Identifying and addressing safety signals in clinical trials

New England Journal of Medicine

Volumn 359, Issue 13, 2008, Pages 1400-1402

  Fleming, Thomas R ^a  

^a UNIVERSITY OF WASHINGTON   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CELECOXIB; CYCLOOXYGENASE 2 INHIBITOR; EZETIMIBE; EZETIMIBE PLUS SIMVASTATIN; IBUPROFEN; NAPROXEN; NONSTEROID ANTIINFLAMMATORY AGENT; PLACEBO; SIMVASTATIN;

AORTA VALVE STENOSIS; CANCER CELL; CANCER RISK; CARDIOVASCULAR DISEASE; CLINICAL TRIAL; DRUG FATALITY; DRUG SAFETY; EDITORIAL; GASTROINTESTINAL ABSORPTION; GASTROINTESTINAL SYMPTOM; HEART INFARCTION; HEART PROTECTION; HIGH RISK PATIENT; HUMAN; MEDICAL RESEARCH; NEOPLASM; OSTEOARTHRITIS; PRIORITY JOURNAL; RANDOMIZATION; RENAL PROTECTION; RHEUMATOID ARTHRITIS; RISK ASSESSMENT; SIDE EFFECT; STROKE;

EID: 52649135630     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMe0807372     Document Type: Editorial

References (9)

1. O'Neill RT. Secondary endpoints cannot be validly analyzed if the primary endpoint does not demonstrate clear statistical significance. Control Clin Trials 1997;18:550-6.
2. Fleming TR, Sharples K, Mall J, Moore A, Rodgers A, Stewart R. Maintaining confidentiality of interim data to enhance trial integrity and credibility. Clin Trials 2008;5:157-67.
3. Rossebø AB, Pedersen TR, Boman K, et al. Intensive lipid lowering with simvastatin and ezetimibe in aortic stenosis. N Engl J Med 2008;359:1343-56.
4. Bradford PG, Awad AB. Phytosterols as anticancer compounds. Mol Nutr Food Res 2007;51:161-70.
5. Assmann G, Kannenbert F, Ramey DR, Musliner TA, Gutkin SW, Veltri EP. Effects of ezetimibe, simvastatin, atorvastatin, and ezetimibe-statin therapies on non-cholesterol sterols in patients with primary hypercholesterolemia. Curr Med Res Opin 2008;24:249-59.
6. Imanaka H, Koide H, Shimizu S, et al. Chemoprevention of tumor metastasis by liposomal β-sitosterol intake. Biol Pharm Bull 2008;31:400-4.
7. Fleming TR. Current issues in non-inferiority trials. Stat Med 2008;27:317-32.
8. Peto R, Emberson J, Landray M, et al. Analyses of cancer data from three ezetimibe trials. N Engl J Med 2008;359:1357-66.
9. Ellenberg SS, Fleming TR, Dets DL. Data monitoring committees in clinical trials: a practical perspective. Chichester, England: John Wiley, 2002.