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Original Articles

Adaptive Group Sequential Test with Changing Patient Population

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Pages 662-678 | Received 01 Jun 2010, Accepted 15 Feb 2012, Published online: 31 May 2012

REFERENCES

  • Chow , S. C. , Shao , J. ( 2005 ). Inference for clinical trials with some protocol amendments . Journal of Biopharmaceutical Statistics 15 ( 4 ): 659 – 666 .
  • Jennison , C. , Turnbull , B. W. ( 2000 ). Group Sequential Methods with Applications to Clinical Trials . Boca Raton , FL : Chapman & Hall/CRC .
  • Pocock , S. J. ( 1977 ). Group sequential methods in the design and analysis of clinical trials . Biometrika 64 ( 2 ): 191 – 199 .
  • Pocock , S. J. ( 1982 ). Interim analyses for randomized clinical trials: The group sequnetial approach . Biometrika 38 : 153 – 162 .
  • U.S. Food and Drug Administration ( 2010 ). Draft Guidance for Industry: Adaptive Design Clinial Trials for Drugs and Biologics. http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/UCM201790.pdf .

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