Crossover Versus Parallel Designs: Dose-Escalation Design Comparisons for First-In-Human Studies

REFERENCES

• Boon , P. C. , Roes , K. C. B. ( 1999 ). Design and analysis issues for crossover designs in Phase I clinical studies . Journal of Biopharmaceutical Statistics 9 ( 1 ): 109 – 128 .
   PubMedGoogle Scholar
• Glueck , D. H. , Muller , K. E. ( 2003 ). Adjusting power for a baseline covariate in linear models . Statistics in Medicine 22 : 2535 – 2551 .
   PubMed Web of Science ®Google Scholar
• Hedayat , A. S. , Jacroux , M. , Majumda , D. ( 1988 ). Optimal designs for comparing test treatments with controls . Statistical Science 3 ( 4 ): 462 – 491 .
   Google Scholar
• Jones , B. , Kenward , M. G. ( 2003 ). Design and Analysis of Cross-Over Trials. , 2nd ed. Boca Raton , FL : CRC Press .
   Google Scholar
• Peace , K. E. , Koch , G. G. ( 1993 ). Statistical methods for a three-period crossover design in which high dose cannot be used first . Journal of Biopharmaceutical Statistics 3 ( 1 ): 103 – 116 .
   PubMedGoogle Scholar
• Senn , S. ( 2002 ). Cross-Over Trials in Clinical Research (Statistics in Practice). , 2nd ed. New York , NY : Wiley .
   Google Scholar
• Senn , S. , Amin , D. , Bailey , R. A. , Bird , S. M. , Bogacka , B. , Colman , P. , Garrett , A. , Lachmann , P. ( 2007 ). Statistical issues in first-in-man studies . Journal of the Royal Statistical Society (Series A) 170 ( 3 ): 517 – 579 .
   Google Scholar
• Yang , M. , Stufken , J. ( 2008 ). Optimal and efficient crossover designs for comparing test treatments to a control treatment under various models . Journal of Statistical Planning and Inference 138 : 278 – 285 .
   Web of Science ®Google Scholar