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Volumn 23, Issue 10, 2004, Pages 1503-1505

Should statisticians reporting to data monitoring committees be independent of the trial sponsor and leadership?

Author keywords

Clinical trials; Conflict of interest; Data monitoring; Interim analysis

Indexed keywords

ACCURACY; ARTICLE; CLINICAL STUDY; CONFIDENTIALITY; CONFLICT; CONSENSUS DEVELOPMENT; FOOD AND DRUG ADMINISTRATION; HUMAN; INFORMATION PROCESSING; LEADERSHIP; MEDICAL INFORMATION; MEDICAL SPECIALIST; ORGANIZATION AND MANAGEMENT; PROFESSIONAL STANDARD; RESPONSIBILITY; STATISTICAL ANALYSIS;

EID: 2442686637     PISSN: 02776715     EISSN: None     Source Type: Journal    
DOI: 10.1002/sim.1784     Document Type: Article
Times cited : (21)

References (10)
  • 1
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    • Monitoring of clinical trials: Issues and recommendations
    • Fleming TR, DeMets DL. Monitoring of clinical trials: issues and recommendations. Controlled Clinical Trials 1993; 14:183-197.
    • (1993) Controlled Clinical Trials , vol.14 , pp. 183-197
    • Fleming, T.R.1    DeMets, D.L.2
  • 3
    • 0028136211 scopus 로고
    • Some practical aspects of the interim monitoring of clinical trials
    • Simon R. Some practical aspects of the interim monitoring of clinical trials. Statistics in Medicine 1994; 13:1401-1409.
    • (1994) Statistics in Medicine , vol.13 , pp. 1401-1409
    • Simon, R.1
  • 4
    • 0027529215 scopus 로고
    • Some FDA perspectives on data monitoring in clinical trials in drug development
    • O'Neill RT. Some FDA perspectives on data monitoring in clinical trials in drug development. Statistics in Medicine 1993; 12:601-608.
    • (1993) Statistics in Medicine , vol.12 , pp. 601-608
    • O'Neill, R.T.1
  • 5
    • 0035147112 scopus 로고    scopus 로고
    • Procedures of data and safety monitoring committees
    • Pocock S, Furberg CD. Procedures of data and safety monitoring committees. American Heart Journal 2001; 141:289-294.
    • (2001) American Heart Journal , vol.141 , pp. 289-294
    • Pocock, S.1    Furberg, C.D.2
  • 6
    • 0035094581 scopus 로고    scopus 로고
    • Terms of reference for data and safety monitoring committees
    • Packer M, Wittes J, Stump D. Terms of reference for data and safety monitoring committees. American Heart Journal 2001; 141:542-547.
    • (2001) American Heart Journal , vol.141 , pp. 542-547
    • Packer, M.1    Wittes, J.2    Stump, D.3
  • 7
    • 0037108141 scopus 로고    scopus 로고
    • Monitoring clinical trials: Issues and controversies regarding confidentiality
    • Fleming TR, Ellenberg SS, DeMets DL. Monitoring clinical trials: issues and controversies regarding confidentiality. Statistics in Medicine 2002; 21:2843-2851.
    • (2002) Statistics in Medicine , vol.21 , pp. 2843-2851
    • Fleming, T.R.1    Ellenberg, S.S.2    DeMets, D.L.3
  • 9
    • 0032430615 scopus 로고    scopus 로고
    • Clinical trials and treatment effects monitoring
    • Meinert CL. Clinical trials and treatment effects monitoring. Controlled Clinical Trials 1998; 19:515-522.
    • (1998) Controlled Clinical Trials , vol.19 , pp. 515-522
    • Meinert, C.L.1
  • 10
    • 85069095020 scopus 로고    scopus 로고
    • www.fda.gov/cber/gdlns/clindatmon.htm
    • www.fda.gov/cber/gdlns/clindatmon.htm.


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.