title: Unproven therapies in clinical research and practice: the necessity to change the regulatory paradigm.
authors.affiliation: Department of Pediatrics, University of Texas Health Science Center, 6431 Fannin St, MSB 2.106, Houston, TX 77098. susan.h.wootton@uth.tmc.edu.
authors.forename: Susan H
authors.initials: SH
authors.lastname: Wootton
authors.forename: Patricia W
authors.initials: PW
authors.lastname: Evans
authors.forename: Jon E
authors.initials: JE
authors.lastname: Tyson
mesh_terms: D035843:Biomedical Research / Q000331:legislation & jurisprudence*; D006801:Humans; D054582:National Institute of Child Health and Human Development (U.S.) / Q000331:legislation & jurisprudence*; D017410:Practice Guidelines as Topic; D014481:United States
keywords: clinical research; evidence based medicine; informed consent; institutional review board; quality improvement
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