Performance and Sample Size Requirements of Bayesian Methods for Binary Outcomes in Fixed-Dose Combination Drug Studies

REFERENCES

• Abramowitz , M. , Stegun , I. A. ( 1965 ). Handbook of Mathematical Functions . New York : Dover .
   Google Scholar
• Branscum , A. J. , Johnson , W. O. , Gardner , I. A. ( 2007 ). Sample size calculations for studies designed to evaluate diagnostic test accuracy . J. Ag. Bio. Environ. Stat. 12 : 112 – 127 .
   Google Scholar
• Feng , P. , Kelly , C. ( 2004 ). An extension of the model free test to test synergy in multiple drug combinations . Biom. J. 46 : 293 – 304 .
   Web of Science ®Google Scholar
• Gibson , J. M. , Overall , J. E. (1989). The superiority of a drug combination over each of its components. Stat. Med. 8:1479–1484.
   PubMed Web of Science ®Google Scholar
• Hung , H. M. J. ( 1996 ). Global tests for combination drug studies in factorial trials . Stat. Med. 15 : 233 – 247 .
   PubMed Web of Science ®Google Scholar
• Hung , H. M. J. , Chi , G. Y. H. , Lipicky , R. J. ( 1993 ). Testing for the existence of a desirable dose combination . Biometrics 49 : 85 – 94 .
   PubMed Web of Science ®Google Scholar
• Joseph , L. , du Berger , R. , Bélisle , P. ( 1997 ). Bayesian and mixed Bayesian/likelihood criteria for sample size determination . Stat. Med. 16 : 769 – 781 .
   PubMed Web of Science ®Google Scholar
• Laska , E. M. , Meisner , M. J. ( 1989 ). Testing whether an identified treatment is best . Biometrics 45 : 1139 – 1151 .
   PubMed Web of Science ®Google Scholar
• Laska , E. M. , Meisner , M. , Seigel , C. ( 1994 ). Simple designs and model-free tests for synergy . Biometrics 50 : 834 – 841 .
   PubMed Web of Science ®Google Scholar
• Laska , E. M. , Meisner , M. , Tang , D. I. ( 1997 ). Classification of the effectiveness of combination treatments . Stat. Med. 16 : 2211 – 2228 .
   PubMed Web of Science ®Google Scholar
• Lowe , S. ( 1953 ). The problem of synergism and antagonism of combined drugs . Arzneimettelforschung 3 : 285 – 290 .
   PubMedGoogle Scholar
• Miller , M. A. , Seaman , J. W. , Jr. ( 1998 ). A Bayesian approach to assessing the superiority of a dose combination . Biom. J. 40 : 43 – 55 .
   Google Scholar
• O'Malley , A. J. , Normand , S.-L. T. , Kuntz , R. E. ( 2002 ). Sample size calculations for a historically controlled clinical trial with adjustments for covariates . J. Biopharm. Stat. 12 : 227 – 247 .
   PubMedGoogle Scholar
• Sarkar , S. K. , Snapinn , S. , Wang , W. ( 1995 ). On improving the min test for the analysis of combination drug trials . J. Stat. Comp. Sim. 51 : 197 – 213 .
   Web of Science ®Google Scholar
• Sidik , K. , Jonkman , J. N. ( 2003 ). Sample size determination in fixed-dose combination drug studies . Pharm. Stat. 2 : 273 – 278 .
   Web of Science ®Google Scholar
• Snapinn , S. M. ( 1987 ). Evaluating the efficacy of a combination therapy . Stats. Med. 6 : 657 – 665 .
   PubMed Web of Science ®Google Scholar
• Wang , F. , Gelfand , A. E. ( 2002 ). A simulation-based approach to Bayesian sample size determination for performance under a given model and for separating models . Stat. Sci. 17 : 93 – 208 .
   Google Scholar
• Wang , S. J. , Hung , H. M. J. ( 1997 ). Large sample tests for binary outcomes in fixed-dose combination drug studies . Biometrics 53 : 498 – 503 .
   PubMed Web of Science ®Google Scholar
• Zou , K. H. , Normand , S.-L. T. ( 2001 ). On determination of sample size in hierarchical binomial models . Stat. Med. 20 : 2163 – 2182 .
   PubMed Web of Science ®Google Scholar