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Original Articles

SOME OBSERVATIONS ON THE MAKUCH/SIMON APPROACH TO SAMPLE SIZE DETERMINATION IN CLINICAL TRIALS WITH HISTORICAL CONTROLS

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Pages 611-621 | Received 25 Oct 2000, Published online: 15 Feb 2007

REFERENCES

  • Makuch , R. W. and Simon , R. M. 1980 . Sample Size Considerations for Non-Randomized Comparative Studies . Journal of Chronic Disease , 33 : 175 – 181 .
  • Tarone , R. E. 1982 . The Use of Historical Control Information in Testing for a Trend in Proportions . Biometrics , 38 : 215 – 220 .
  • Thall , P. F. and Simon , R. M. 1990 . Incorporating Historical Control Data in Planning Phase II Clinical Trials . Statistics in Medicine , 9 : 215 – 228 .
  • Chang , M. N. , Shuster , J. J. and Kepner , J. L. 1999 . Group Sequential Designs for Phase II Trials with Historical Controls . Controlled Clinical Trials , 20 : 353 – 364 .

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