Alaupovic P, Mack WJ, Knight-Gibson C, Hodis HN The role of triglyceride-rich lipoprotein families in the progression of atherosclerotic lesions as determined by sequential coronary angiography from a controlled clinical trial. Arterioscler Thromb Vasc Biol. 1997 Apr;17(4):715-22.
Hodis HN, Mack WJ Triglyceride-rich lipoproteins and the progression of coronary artery disease. Curr Opin Lipidol. 1995 Aug;6(4):209-14. Review.
Hodis HN Reversibility of atherosclerosis--evolving perspectives from two arterial imaging clinical trials: the cholesterol lowering atherosclerosis regression study and the monitored atherosclerosis regression study. J Cardiovasc Pharmacol. 1995;25 Suppl 4:S25-31.
Mack WJ, Azen SP, Dunn M, Hodis HN A comparison of quantitative computerized and human panel coronary endpoint measures: implications for the design of angiographic trials. Control Clin Trials. 1997 Apr;18(2):168-79.
Mack WJ, Hodis HN Efficacy of interventions designed to inhibit the progression of coronary atherosclerosis. Diabetes Res Clin Pract. 1996 Feb;30 Suppl:37-53. Review.
Mack WJ, Krauss RM, Hodis HN Lipoprotein subclasses in the Monitored Atherosclerosis Regression Study (MARS). Treatment effects and relation to coronary angiographic progression. Arterioscler Thromb Vasc Biol. 1996 May;16(5):697-704.
Markus RA, Mack WJ, Azen SP, Hodis HN Influence of lifestyle modification on atherosclerotic progression determined by ultrasonographic change in the common carotid intima-media thickness. Am J Clin Nutr. 1997 Apr;65(4):1000-4.
Vigen C, Hodis HN, Selzer RH, Mahrer PR, Mack WJ Relation of progression of coronary artery atherosclerosis to risk of cardiovascular events (from the Monitored Atherosclerosis Regression Study). Am J Cardiol. 2005 Jun 1;95(11):1277-82.
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.
