Caracciolo EA, Chaitman BR, Forman SA, Stone PH, Bourassa MG, Sopko G, Geller NL, Conti CR Diabetics with coronary disease have a prevalence of asymptomatic ischemia during exercise treadmill testing and ambulatory ischemia monitoring similar to that of nondiabetic patients. An ACIP database study. ACIP Investigators. Asymptomatic Cardiac Ischemia Pilot Investigators. Circulation. 1996 Jun 15;93(12):2097-105.
Davies RF The need for a prognosis trial of revascularization and aggressive medical therapy in patients with asymptomatic cardiac ischemia. ACIP Investigators. Asymptomatic Cardiac Ischemia Pilot. Clin Cardiol. 1998 Mar;21(3):154-6.
Deedwania PC Is there evidence in support of the ischemia suppression hypothesis? J Am Coll Cardiol. 1994 Jul;24(1):21-4.
McMahon RP, Proschan M, Geller NL, Stone PH, Sopko G Sample size calculation for clinical trials in which entry criteria and outcomes are counts of events. ACIP Investigators. Asymptomatic Cardiac Ischemia Pilot. Stat Med. 1994 Apr 30;13(8):859-70.
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.
