메뉴 건너뛰기




Volumn 31, Issue 3, 2009, Pages 325-342

Who's minding the data? Data Monitoring committees in clinical cancer trials

Author keywords

Biomedicine; Clinical trials; Committees; Data monitoring; Objectivity; Regulation

Indexed keywords

ARTICLE; BIOMETRY; CLINICAL TRIAL; HISTORY; HUMAN; INFORMATION SYSTEM; MEDICAL RESEARCH; NEOPLASM; ORGANIZATION AND MANAGEMENT; PROFESSIONAL STANDARD; STATISTICS;

EID: 63849221533     PISSN: 01419889     EISSN: 14679566     Source Type: Journal    
DOI: 10.1111/j.1467-9566.2008.01136.x     Document Type: Article
Times cited : (17)

References (43)
  • 1
    • 0027469610 scopus 로고
    • Panel discussion: Scientific issues in data monitoring
    • Anonymous
    • Anonymous 1993) Panel discussion: scientific issues in data monitoring, Statistics in Medicine, 12, 583 600.
    • (1993) Statistics in Medicine , vol.12 , pp. 583-600
  • 2
    • 0035884586 scopus 로고    scopus 로고
    • Theory and practice in medical statistics
    • Armitage, P. (2001) Theory and practice in medical statistics, Medical Statistics, 20, 2537 48.
    • (2001) Medical Statistics , vol.20 , pp. 2537-48
    • Armitage, P.1
  • 5
    • 33646375164 scopus 로고    scopus 로고
    • Regulatory objectivity and the generation and management of evidence in medicine
    • Cambrosio, A., Keating, P., Schlich, T. Weisz, G. (2006) Regulatory objectivity and the generation and management of evidence in medicine, Social Science & Medicine, 63, 189 199.
    • (2006) Social Science & Medicine , vol.63 , pp. 189-199
    • Cambrosio, A.1    Keating, P.2    Schlich, T.3    Weisz, G.4
  • 6
    • 63849278093 scopus 로고    scopus 로고
    • Objectivité régulatoire et systèmes de preuves en médecine: Le cas de la cancérologie
    • In. Tournay, V. (ed.). Paris. Presses Universitaires de France.
    • Cambrosio, A., Keating, P. Bourret, P. (2007) Objectivité régulatoire et systèmes de preuves en médecine: Le cas de la cancérologie. In Tournay, V. (ed.) La gouvernance des innovations biomédicales. Paris : Presses Universitaires de France.
    • (2007) La Gouvernance des Innovations Biomédicales.
    • Cambrosio, A.1    Keating, P.2    Bourret, P.3
  • 7
    • 0017695033 scopus 로고
    • Monitoring treatment differences in long-term clinical trials
    • Canner, P.L. (1977) Monitoring treatment differences in long-term clinical trials, Biometrics, 33, 603 15.
    • (1977) Biometrics , vol.33 , pp. 603-15
    • Canner, P.L.1
  • 8
    • 84972654381 scopus 로고
    • Objectivity and the escape from perspective
    • Daston, L. (1992) Objectivity and the escape from perspective, Social Studies of Science, 22, 597 618.
    • (1992) Social Studies of Science , vol.22 , pp. 597-618
    • Daston, L.1
  • 9
    • 84966854808 scopus 로고
    • The image of objectivity
    • Daston, L. Galison, P. (1992) The image of objectivity, Representations, 40, 81 128.
    • (1992) Representations , vol.40 , pp. 81-128
    • Daston, L.1    Galison, P.2
  • 11
    • 2442686637 scopus 로고    scopus 로고
    • Should statisticians reporting to data monitoring committees be independent of the trial sponsor and leadership?
    • Ellenberg, S.S. George, S.L. (2004) Should statisticians reporting to data monitoring committees be independent of the trial sponsor and leadership?, Statistics in Medicine, 23, 1503 05.
    • (2004) Statistics in Medicine , vol.23 , pp. 1503-05
    • Ellenberg, S.S.1    George, S.L.2
  • 14
    • 63849331035 scopus 로고    scopus 로고
    • European Medicine Agency (EMEA), Committee for Medicinal Products for Human Use (CHMP)
    • EMEA. London. 27 July 2005)
    • EMEA 2005) European Medicine Agency (EMEA), Committee for Medicinal Products for Human Use (CHMP), Guideline on Data Monitoring Committees (London, 27 July 2005) http://www.emea.eu.int/pdfs/human/ewp/587203en.pdf
    • (2005) Guideline on Data Monitoring Committees
  • 16
    • 2542465496 scopus 로고    scopus 로고
    • FDA. , Guidance for Clinical Trial Sponsors. On the Establishment and Operation of Clinical Trial Data Monitoring Committees. Draft Guidance
    • FDA 2001a) Food and Drug Administration, Guidance for Clinical Trial Sponsors. On the Establishment and Operation of Clinical Trial Data Monitoring Committees. Draft Guidance http://www.fda.gov/Cber/gdlns/clindatmon.pdf
    • (2001) Food and Drug Administration
  • 17
    • 63849120021 scopus 로고    scopus 로고
    • FDA Guidance on Clinical Trial Data Monitoring Committees (DMCs)
    • FDA. (DMCs). Tuesday, November 27, 2001. Hyatt Regency Bethesda. Rockville (MD)
    • FDA 2001b) FDA Guidance on Clinical Trial Data Monitoring Committees (DMCs). Open Public Meeting, FDA Guidance on Clinical Trial Data Monitoring Committees (DMCs). Tuesday, November 27, 2001. Hyatt Regency Bethesda, Rockville (MD)
    • (2001) Open Public Meeting, FDA Guidance on Clinical Trial Data Monitoring Committees
  • 18
    • 63849187622 scopus 로고    scopus 로고
    • part 1
    • part 1: http://www.fda.gov/cber/minutes/clinmon1101p1.htm
  • 19
    • 63849116341 scopus 로고    scopus 로고
    • part 2
    • part 2: http://www.fda.gov/cber/minutes/clinmon1101p2.htm
  • 20
    • 2542465496 scopus 로고    scopus 로고
    • FDA. , Guidance for Clinical Trial Sponsors. Establishment and Operation of Clinical Trial Data Monitoring Committees
    • FDA. (2006) Food and Drug Administration, Guidance for Clinical Trial Sponsors. Establishment and Operation of Clinical Trial Data Monitoring Committees http://www.fda.gov/CBER/gdlns/clintrialdmc.pdf
    • (2006) Food and Drug Administration
  • 21
    • 0035092538 scopus 로고    scopus 로고
    • The role of an independent statistical analysis center in the industry-modified National Institutes of Health model
    • Fisher, M., Roeker, E.B. DeMets, D.L. (2001) The role of an independent statistical analysis center in the industry-modified National Institutes of Health model, Drug Information Journal, 35, 115 29.
    • (2001) Drug Information Journal , vol.35 , pp. 115-29
    • Fisher, M.1    Roeker, E.B.2    Demets, D.L.3
  • 25
    • 0023874973 scopus 로고
    • Organization, review, and administration of cooperative studies: A report from the Heart Special Project Committee to the National Advisory Heart Council, May 1967
    • Greenberg Report
    • Greenberg Report 1988) Organization, review, and administration of cooperative studies: a report from the Heart Special Project Committee to the National Advisory Heart Council, May 1967, Controlled Clinical Trials, 9, 137 48.
    • (1988) Controlled Clinical Trials , vol.9 , pp. 137-48
  • 27
    • 0015131639 scopus 로고
    • Repeated assessment of results in clinical trials of cancer treatment
    • Haybittle, J.L. (1971) Repeated assessment of results in clinical trials of cancer treatment, British Journal of Radiology, 44, 793 7.
    • (1971) British Journal of Radiology , vol.44 , pp. 793-7
    • Haybittle, J.L.1
  • 28
    • 34047116249 scopus 로고    scopus 로고
    • Cancer clinical trials: The emergence and development of a new style of practice
    • Keating, P. Cambrosio, A. (2007) Cancer clinical trials: the emergence and development of a new style of practice, Bulletin of the History of Medicine, 81, 197 223.
    • (2007) Bulletin of the History of Medicine , vol.81 , pp. 197-223
    • Keating, P.1    Cambrosio, A.2
  • 30
    • 14744302255 scopus 로고    scopus 로고
    • Treatment effects monitoring committees and early stopping in large clinical trials
    • Kiri, A., Tonascia, S. Meinert, C.L. (2004) Treatment effects monitoring committees and early stopping in large clinical trials, Clinical Trials, 1, 40 7.
    • (2004) Clinical Trials , vol.1 , pp. 40-7
    • Kiri, A.1    Tonascia, S.2    Meinert, C.L.3
  • 31
    • 84973676578 scopus 로고
    • Technical work and critical inquiry: Investigations in a scientific laboratory
    • Lynch, M.E. (1982) Technical work and critical inquiry: investigations in a scientific laboratory, Social Studies of Science, 12, 499 533.
    • (1982) Social Studies of Science , vol.12 , pp. 499-533
    • Lynch, M.E.1
  • 33
    • 0016403659 scopus 로고
    • Statistics: The problem of examining accumulating data more than once
    • McPherson, K. (1974) Statistics: the problem of examining accumulating data more than once, New England Journal of Medicine, 290, 501 02.
    • (1974) New England Journal of Medicine , vol.290 , pp. 501-02
    • McPherson, K.1
  • 35
    • 0032493079 scopus 로고    scopus 로고
    • Masked monitoring in clinical trials. Blind stupidity?
    • Meinert, C.L. (1998b) Masked monitoring in clinical trials. Blind stupidity?, New England Journal of Medicine, 338, 1381 2.
    • (1998) New England Journal of Medicine , vol.338 , pp. 1381-2
    • Meinert, C.L.1
  • 36
    • 0017744944 scopus 로고
    • Group sequential methods in the design and analysis of clinical trials
    • Pocock, S.J. (1977) Group sequential methods in the design and analysis of clinical trials, Biometrika, 64, 191 9.
    • (1977) Biometrika , vol.64 , pp. 191-9
    • Pocock, S.J.1
  • 37
    • 0027415674 scopus 로고
    • Data monitoring and interim analysis in the pharmaceutical industry: Ethical and logistical considerations
    • Rochold, F.W. Enas, G.G. (1993) Data monitoring and interim analysis in the pharmaceutical industry: ethical and logistical considerations, Statistics in Medicine, 12, 471 9.
    • (1993) Statistics in Medicine , vol.12 , pp. 471-9
    • Rochold, F.W.1    Enas, G.G.2
  • 38
    • 63849260553 scopus 로고
    • Remarks quoted in 'Discussion'
    • Simon, R. (1993) Remarks quoted in 'Discussion', Statistics in Medicine, 12, 521 5.
    • (1993) Statistics in Medicine , vol.12 , pp. 521-5
    • Simon, R.1
  • 40
    • 0030757475 scopus 로고    scopus 로고
    • Role of independent data-monitoring committees in randomized clinical trials sponsored by the National Cancer Institute
    • Smith, M.A., Ungerleider, R.S., Korn, E.L., Rubensteib, L. Simon, R. (1997) Role of independent data-monitoring committees in randomized clinical trials sponsored by the National Cancer Institute, Journal of Clinical Oncology, 14, 2736 43.
    • (1997) Journal of Clinical Oncology , vol.14 , pp. 2736-43
    • Smith, M.A.1    Ungerleider, R.S.2    Korn, E.L.3    Rubensteib, L.4    Simon, R.5
  • 41
    • 4544274355 scopus 로고    scopus 로고
    • Reported use of data monitoring committees in the main published reports of randomized controlled trials: A cross-sectional study
    • the DAMOCLES Group
    • Sydes, M.R., Altman, D.G., Babiker, A.B., Parmar, M.K.B., Spiegelhalter, D.J. the DAMOCLES Group 2004) Reported use of data monitoring committees in the main published reports of randomized controlled trials: a cross-sectional study, Clinical Trials, 1, 48 59.
    • (2004) Clinical Trials , vol.1 , pp. 48-59
    • Sydes, M.R.1    Altman, D.G.2    Babiker, A.B.3    Parmar, M.K.B.4    Spiegelhalter, D.J.5
  • 43
    • 34248548955 scopus 로고    scopus 로고
    • New clinical trials policy at FDA
    • Vastag, B. (2006) New clinical trials policy at FDA, Nature Biotechnology, 24, 1043.
    • (2006) Nature Biotechnology , vol.24 , pp. 1043
    • Vastag, B.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.