the Hypertension Detection and Follow-up Program. Prog Cardiovasc Dis. 1986 Nov-Dec;29(3 Suppl 1):55-62.
Cressman MD, Gifford RW Jr Clinicians' interpretation of the results and implications of the Hypertension Detection and Follow-up Program. Prog Cardiovasc Dis. 1986 Nov-Dec;29(3 Suppl 1):89-97.
Daugherty SA Hypertension detection and follow-up program. Description of the enumerated and screened population. Hypertension. 1983 Nov-Dec;5(6 Pt 2):IV1-43.
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Davis BR, Langford HG, Blaufox MD, Curb JD, Polk BF, Shulman NB The association of postural changes in systolic blood pressure and mortality in persons with hypertension: the Hypertension Detection and Follow-up Program experience. Circulation. 1987 Feb;75(2):340-6.
Hypertension and Education Journal of the American Dietetic Association, 72 (4):377, April l978. (Summary of Mainstream Paper #5A.)
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Langford HG, Oberman A, Borhani NO, Entwisle G, Tung B Black-white comparison of indices of coronary heart disease and myocardial infarction in the stepped-care cohort of the Hypertension Detection and Follow-Up Program. Am Heart J. 1984 Sep;108(3 Pt 2):797-801.
Langford HG, Stamler J, Wassertheil-Smoller S, Prineas RJ All-cause mortality in the Hypertension Detection and Follow-up Program: findings for the whole cohort and for persons with less severe hypertension, with and without other traits related to risk of mortality. Prog Cardiovasc Dis. 1986 Nov-Dec;29(3 Suppl 1):29-54.
Shulman NB, Ford CE, Hall WD, Blaufox MD, Simon D, Langford HG, Schneider KA Prognostic value of serum creatinine and effect of treatment of hypertension on renal function. Results from the hypertension detection and follow-up program. The Hypertension Detection and Follow-up Program Cooperative Group. Hypertension. 1989 May;13(5 Suppl):I80-93.
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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.