Self-Injurious Behavior — A Clinical Trial for Self-Injurious Behavior
Citation(s)
Hagopian LP, Frank-Crawford MA Classification of self-injurious behaviour across the continuum of relative environmental-biological influence. J Intellect Disabil Res. 2018 Dec;62(12):1108-1113. doi: 10.1111/jir.12430. Epub 2017 Oct 13.
Hagopian LP, Rooker GW, Zarcone JR, Bonner AC, Arevalo AR Further analysis of subtypes of automatically reinforced SIB: A replication and quantitative analysis of published datasets. J Appl Behav Anal. 2017 Jan;50(1):48-66. doi: 10.1002/jaba.368. Epub 2016 Dec 29.
Hagopian LP, Rooker GW, Zarcone JR Delineating subtypes of self-injurious behavior maintained by automatic reinforcement. J Appl Behav Anal. 2015 Sep;48(3):523-43. doi: 10.1002/jaba.236. Epub 2015 Jul 29.
A Clinical Trial for Treatment-Resistant Subtypes of Self-Injurious Behavior
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.
