The role of the unblinded sponsor statistician

Statistics in Medicine

Volumn 23, Issue 10, 2004, Pages 1531-1533

  Snapinn, Steven ^a,b   Cook, Thomas ^a   Shapiro, Deborah ^a   Snavely, Duane ^a  

^a MERCK RESEARCH LABORATORIES   (United States)

^b NONE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLINICAL STUDY; CONFIDENTIALITY; DATA BASE; DRUG INDUSTRY; EMPLOYEE; EXPERIMENTATION; HUMAN; LEADERSHIP; MEDICAL ETHICS; MEDICAL SPECIALIST; PROFESSIONAL STANDARD; QUALITY CONTROL; RESPONSIBILITY; STATISTICAL ANALYSIS;

BIOMEDICAL AND BEHAVIORAL RESEARCH;

CLINICAL TRIALS; CLINICAL TRIALS DATA MONITORING COMMITTEES; DRUG INDUSTRY; ETHICS, PROFESSIONAL; FEMALE; HUMANS; MALE; STATISTICS;

EID: 2442645153     PISSN: 02776715     EISSN: None     Source Type: Journal    
DOI: 10.1002/sim.1790     Document Type: Article

References (5)

1. www.fda.gov/cber/gdlns/clindatmon.htm.
2. Scandinavian Simvastatin Survival Study Group. Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: The Scandinavian Simvastatin Survival Study (4S). The Lancet 1994; 344:1383-1389.
3. Downs JR, Clearfield M, Weis S, Whitney E, Shapiro DR, Beere PA, Langendorfer A, Stein EA, Kruyer W, Gotto Jr AM (for the AFCAPS/TexCAPS Research Group). Primary prevention of acute coronary events with lovastatin in men and women with average cholesterol levels: results of AFCAPS/TexCAPS. Journal of the American Medical Association 1998; 279:1615-1622.
4. Brenner, BM, Cooper ME, DeZeeuw D, Keane WF, Mitch WE, Parving H-H, Remuzzi G, Snapinn SM, Zhang Z, Shahinfar S. Effects of losartan on renal and cardiovascular outcomes in patients with type 2 diabetes and nephropathy. New England Journal of Medicine 2001; 345:861-869.
5. Dahlöf B, Devereux RB, Kjeldsen SE, Julius S, Beevers G, de Faire U, Fyhrquist F, Ibsen H, Kristianson K, Lederballe-Pedersen O, Lindholm LH, Nieminen MS, Omvik P, Oparil S, Wedel H for the LIFE Study Group. Cardiovascular morbidity and mortality in the Losartan Intervention For Endpoint reduction in hypertension study (LIFE): a randomised trial against atenolol. The Lancet 2001; 359:995-1003.