Literature DB >> 24043278

Unproven therapies in clinical research and practice: the necessity to change the regulatory paradigm.

Susan H Wootton1, Patricia W Evans, Jon E Tyson.   

Abstract

Keywords:  clinical research; evidence based medicine; informed consent; institutional review board; quality improvement

Mesh：

Year:  2013        PMID： 24043278      PMCID： PMC3784293          DOI： 10.1542/peds.2013-0778

Source DB:  PubMed          Journal:  Pediatrics        ISSN： 0031-4005            Impact factor:   7.124


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  6 in total

1.  An ethics framework for a learning health care system: a departure from traditional research ethics and clinical ethics.

Authors:  Ruth R Faden; Nancy E Kass; Steven N Goodman; Peter Pronovost; Sean Tunis; Tom L Beauchamp
Journal:  Hastings Cent Rep       Date:  2013 Jan-Feb       Impact factor: 2.683

2.  The research-treatment distinction: a problematic approach for determining which activities should have ethical oversight.

Authors:  Nancy E Kass; Ruth R Faden; Steven N Goodman; Peter Pronovost; Sean Tunis; Tom L Beauchamp
Journal:  Hastings Cent Rep       Date:  2013 Jan-Feb       Impact factor: 2.683

3.  Antenatal consent in the SUPPORT trial: challenges, costs, and representative enrollment.

Authors:  Wade D Rich; Kathy J Auten; Marie G Gantz; Ellen C Hale; Angelita M Hensman; Nancy S Newman; Neil N Finer
Journal:  Pediatrics       Date:  2010-06-29       Impact factor: 7.124

Review 4.  Effect of timing of umbilical cord clamping and other strategies to influence placental transfusion at preterm birth on maternal and infant outcomes.

Authors:  Heike Rabe; Jose Luis Diaz-Rossello; Lelia Duley; Therese Dowswell
Journal:  Cochrane Database Syst Rev       Date:  2012-08-15

Review 5.  Resuscitation of newborn infants with 21% or 100% oxygen: an updated systematic review and meta-analysis.

Authors:  Ola Didrik Saugstad; Siddarth Ramji; Roger F Soll; Maximo Vento
Journal:  Neonatology       Date:  2008-07-09       Impact factor: 4.035

Review 6.  Outcomes of patients who participate in randomized controlled trials compared to similar patients receiving similar interventions who do not participate.

Authors:  Gunn Elisabeth Vist; Dianne Bryant; Lyndsay Somerville; Trevor Birminghem; Andrew D Oxman
Journal:  Cochrane Database Syst Rev       Date:  2008-07-16
  6 in total
  4 in total

Review 1.  When is waiver of consent appropriate in a neonatal clinical trial?

Authors:  Mark S Schreiner; Dalia Feltman; Thomas Wiswell; Susan Wootton; Cody Arnold; Jon Tyson; John D Lantos
Journal:  Pediatrics       Date:  2014-10-06       Impact factor: 7.124

Review 2.  The Misguided Regulation of Cardiac Emergencies: The Rise of the IRB-Industrial Complex and the Increasing Risk to Cardiovascular Research and Our Patients.

Authors:  Jay H Traverse
Journal:  Circ Res       Date:  2016-10-28       Impact factor: 17.367

3.  Randomized n-of-1 Trials: Quality Improvement, Research, or Both?

Authors:  Joyce P Samuel; Alyssa Burgart; Susan H Wootton; David Magnus; John D Lantos; Jon E Tyson
Journal:  Pediatrics       Date:  2016-07-06       Impact factor: 7.124

Review 4.  Research as a Standard of Care in the PICU.

Authors:  Jerry J Zimmerman; Kanwaljeet J S Anand; Kathleen L Meert; Douglas F Willson; Christopher J L Newth; Rick Harrison; Joseph A Carcillo; John Berger; Tammara L Jenkins; Carol Nicholson; J Michael Dean
Journal:  Pediatr Crit Care Med       Date:  2016-01       Impact factor: 3.624
  4 in total

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