Rejoinder to "establishing efficacy of a new experimental treatment in the 'gold standard design"

Biometrical Journal

Volumn 47, Issue 6, 2005, Pages 797-798

  Hauschke, Dieter ^a   Pigeot, Iris ^a  

^a NONE

Author keywords

Assay Sensitivity; Fieller's Confidence Interval; Gold Standard Design; Proof of Efficacy; Relative Efficacy

Indexed keywords

ASSAY SENSITIVITY; CONFIDENCE INTERVAL; FIELLE CONFIDENCE INTERVAL; GOLD STANDARD DESIGN; GOLD STANDARDS; PROOF OF EFFICACY; RELATIVE EFFICACY; STANDARD DESIGN;

EID: 29844451225     PISSN: 03233847     EISSN: None     Source Type: Journal    
DOI: 10.1002/bimj.200510179     Document Type: Review

References (9)

1. Committee for Proprietary Medicinal Products (2000). Note for guidance on the choice of control group in clinical trials (CPMP/ICH/364/96). EMEA London.
2. Committee for Proprietary Medicinal Products (2002). Note for guidance on the clinical investigation of medicinal products in the treatment of asthma. (CPMP/EWP/2922/01). EMEA London.
3. Committee for Proprietary Medicinal Products (2003). Note for guidance on the clinical investigation of medicinal products for the treatment of migraine. (CPMP/EWP/788/01). EMEA London.
4. Committee for Medicinal Products for Human Use (2005). Guideline on the choice of the non-inferiority margin. (CPMP/EWP/2158/99). EMEA London.
5. Committee for Medicinal Products for Human Use (2005). Note for guidance on the clinical investigation of medicinal products indicated for the treatment of panic disorder. (CPMP/EWP/4280/02). EMEA London.
6. Kieser, M. and Hauschke, D. (2005). Assessment of clinical relevance by considering point estimates and associated confidence intervals. Pharmaceutical Statistics 4, 101-107.
7. Koch, A. and Röhmel, J. (2004). Hypothesis testing in the "gold standard" design for proving the efficacy of an experimental treatment relative to placebo and a reference. Journal of Biopharmaceutical Statistics 14, 315-325.
8. Pigeot, I., Schäfer, J., Röhmel, J., and Hauschke, D. (2003). Assessing non-inferiority of a new treatment in a three-arm clinical trial including a placebo. Statistics in Medicine 22, 883-899.
9. Röhmel, J. (2005). On confidence bounds for the ratio of net differences in the "gold standard" design with reference, experimental, and placebo treatment. Biometrical Journal DOI 10.1002/bimj.200510178.