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Volumn 24, Issue 5, 2013, Pages 1238-1244

Bias in reporting of end points of efficacy and toxicity in randomized, clinical trials for women with breast cancer

Author keywords

Bias; Breast cancer; Clinical trials; Methodology

Indexed keywords

ALGORITHM; ARTICLE; BREAST CANCER; BREAST SURGERY; CANCER ADJUVANT THERAPY; CANCER RADIOTHERAPY; FUNDING; HUMAN; INFORMATION PROCESSING; JOURNAL IMPACT FACTOR; PRIORITY JOURNAL; QUANTITATIVE ANALYSIS; RANDOMIZED CONTROLLED TRIAL (TOPIC); SYSTEMATIC ERROR; SYSTEMIC THERAPY; THERAPY EFFECT;

EID: 84875139810     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mds636     Document Type: Article
Times cited : (97)

References (29)
  • 1
    • 78651320045 scopus 로고    scopus 로고
    • When are 'positive' clinical trials in oncology truly positive?
    • Ocana A, Tannock IF. When are 'positive' clinical trials in oncology truly positive?. J Natl Cancer Inst 2010; 103: 16-20.
    • (2010) J Natl Cancer Inst , vol.103 , pp. 16-20
    • Ocana, A.1    Tannock, I.F.2
  • 2
    • 52649129348 scopus 로고    scopus 로고
    • Systematic review of the empirical evidence of study publication bias and outcome reporting bias
    • Dwan K, Altman DG, Arnaiz JA et al. Systematic review of the empirical evidence of study publication bias and outcome reporting bias. PLoS One 2008; 3: e3081.
    • (2008) PLoS One , vol.3
    • Dwan, K.1    Altman, D.G.2    Arnaiz, J.A.3
  • 3
    • 2442692780 scopus 로고    scopus 로고
    • Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles
    • Chan AW, Hrobjartsson A, Haahr MT et al. Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles. JAMA 2004; 291: 2457-2465.
    • (2004) JAMA , vol.291 , pp. 2457-2465
    • Chan, A.W.1    Hrobjartsson, A.2    Haahr, M.T.3
  • 4
    • 79151476340 scopus 로고    scopus 로고
    • Bias due to changes in specified outcomes during the systematic review process
    • Kirkham JJ, Altman DG, Williamson PR. Bias due to changes in specified outcomes during the systematic review process. PLoS One 2010; 5: e9810.
    • (2010) PLoS One , vol.5
    • Kirkham, J.J.1    Altman, D.G.2    Williamson, P.R.3
  • 5
    • 70350517166 scopus 로고    scopus 로고
    • Adverse events in randomized trials: neglected, restricted, distorted, and silenced
    • Ioannidis JP. Adverse events in randomized trials: neglected, restricted, distorted, and silenced. Arch Intern Med 2009; 169: 1737-1739.
    • (2009) Arch Intern Med , vol.169 , pp. 1737-1739
    • Ioannidis, J.P.1
  • 6
    • 8744229000 scopus 로고    scopus 로고
    • Better reporting of harms in randomized trials: an extension of the CONSORT statement
    • Ioannidis JP, Evans SJ, Gotzsche PC et al. Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann Intern Med 2004; 141: 781-788.
    • (2004) Ann Intern Med , vol.141 , pp. 781-788
    • Ioannidis, J.P.1    Evans, S.J.2    Gotzsche, P.C.3
  • 8
    • 0037778772 scopus 로고    scopus 로고
    • Factors associated with failure to publish large randomized trials presented at an oncology meeting
    • Krzyzanowska MK, Pintilie M, Tannock IF. Factors associated with failure to publish large randomized trials presented at an oncology meeting. JAMA 2003; 290: 495-501.
    • (2003) JAMA , vol.290 , pp. 495-501
    • Krzyzanowska, M.K.1    Pintilie, M.2    Tannock, I.F.3
  • 9
    • 33846563409 scopus 로고    scopus 로고
    • Why most published research findings are false
    • Ioannidis JP. Why most published research findings are false. PLoS Med 2005; 2: e124.
    • (2005) PLoS Med , vol.2
    • Ioannidis, J.P.1
  • 10
    • 0037560389 scopus 로고    scopus 로고
    • Balancing benefits and harms in health care
    • Cuervo LG, Clarke M. Balancing benefits and harms in health care. BMJ 2003; 327: 65-66.
    • (2003) BMJ , vol.327 , pp. 65-66
    • Cuervo, L.G.1    Clarke, M.2
  • 11
    • 70350489859 scopus 로고    scopus 로고
    • Reporting of safety results in published reports of randomized controlled trials
    • Pitrou I, Boutron I, Ahmad N et al. Reporting of safety results in published reports of randomized controlled trials. Arch Intern Med 2009; 169: 1756-1761.
    • (2009) Arch Intern Med , vol.169 , pp. 1756-1761
    • Pitrou, I.1    Boutron, I.2    Ahmad, N.3
  • 12
    • 33847342187 scopus 로고    scopus 로고
    • Limitations are not properly acknowledged in the scientific literature
    • Ioannidis JP. Limitations are not properly acknowledged in the scientific literature. J Clin Epidemiol 2007; 60: 324-329.
    • (2007) J Clin Epidemiol , vol.60 , pp. 324-329
    • Ioannidis, J.P.1
  • 13
    • 0035515628 scopus 로고    scopus 로고
    • Family physicians' use of medical abstracts to guide decision making: style or substance?
    • Barry HC, Ebell MH, Shaughnessy AF et al. Family physicians' use of medical abstracts to guide decision making: style or substance?. J Am Board Fam Pract 2001; 14: 437-442.
    • (2001) J Am Board Fam Pract , vol.14 , pp. 437-442
    • Barry, H.C.1    Ebell, M.H.2    Shaughnessy, A.F.3
  • 14
    • 0025681857 scopus 로고
    • Indexes and boundaries for 'quantitative significance' in statistical decisions
    • Burnand B, Kernan WN, Feinstein AR. Indexes and boundaries for 'quantitative significance' in statistical decisions. J Clin Epidemiol 1990; 43: 1273-1284.
    • (1990) J Clin Epidemiol , vol.43 , pp. 1273-1284
    • Burnand, B.1    Kernan, W.N.2    Feinstein, A.R.3
  • 15
    • 75149145066 scopus 로고    scopus 로고
    • Neoadjuvant chemotherapy with trastuzumab followed by adjuvant trastuzumab versus neoadjuvant chemotherapy alone, in patients with HER2-positive locally advanced breast cancer (the NOAH trial): a randomised controlled superiority trial with a parallel HER2-negative cohort
    • Gianni L, Eiermann W, Semiglazov V et al. Neoadjuvant chemotherapy with trastuzumab followed by adjuvant trastuzumab versus neoadjuvant chemotherapy alone, in patients with HER2-positive locally advanced breast cancer (the NOAH trial): a randomised controlled superiority trial with a parallel HER2-negative cohort. Lancet 2010; 375: 377-384.
    • (2010) Lancet , vol.375 , pp. 377-384
    • Gianni, L.1    Eiermann, W.2    Semiglazov, V.3
  • 16
    • 79952487463 scopus 로고    scopus 로고
    • Eribulin monotherapy versus treatment of physician's choice in patients with metastatic breast cancer (EMBRACE): a phase 3 open-label randomised study
    • Cortes J, O'Shaughnessy J, Loesch D et al. Eribulin monotherapy versus treatment of physician's choice in patients with metastatic breast cancer (EMBRACE): a phase 3 open-label randomised study. Lancet 2011; 377: 914-923.
    • (2011) Lancet , vol.377 , pp. 914-923
    • Cortes, J.1    O'Shaughnessy, J.2    Loesch, D.3
  • 17
    • 78649732579 scopus 로고    scopus 로고
    • Adjuvant docetaxel for high-risk, nodenegative breast cancer
    • Martin M, Segui MA, Anton A et al. Adjuvant docetaxel for high-risk, nodenegative breast cancer. N Engl J Med 2010; 363: 2200-2210.
    • (2010) N Engl J Med , vol.363 , pp. 2200-2210
    • Martin, M.1    Segui, M.A.2    Anton, A.3
  • 18
    • 77949680683 scopus 로고    scopus 로고
    • The impact of outcome reporting bias in randomised controlled trials on a cohort of systematic reviews
    • Kirkham JJ, Dwan KM, Altman DG et al. The impact of outcome reporting bias in randomised controlled trials on a cohort of systematic reviews. BMJ 2010; 340: c365.
    • (2010) BMJ , vol.340
    • Kirkham, J.J.1    Dwan, K.M.2    Altman, D.G.3
  • 19
    • 77952787734 scopus 로고    scopus 로고
    • Reporting and interpretation of randomized controlled trials with statistically nonsignificant results for primary outcomes
    • Boutron I, Dutton S, Ravaud P et al. Reporting and interpretation of randomized controlled trials with statistically nonsignificant results for primary outcomes. JAMA 2010; 303: 2058-2064.
    • (2010) JAMA , vol.303 , pp. 2058-2064
    • Boutron, I.1    Dutton, S.2    Ravaud, P.3
  • 20
    • 78751697239 scopus 로고    scopus 로고
    • Frequency and reasons for outcome reporting bias in clinical trials: interviews with trialists
    • Smyth RM, Kirkham JJ, Jacoby A et al. Frequency and reasons for outcome reporting bias in clinical trials: interviews with trialists. BMJ 2011; 342: c7153.
    • (2011) BMJ , vol.342
    • Smyth, R.M.1    Kirkham, J.J.2    Jacoby, A.3
  • 21
    • 56749166123 scopus 로고    scopus 로고
    • Reporting bias in drug trials submitted to the Food and Drug Administration: review of publication and presentation
    • discussion e217.
    • Rising K, Bacchetti P, Bero L. Reporting bias in drug trials submitted to the Food and Drug Administration: review of publication and presentation. PLoS Med 2008; 5: e217; discussion e217.
    • (2008) PLoS Med , vol.5
    • Rising, K.1    Bacchetti, P.2    Bero, L.3
  • 22
    • 80051580618 scopus 로고    scopus 로고
    • Cancer statistics, 2011: the impact of eliminating socioeconomic and racial disparities on premature cancer deaths
    • Siegel R, Ward E, Brawley O et al. Cancer statistics, 2011: the impact of eliminating socioeconomic and racial disparities on premature cancer deaths. CA Cancer J Clin 2011; 61: 212-236.
    • (2011) CA Cancer J Clin , vol.61 , pp. 212-236
    • Siegel, R.1    Ward, E.2    Brawley, O.3
  • 23
    • 47749118439 scopus 로고    scopus 로고
    • Endpoints for assessing drug activity in clinical trials
    • Pazdur R. Endpoints for assessing drug activity in clinical trials. Oncologist 2008; 13(Suppl 2): 19-21.
    • (2008) Oncologist , vol.13 , Issue.SUPPL. 2 , pp. 19-21
    • Pazdur, R.1
  • 24
    • 84860496547 scopus 로고    scopus 로고
    • Progression-free survival: meaningful or simply measurable?
    • Booth CM, Eisenhauer EA. Progression-free survival: meaningful or simply measurable?. J Clin Oncol 2012; 30(10): 1030-1033.
    • (2012) J Clin Oncol , vol.30 , Issue.10 , pp. 1030-1033
    • Booth, C.M.1    Eisenhauer, E.A.2
  • 25
    • 78651320045 scopus 로고    scopus 로고
    • When are 'positive' clinical trials in oncology truly positive?
    • Ocana A, Tannock IF. When are 'positive' clinical trials in oncology truly positive?. J Natl Cancer Inst 2011; 103: 16-20.
    • (2011) J Natl Cancer Inst , vol.103 , pp. 16-20
    • Ocana, A.1    Tannock, I.F.2
  • 26
    • 84856229186 scopus 로고    scopus 로고
    • Poor correlation between progression-free and overall survival in modern clinical trials: are composite endpoints the answer?
    • Amir E, Seruga B, Kwong R, Tannock IF, Ocaña A. Poor correlation between progression-free and overall survival in modern clinical trials: are composite endpoints the answer?. Eur J Cancer 2012; 48(3): 385-388.
    • (2012) Eur J Cancer , vol.48 , Issue.3 , pp. 385-388
    • Amir, E.1    Seruga, B.2    Kwong, R.3    Tannock, I.F.4    Ocaña, A.5
  • 27
    • 84855595256 scopus 로고    scopus 로고
    • Consistency in the analysis and reporting of primary end points in oncology randomized controlled trials from registration to publication: a systematic review
    • You B, Gan HK, Pond G et al. Consistency in the analysis and reporting of primary end points in oncology randomized controlled trials from registration to publication: a systematic review. J Clin Oncol 2012; 30: 210-216.
    • (2012) J Clin Oncol , vol.30 , pp. 210-216
    • You, B.1    Gan, H.K.2    Pond, G.3
  • 28
    • 84877120815 scopus 로고    scopus 로고
    • (16 March, date last accessed)
    • http://clinicaltrials.gov/ct2/info/about. (16 March 2012, date last accessed).
    • (2012)
  • 29
    • 84877132374 scopus 로고    scopus 로고
    • (16 March, date last accessed)
    • https://www.clinicaltrialsregister.eu/. (16 March 2012, date last accessed).
    • (2012)


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