Cardiovascular Diseases — Reproduction and Survival After Cardiac Defect Repair
Citation(s)
Morris CD, Magilke D, Reller M Down's syndrome affects results of surgical correction of complete atrioventricular canal. Pediatr Cardiol. 1992 Apr;13(2):80-4.
Morris CD, Menashe VD 25-year mortality after surgical repair of congenital heart defect in childhood. A population-based cohort study. JAMA. 1991 Dec 25;266(24):3447-52.
Morris CD, Outcalt J, Menashe VD Hypoplastic left heart syndrome: natural history in a geographically defined population. Pediatrics. 1990 Jun;85(6):977-83.
Morris CD, Reller MD, Menashe VD Thirty-year incidence of infective endocarditis after surgery for congenital heart defect. JAMA. 1998 Feb 25;279(8):599-603.
Reller MD, Morris CD Is Down syndrome a risk factor for poor outcome after repair of congenital heart defects? J Pediatr. 1998 Apr;132(4):738-41.
Silka MJ, Hardy BG, Menashe VD, Morris CD A population-based prospective evaluation of risk of sudden cardiac death after operation for common congenital heart defects. J Am Coll Cardiol. 1998 Jul;32(1):245-51.
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.
