Healthy — Study of the Response of Human Small Blood Vessels
Citation(s)
Falloon BJ, Heagerty AM In vitro perfusion studies of human resistance artery function in essential hypertension. Hypertension. 1994 Jul;24(1):16-23.
Furchgott RF Role of endothelium in responses of vascular smooth muscle. Circ Res. 1983 Nov;53(5):557-73. Review.
Goode GK, Heagerty AM In vitro responses of human peripheral small arteries in hypercholesterolemia and effects of therapy. Circulation. 1995 Jun 15;91(12):2898-903.
Study of the Relation Between In Vivo and In Vitro Response of Human Small Vessels
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.
