Too much success, much too soon?

Good Clinical Practice Journal

Volumn 11, Issue 10, 2004, Pages 8-9

  Sashegyi, Andreas ^a  

^a ELI LILLY AND COMPANY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BEVACIZUMAB; DROTRECOGIN; NEW DRUG;

ANALYTICAL ERROR; ARTICLE; CANCER; CLINICAL TRIAL; DRUG APPROVAL; DRUG EFFICACY; DRUG RESEARCH; DRUG WITHDRAWAL; EVIDENCE BASED MEDICINE; GOOD CLINICAL PRACTICE; HUMAN; OUTCOMES RESEARCH; PRACTICE GUIDELINE; REGISTRATION; SEPSIS; STATISTICAL ANALYSIS; TIME; TREATMENT OUTCOME;

EID: 7244260327     PISSN: 13500961     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (6)

1. FDA. Draft Guidance for Clinical Trial Sponsors on the Establishment and Operation of Clinical Trial Data Monitoring Committees (www.fda.gov/cber/gdlns/clindatmon.pdf) November, 2001.
2. PC O'Brien, TR Fleming. 'A multiple testing procedure for clinical trials', Biometrics, 35, pp549-556, 1979.
3. DL DeMets, KK Lan. 'Interim analysis: the alpha spending function approach', Statistics in Medicine, 13, pp1341-1352, 1994.
4. R Katz. 'FDA: Evidentiary standards for drug development and approval', Journal of the American Society for Experimental NeuroTherapeutics, 1, pp307-316, 2004.
5. CPMP. Points to Consider on the Clinical Investigation of New Medicinal Products for the Treatment of Acute Coronary Syndrome Without Persistent ST-Segment Elevation, CPMP/EWP/570/98, February, 2000 (www.emea.eu.int/pdfs/human/ewp/057098en.pdf).
6. CPMP. Points to Consider on the Clinical Development of Fibrinolytic Medicinal Products in the Treatment of Patients with St Segment Elevation Acute Myocardial Infarction (STEMI), CPMP/EWP/570/98, June, 2000 (www.emea.eu.int/pdfs/human/ewp/096701en.pdf).