Assessment of clinical relevance by considering point estimates and associated confidence intervals

Pharmaceutical Statistics

Volumn 4, Issue 2, 2005, Pages 101-107

  Kieser, Meinhard ^a,b   Hauschke, Dieter ^c  

^a DR WILLMAR SCHWABE GMBH AND CO KG   (Germany)

^b UNIVERSITY OF HEIDELBERG   (Germany)

^c Altana Pharma ^*  (Germany)

Author keywords

Clinical relevance; Clinically important difference; Sample size; Statistical power; Statistical significance

Indexed keywords

ANTIDEPRESSANT AGENT; PLACEBO;

ARTICLE; CLINICAL STUDY; CLINICAL TRIAL; CONFIDENCE INTERVAL; DEPRESSION; DRUG APPROVAL; DRUG EFFICACY; HAMILTON SCALE; HUMAN; MEDICAL RESEARCH; PRACTICE GUIDELINE; PROBABILITY; SAMPLING; STATISTICAL SIGNIFICANCE; TREATMENT OUTCOME;

EID: 21244433490     PISSN: 15391604     EISSN: None     Source Type: Journal    
DOI: 10.1002/pst.161     Document Type: Article

References (17)

1. Committee for Proprietary Medicinal Products. Points to consider on the choice of non-inferiority margin (CPMP/EWP/2158/99, draft). EMEA: London, 2004. Available at www.emea.eu.int
2. Brown DJ. ICH E9 guideline 'Statistical principles for clinical trials': a case study. Response to A. Phillips and V. Haudiquet. Statistics in Medicine 2003; 22:13-17.
3. Victor N. On clinically relevant differences and shifted null hypotheses. Methods of Information in Medicine 1987; 26:109-116.
4. Committee for Proprietary Medicinal Products. Note for guidance on clinical investigation of medicinal products in the treatment of diabetes mellitus (CPMP/EWP/1080/00). EMEA: London, 2002. Available at www.emea.eu.int
5. Committee for Proprietary Medicinal Products. Note for guidance on clinical investigation of medicinal products in the treatment of Parkinsons disease (CPMP/EWP/563/95). EMEA: London, 1998. Available at www.emea.cu.int
6. Committee for Proprietary Medicinal Products. Note for guidance on medicinal products in the treatment of Alzheimers disease (CPMP/EWP/553/95). EMEA: London, 1997. Available at www.emea.eu.int
7. Senn S. Disappointing dichotomies. Pharmaceutical Statistics 2003; 2:239-240.
8. Lewis JA. In defence of the dichotomy. Pharmaceutical Statistics 2004; 3:77-79.
9. Kieser M, Röhmel J, Friede T. Power and sample size determination when assessing the clinical relevance of trial results by 'responder analyses'. Statistics in Medicine 2004; 23:3287-3305.
10. Committee for Proprietary Medicinal Products. Note for guidance on statistical principles for clinical trials (CPMP/ICH/363 /96). EMEA: London, 1998. Available at www.emea.eu.int
11. Committee for Proprietary Medicinal Products. Points to consider on switching between superiority and non-inferiorty (CPMP/EWP/482/99). EMEA: London, 2000. Available at www.emea.eu.int
12. Jones PW. Interpreting thresholds for a clinically significant change in health status in asthma and COPD. European Respiratory Journal 2002; 19:396-404.
13. Hamilton M. A rating scale for depression. Journal of Neurology, Neurosurgery and Psychiatry 1960; 23:56-62.
14. Montgomery SA. Clinically relevant effect sizes in depression. European Neuropsychopharmacology 1994; 4:283-284.
15. Chow SC, Shao J, Wang H. Sample size calculations in clinical research. Marcel Dekker: New York, 2003.
16. Committee for Proprietary Medicinal Products. Points to consider on clinical investigation of medicinal products for the treatment of neuropathic pain (CPMP/EWP/252/03 draft). EMEA: London, 2004. Available at www.emea.eu.int
17. Phillips A, Haudiquet V. ICH E9 guideline 'Statistical principles for clinical trials': a case study. Statistics in Medicine 2003; 22: 1-11.