Choi BG, Rha SW, Yoon SG, Choi CU, Lee MW, Kim SW Association of Major Adverse Cardiac Events up to 5 Years in Patients With Chest Pain Without Significant Coronary Artery Disease in the Korean Population. J Am Heart Assoc. 2019 Jun 18;8(12):e010541. doi
Khanna AK, Overdyk FJ, Greening C, Di Stefano P, Buhre WF Respiratory depression in low acuity hospital settings-Seeking answers from the PRODIGY trial. J Crit Care. 2018 Oct;47:80-87. doi: 10.1016/j.jcrc.2018.06.014. Epub 2018 Jun 18.
Schaefer MS, Eikermann M Contact-free respiratory monitoring using bed wheel sensors: a valid respiratory monitoring technique with significant potential impact on public health. J Appl Physiol (1985). 2019 May 1;126(5):1430-1431. doi: 10.1152/japplphysi
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.
