메뉴 건너뛰기




Volumn 10, Issue 2, 2013, Pages 225-235

Central statistical monitoring: Detecting fraud in clinical trials

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLINICAL TRIAL (TOPIC); FALSE POSITIVE RESULT; FRAUD; HUMAN; MONITORING; MULTICENTER STUDY (TOPIC); PRIORITY JOURNAL; VALIDATION STUDY;

EID: 84876537291     PISSN: 17407745     EISSN: 17407753     Source Type: Journal    
DOI: 10.1177/1740774512469312     Document Type: Article
Times cited : (35)

References (34)
  • 1
    • 40949130893 scopus 로고    scopus 로고
    • Ensuring trial validity by data quality assurance and diversification of monitoring methods
    • Baigent C, Harrell F, Buyse M, Emberson J, Altman D.. Ensuring trial validity by data quality assurance and diversification of monitoring methods. Clin Trials. 2008 ; 5: 49-55
    • (2008) Clin Trials , vol.5 , pp. 49-55
    • Baigent, C.1    Harrell, F.2    Buyse, M.3    Emberson, J.4    Altman, D.5
  • 2
    • 0033619940 scopus 로고    scopus 로고
    • The role of biostatistics in the prevention, detection and treatment of fraud in clinical trials
    • Buyse M, George S, Evans S, et al. The role of biostatistics in the prevention, detection and treatment of fraud in clinical trials. Stat Med. 1999 ; 18: 3435-51
    • (1999) Stat Med , vol.18 , pp. 3435-3451
    • Buyse, M.1    George, S.2    Evans, S.3
  • 3
    • 0030663540 scopus 로고    scopus 로고
    • Distinctions between fraud, bias, errors, misunderstanding, and incompetence
    • DeMets D.. Distinctions between fraud, bias, errors, misunderstanding, and incompetence. Clin Trials. 1997 ; 18: 637-50
    • (1997) Clin Trials , vol.18 , pp. 637-650
    • Demets, D.1
  • 4
    • 40949112288 scopus 로고    scopus 로고
    • Sensible approaches for reducing clinical trials costs
    • Eisenstein E, Collins R, Cracknell B, et al. Sensible approaches for reducing clinical trials costs. Clin Trials. 2008 ; 5: 75-84
    • (2008) Clin Trials , vol.5 , pp. 75-84
    • Eisenstein, E.1    Collins, R.2    Cracknell, B.3
  • 5
    • 0032189183 scopus 로고    scopus 로고
    • Guidelines for quality assurance in multicenter trials: A position paper
    • Knatterud G, Rockhold F, George S, et al. Guidelines for quality assurance in multicenter trials: A position paper. Control Clin Trials. 1998 ; 19: 477-93
    • (1998) Control Clin Trials , vol.19 , pp. 477-493
    • Knatterud, G.1    Rockhold, F.2    George, S.3
  • 6
    • 0026344087 scopus 로고
    • A case of data alteration in the Multiple Risk Factor Intervention Trial (MRFIT)
    • Neaton J, Bartsch G, Broste S, et al. A case of data alteration in the Multiple Risk Factor Intervention Trial (MRFIT). Control Clin Trials. 1991 ; 12: 731-40
    • (1991) Control Clin Trials , vol.12 , pp. 731-740
    • Neaton, J.1    Bartsch, G.2    Broste, S.3
  • 7
    • 0031080724 scopus 로고    scopus 로고
    • The trials of Dr. Bernard Fisher: A European perspective on an American episode
    • Peto R, Collins R, Sackett D, et al. The trials of Dr. Bernard Fisher: A European perspective on an American episode. Control Clin Trials. 1997 ; 18: 1-13
    • (1997) Control Clin Trials , vol.18 , pp. 1-13
    • Peto, R.1    Collins, R.2    Sackett, D.3
  • 8
    • 40949124713 scopus 로고    scopus 로고
    • Sensible guidelines for the conduct of large randomized trials
    • Yusuf S, Bosch J, Devereaux P, et al. Sensible guidelines for the conduct of large randomized trials. Clin Trials. 2008 ; 5: 38-39
    • (2008) Clin Trials , vol.5 , pp. 38-39
    • Yusuf, S.1    Bosch, J.2    Devereaux, P.3
  • 9
    • 79960284830 scopus 로고    scopus 로고
    • Monitoring the quality of conduct of clinical trials: A survey of current practices
    • Morrison B, Cochran C, White J, et al. Monitoring the quality of conduct of clinical trials: A survey of current practices. Clin Trials. 2011 ; 8: 342-49
    • (2011) Clin Trials , vol.8 , pp. 342-349
    • Morrison, B.1    Cochran, C.2    White, J.3
  • 10
    • 0024573650 scopus 로고
    • The role of data audits in detecting scientific misconduct: Results of the FDA program
    • Shapiro M, Charrow R.. The role of data audits in detecting scientific misconduct: Results of the FDA program. JAMA. 1989 ; 261: 2505-11
    • (1989) JAMA , vol.261 , pp. 2505-2511
    • Shapiro, M.1    Charrow, R.2
  • 11
    • 0027319878 scopus 로고
    • A successful system of scientific data audits for clinical trials: A report from the Cancer and Leukemia Group B
    • Weiss R, Vogelzang N, Peterson B, et al. A successful system of scientific data audits for clinical trials: A report from the Cancer and Leukemia Group B. JAMA. 1993 ; 270: 459-64
    • (1993) JAMA , vol.270 , pp. 459-464
    • Weiss, R.1    Vogelzang, N.2    Peterson, B.3
  • 13
    • 17844363698 scopus 로고    scopus 로고
    • Reducing the costs of phase III cardiovascular clinical trials
    • Eisenstein E, Lemons P, Tardiff B, et al. Reducing the costs of phase III cardiovascular clinical trials. Am Heart J. 2005 ; 149: 482-88
    • (2005) Am Heart J , vol.149 , pp. 482-488
    • Eisenstein, E.1    Lemons, P.2    Tardiff, B.3
  • 14
    • 0026330988 scopus 로고
    • Detecting fabrication of data in a multicenter collaborative animal study
    • Bailey K.. Detecting fabrication of data in a multicenter collaborative animal study. Control Clin Trials. 1991 ; 12: 741-52
    • (1991) Control Clin Trials , vol.12 , pp. 741-752
    • Bailey, K.1
  • 15
    • 0028866278 scopus 로고
    • The National Cancer Institute audit of the National Surgical Adjuvant Breast and Bowel Project B-06
    • Christian M, McCabe M, Korn E, et al. The National Cancer Institute audit of the National Surgical Adjuvant Breast and Bowel Project B-06. N Engl J Med. 1995 ; 333: 1469-74
    • (1995) N Engl J Med , vol.333 , pp. 1469-1474
    • Christian, M.1    McCabe, M.2    Korn, E.3
  • 16
    • 0033833235 scopus 로고    scopus 로고
    • Fraud in medical research: An international survey of biostatisticians
    • Ranstam J, Buyse M, George S, et al. Fraud in medical research: An international survey of biostatisticians. Control Clin Trials. 2000 ; 21: 415-27
    • (2000) Control Clin Trials , vol.21 , pp. 415-427
    • Ranstam, J.1    Buyse, M.2    George, S.3
  • 17
    • 85050788052 scopus 로고
    • Ethical problems in academic research
    • Swazey J, Anderson M, Lewis K.. Ethical problems in academic research. Am Sci. 1993 ; 81: 542-52
    • (1993) Am Sci , vol.81 , pp. 542-552
    • Swazey, J.1    Anderson, M.2    Lewis, K.3
  • 18
    • 23244440502 scopus 로고    scopus 로고
    • Suspected research fraud: Difficulties of getting the truth
    • White C.. Suspected research fraud: Difficulties of getting the truth. BMJ. 2005 ; 331: 281-88
    • (2005) BMJ , vol.331 , pp. 281-288
    • White, C.1
  • 19
    • 27644548513 scopus 로고    scopus 로고
    • Addition of clopidogrel to aspirin in 45852 patients with acute myocardial infarction: Randomized placebo-controlled trial
    • Addition of clopidogrel to aspirin in 45852 patients with acute myocardial infarction: Randomized placebo-controlled trial. Lancet. 2005 ; 366: 1607-21
    • (2005) Lancet , vol.366 , pp. 1607-1621
  • 20
    • 23244436762 scopus 로고    scopus 로고
    • Are these data real? Statistical methods for the detection of data fabrication in clinical trials
    • Al-Marzouki S, Evans S, Marshall T, Roberts I.. Are these data real? Statistical methods for the detection of data fabrication in clinical trials. BMJ. 2005 ; 331: 267-70
    • (2005) BMJ , vol.331 , pp. 267-270
    • Al-Marzouki, S.1    Evans, S.2    Marshall, T.3    Roberts, I.4
  • 21
    • 0030767941 scopus 로고    scopus 로고
    • European Stroke Prevention Study 2. Efficacy and safety data
    • European Stroke Prevention Study 2. Efficacy and safety data. J Neurol Sci. 1997 ; 151: S1 - S77
    • (1997) J Neurol Sci , vol.151
  • 24
    • 0033405536 scopus 로고    scopus 로고
    • Statistical quality control in clinical trials
    • Svolba G, Bauer P.. Statistical quality control in clinical trials. Control Clin Trials. 1999 ; 20: 519-30
    • (1999) Control Clin Trials , vol.20 , pp. 519-530
    • Svolba, G.1    Bauer, P.2
  • 25
    • 0036192135 scopus 로고    scopus 로고
    • Statistical techniques to detect fraud and other data irregularities in clinical questionnaire data
    • Taylor R, McEntegart D, Stillman E.. Statistical techniques to detect fraud and other data irregularities in clinical questionnaire data. Drug Inform J. 2002 ; 36: 115-25
    • (2002) Drug Inform J , vol.36 , pp. 115-125
    • Taylor, R.1    McEntegart, D.2    Stillman, E.3
  • 26
    • 44349168172 scopus 로고    scopus 로고
    • Effects of extended-release metoprolol succinate in patients undergoing non-cardiac surgery (POISE trial): A randomised controlled trial
    • Devereaux P, Yang H, Yusuf S, et al. Effects of extended-release metoprolol succinate in patients undergoing non-cardiac surgery (POISE trial): A randomised controlled trial. Lancet. 2008 ; 371: 1839-47
    • (2008) Lancet , vol.371 , pp. 1839-1847
    • Devereaux, P.1    Yang, H.2    Yusuf, S.3
  • 27
    • 0000956831 scopus 로고
    • The law of anomalous numbers
    • Benford F.. The law of anomalous numbers. Proc Am Phil Soc. 1938 ; 78: 551-72
    • (1938) Proc Am Phil Soc , vol.78 , pp. 551-572
    • Benford, F.1
  • 28
    • 0008586272 scopus 로고
    • Distribution of final digits in data
    • Preece D.. Distribution of final digits in data. Statistician. 1981 ; 30: 31-60
    • (1981) Statistician , vol.30 , pp. 31-60
    • Preece, D.1
  • 29
    • 84876580957 scopus 로고    scopus 로고
    • Cary, NC: ;
    • Cary, NC: ; 2002.
    • (2002)
  • 30
    • 2442682859 scopus 로고    scopus 로고
    • Presentation of multivariate data for clinical use: The Framingham Study risk score function
    • Sullivan L, Massaro J, D'Agostino R. Presentation of multivariate data for clinical use: The Framingham Study risk score function. Stat Med. 2004 ; 23: 1631-60
    • (2004) Stat Med , vol.23 , pp. 1631-1660
    • Sullivan, L.1    Massaro, J.2    D'Agostino, R.3
  • 31
  • 32
    • 0016128505 scopus 로고
    • Regression by leaps and bounds
    • Furnival G, Wilson R.. Regression by leaps and bounds. Technometrics. 1974 ; 16: 499-511
    • (1974) Technometrics , vol.16 , pp. 499-511
    • Furnival, G.1    Wilson, R.2
  • 34
    • 0034688194 scopus 로고    scopus 로고
    • Effect of an angiotensin-converting-enzyme inhibitor, ramipril on cardiovascular events in high-risk patients
    • Effect of an angiotensin-converting-enzyme inhibitor, ramipril on cardiovascular events in high-risk patients. N Engl J Med. 2000 ; 324: 145-53
    • (2000) N Engl J Med , vol.324 , pp. 145-153


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.