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Original Articles

Decision Making from Phase II to Phase III and the Probability of Success: Reassured by “Assurance”?

Pages 1188-1200 | Received 29 Nov 2012, Accepted 19 Mar 2013, Published online: 19 Aug 2013

REFERENCES

  • Arrowsmith , J. ( 2011a ). Phase II failures: 2008–2010 . Nature Reviews Drug Discovery 10 : 328 – 329 .
  • Arrowsmith , J. ( 2011b ). Phase III and submission failures: 2007–2010 . Nature Reviews Drug Discovery 10 : 87 – 88 .
  • AstraZeneca Plc. (2012). Remaining TC-5214 Phase III Efficacy Studies Do Not Meet Endpoint, Regulatory Filing Will Not Be Pursued. March 20. Available at: http:// www.astrazeneca.com///Media/Press-releases///Article///20032012tc5214-failed-Phase-iii-endpoint
  • AtheroGenics, Inc. (2004). AtheroGenics Reports Positive Final Results from CART-2 Clinical Trial of AGI-1067. AGI-1067 Achieves Statistically Significant Plaque Regression Versus Baseline. November 22. Available at: http://www.sec.gov/ Archives/edgar/data/1107601/000110760104000056/exhibit99 prfinalresults.htm
  • Chuang-Stein , C. ( 2006 ). Sample size and the probability of a successful trial . Pharmaceutical Statististics 5 : 30 – 309 .
  • Chuang-Stein , C. , Kirby , S. , French , F. , Kowalski , K. , Marshall , S. , Smith , M. K. , Bycott , P. , Beltangady , M. (2011). A quantitative approach for making go/no go decisions in drug development. Drug Information Journal 45:187–202.
  • Doody , R. S. , Gavrilova , S. I. , Sano , M. , Thomas , R. G. , Aisen , P. S. , Bachurin , S. O. , Seely , L. , Hung , D. ( 2008 ). Effect of dimebon on cognition, activities of daily living, behaviour, and global function in patients with mild-to-moderate Alzheimer's disease: A randomised, double-blind, placebo-controlled study . Lancet 372 : 207 – 215 .
  • Dunbar , G. ( 2009 ). Positive effects of the nicotinic channel blocker TC-5214 as augmentation treatment in patients with major depressive disorder who are inadequate responders to a first-line SSRI. nAChR2009 satellite meeting of the 39th annual meeting of the Society for Neuroscience; 2009. Slides available at http://www.faqs.org/sec-filings/ 091016/TARGACEPT-INC_8-K/dex991.htm
  • King , M. ( 2009 ). Evaluating probability of success in oncology clinical trials. BASS XVI, November. Available at: http://www.bassconference.org/PDFs/Bass%202009%20 Martin%20King.pdf
  • Kirby , S. , Burke , J. , Chuang-Stein , C. , Sin , C. ( 2012 ). Discounting phase 2 results when planning phase 3 clinical trials . Pharmaceutical Statistics 11 : 373 – 385 .
  • Medivation, Inc. (2010). Pfizer And Medivation Announce Results From Two Phase 3 Studies in Dimebon (latrepirdine*) Alzheimer's Disease Clinical Development Program. March 3. Available at: http://investors.medivation.com/releasedetail. cfm?ReleaseID = 448818
  • O'Hagan , A. , Stevens , J. W. , Campbell , M. J. ( 2005 ). Assurance in clinical trial design . Pharmaceutical Statistics 4 : 18 – 201 .
  • O'Shaughnessy , J. , Osborne , C. , Pippen , J. E. , Yoffe , M. , Patt , D. , Rocha , C. , Koo , I. C. , Sherman , B. M. , Bradley , C. ( 2011a ). Iniparib plus chemotherapy in metastatic triple-negative breast cancer . New England Journal of Medicine 364 : 205 – 214 .
  • O'Shaughnessy , J. , Schwartzberg , L. S. , Danso , M. A. , Rugo , H. S. , Miller , K. , Yardley , D. A. , Carlson , R. W. , Finn , R. S. , Charpentier , E. , Freese , M. , Gupta , S. , Blackwood-Chirchir , S. , Winer , E. P. ( 2011b ). A randomized phase III study of iniparib (BSI-201) in combination with gemcitabine/carboplatin (G/C) in metastatic triple-negative breast cancer (TNBC). Journal of Clinical Oncology 29(suppl.):abstract 1007 .
  • Prinz , F. , Schlange , T. , Asadullah , K. ( 2011 ). Believe it or not: How much can we rely on published data on potential drug targets? Nature Review Drug Discovery 10 : 712 – 713 .
  • Tardif , J.-C. , McMurray , J. J. , Klug , E. , Small , R. , Schumi , J. , Choi , J. , Cooper , J. , Scott , R. , Lewis , E. F. , L'Allier , P. L. , Pfeffer , M. A. ( 2008 ). Effects of succinobucol (AGI-1067) after an acute coronary syndrome: A randomised, double-blind, placebo-controlled trial . Lancet 371 : 1761 – 1768 .

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