Jang JH, Park WB, Lim YS, Choi JY, Cho JS, Woo JH, Choi WS, Yang HJ, Hyun SY Combination of S100B and procalcitonin improves prognostic performance compared to either alone in patients with cardiac arrest: A prospective observational study. Medicine (Baltimore). 2019 Feb;98(6):e14496. doi: 10.1097/MD.0000000000014496.
Linssen J, Aderhold S, Nierhaus A, Frings D, Kaltschmidt C, Zanker K Automation and validation of a rapid method to assess neutrophil and monocyte activation by routine fluorescence flow cytometry in vitro. Cytometry B Clin Cytom. 2008 Sep;74(5):295-309. doi: 10.1002/cyto.b.20422.
Sevenet PO, Depasse F Clot waveform analysis: Where do we stand in 2017? Int J Lab Hematol. 2017 Dec;39(6):561-568. doi: 10.1111/ijlh.12724. Epub 2017 Sep 6.
Toh CH, Ticknor LO, Downey C, Giles AR, Paton RC, Wenstone R Early identification of sepsis and mortality risks through simple, rapid clot-waveform analysis. Implications of lipoprotein-complexed C reactive protein formation. Intensive Care Med. 2003 Jan;29(1):55-61. doi: 10.1007/s00134-002-1557-2. Epub 2002 Nov 22.
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.
