Clinical Trials in Neonates: Ethical Issues
Seminars in Fetal and Neonatal Medicine 2007 August; 12(4): 318-323
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Amin, Sanjiv B.; McDermott, Michael P.; Shamoo, Adil E. (2008-07)The use of drugs for indications unapproved by the Food and Drug Administration (FDA), often called "off label use, "is widespread in children, including neonates. The widespread off-label use of drugs in neonates presents ...
Methodological Issues and Controversies in Clinical Trials With Child and Adolescent Patients With Bipolar Disorder: Report of a Consensus Conference Carlson, Gabrielle A.; Jensen, Peter S.; Findling, Robert L.; Meyer, Roger E.; Calabrese, Joseph; DelBello, Melissa P.; Emslie, Graham; Flynn, Laurie; Goodwin, Frederick; Hellander, Martha; Kowatch, Robert; Kusumakar, Vivek; Laughren, Thomas; Leibenluft, Ellen; McCracken, James; Nottelmann, Editha; Pine, Daniel; Sachs, Gary; Shaffer, David; Simar, Renee; Strober, Michael; Weller, Elizabeth B.; Wozniak, Janet; Youngstrom, Eric A. (2003-03)
Allmark, Peter (1999-08)My aim is to suggest that there is a case for using a randomised consent design in some neonatal trials. As an example I use the trials of extracorporeal membrane oxygenation (ECMO) in neonates suffering pulmonary hypertension. ...