Garrett WS, Gordon JI, Glimcher LH Homeostasis and inflammation in the intestine. Cell. 2010 Mar 19;140(6):859-70. doi: 10.1016/j.cell.2010.01.023. Review.
Giuffrida P, Corazza GR, Di Sabatino A Old and New Lymphocyte Players in Inflammatory Bowel Disease. Dig Dis Sci. 2018 Feb;63(2):277-288. doi: 10.1007/s10620-017-4892-4. Epub 2017 Dec 23. Review.
Kim JC, Jin HM, Cho YN, Kwon YS, Kee SJ, Park YW Deficiencies of Circulating Mucosal-associated Invariant T Cells and Natural Killer T Cells in Patients with Acute Cholecystitis. J Korean Med Sci. 2015 May;30(5):606-11. doi: 10.3346/jkms.2015.30.5.606. E
Meierovics A, Yankelevich WJ, Cowley SC MAIT cells are critical for optimal mucosal immune responses during in vivo pulmonary bacterial infection. Proc Natl Acad Sci U S A. 2013 Aug 13;110(33):E3119-28. doi: 10.1073/pnas.1302799110. Epub 2013 Jul 29.
Meierovics AI, Cowley SC MAIT cells promote inflammatory monocyte differentiation into dendritic cells during pulmonary intracellular infection. J Exp Med. 2016 Nov 14;213(12):2793-2809. Epub 2016 Oct 31.
Miyazaki Y, Miyake S, Chiba A, Lantz O, Yamamura T Mucosal-associated invariant T cells regulate Th1 response in multiple sclerosis. Int Immunol. 2011 Sep;23(9):529-35. doi: 10.1093/intimm/dxr047. Epub 2011 Jun 28.
Napier RJ, Adams EJ, Gold MC, Lewinsohn DM The Role of Mucosal Associated Invariant T Cells in Antimicrobial Immunity. Front Immunol. 2015 Jul 6;6:344. doi: 10.3389/fimmu.2015.00344. eCollection 2015. Review.
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.