Cardiovascular Diseases — Observational Aspirin Use and CVD in the Physicians' Health Study
Citation(s)
Cook NR, Cole SR, Hennekens CH Use of a marginal structural model to determine the effect of aspirin on cardiovascular mortality in the Physicians' Health Study. Am J Epidemiol. 2002 Jun 1;155(11):1045-53.
Cook NR, Hebert PR, Manson JE, Buring JE, Hennekens CH Self-selected posttrial aspirin use and subsequent cardiovascular disease and mortality in the physicians' health study. Arch Intern Med. 2000 Apr 10;160(7):921-8.
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.
