Kessler T, Vilne B, Schunkert H The impact of genome-wide association studies on the pathophysiology and therapy of cardiovascular disease. EMBO Mol Med. 2016 Jul 1;8(7):688-701. doi: 10.15252/emmm.201506174. Print 2016 Jul.
Muse ED, Chen SF, Torkamani A Monogenic and Polygenic Models of Coronary Artery Disease. Curr Cardiol Rep. 2021 Jul 1;23(8):107. doi: 10.1007/s11886-021-01540-0.
Navas-Nacher EL, Colangelo L, Beam C, Greenland P Risk factors for coronary heart disease in men 18 to 39 years of age. Ann Intern Med. 2001 Mar 20;134(6):433-9. doi: 10.7326/0003-4819-134-6-200103200-00007. Erratum In: Ann Intern Med 2001 Jul 3;135(1):71.
Saadatagah S, Varughese MG, Nambi V Coronary Artery Disease Risk Prediction in Young Adults: How Can We Overcome the Dominant Effect of Age? Curr Atheroscler Rep. 2023 Jun;25(6):257-265. doi: 10.1007/s11883-023-01106-1. Epub 2023 May 17.
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.
