title: Ethics, error, and initial trials of efficacy.
abstract: Clinical trial reforms aimed at boosting phase 2 positive predictivity may involve ethical and social trade-offs.
authors: Studies for Translation, Ethics, and Medicine Group (STREAM), Biomedical Ethics Unit, McGill University, Montreal, QC H3A 1X1, Canada.
authors: Spencer Phillips
authors: SP
authors: Hey
authors: Jonathan
authors: J
authors: Kimmelman
mesh_terms: D017322:Clinical Trials, Phase II as Topic; D032984:Ethics, Research
references: Nat Rev Drug Discov. 2004 Aug;3(8):711-5
references: 15286737
references: J Clin Epidemiol. 2011 Jun;64(6):583-93
references: 21163620
references: Am Heart J. 2000 Apr;139(4):S136-42
references: 10740120
references: Kennedy Inst Ethics J. 2010 Mar;20(1):75-98
references: 20506695
references: Lancet. 2007 Mar 10;369(9564):815-6
references: 17366691
references: Pharm Stat. 2012 Mar-Apr;11(2):157-62
references: 22232067
references: PLoS Med. 2011 Mar;8(3):e1001010
references: 21423344
references: Science. 2010 May 14;328(5980):829-30
references: 20466907
references: Cancer J. 2009 Sep-Oct;15(5):426-30
references: 19826363
references: J Infect Dis. 2012 May 15;205 Suppl 2:S250-7
references: 22448027
references: J Clin Oncol. 2005 Oct 1;23(28):7199-206
references: 16192604
references: Nat Rev Immunol. 2011 Jan;11(1):57-64
references: 21179119
references: Science. 2012 May 4;336(6081):544-5
references: 22556237
references: Stat Med. 2010 May 10;29(10):1061-71
references: 20419758
references: J Clin Oncol. 2003 Oct 1;21(19):3683-95
references: 14512401
references: Contemp Clin Trials. 2007 Feb;28(2):138-45
references: 16843736
references: J Clin Oncol. 2005 Oct 1;23(28):6982-91
references: 16192585
references: J Natl Cancer Inst. 2007 Oct 3;99(19):1428-9
references: 17895467