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Volumn 28, Issue 4, 2017, Pages 688-695

Statistical controversies in clinical research: Comparison of primary outcomes in protocols, public clinical-trial registries and publications: The example of oncology trials

Author keywords

Clinical trials; Methodology; Outcome reporting bias; Protocols

Indexed keywords

ARTICLE; CLINICAL PROTOCOL; CLINICAL RESEARCH; CLINICAL STUDY; COMPARATIVE STUDY; HUMAN; METHODOLOGY; ONCOLOGY; OUTCOME ASSESSMENT; PHASE 3 CLINICAL TRIAL (TOPIC); PRACTICE GUIDELINE; PRIORITY JOURNAL; PUBLICATION; QUALITY CONTROL; RANDOMIZED CONTROLLED TRIAL (TOPIC); REGISTER; SENSITIVITY AND SPECIFICITY; STATISTICAL ANALYSIS; STATISTICAL BIAS; MEDICAL RESEARCH; STANDARDS;

EID: 85019136519     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mdw682     Document Type: Article
Times cited : (17)

References (31)
  • 1
    • 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. Br Med J 2010; 340: c365.
    • (2010) Br Med J , vol.340
    • Kirkham, J.J.1    Dwan, K.M.2    Altman, D.G.3
  • 2
    • 84947290122 scopus 로고    scopus 로고
    • From protocols to publications: a study in selective reporting of outcomes in randomized trials in oncology
    • Raghav KP, Mahajan S, Yao JC et al. From protocols to publications: a study in selective reporting of outcomes in randomized trials in oncology. J Clin Oncol 2015; 33: 3583-3590.
    • (2015) J Clin Oncol , vol.33 , pp. 3583-3590
    • Raghav, K.P.1    Mahajan, S.2    Yao, J.C.3
  • 3
    • 84879803885 scopus 로고    scopus 로고
    • Systematic review of the empirical evidence of study publication bias and outcome reporting bias-an updated review
    • Dwan K, Gamble C, Williamson PR, Kirkham JJ. Systematic review of the empirical evidence of study publication bias and outcome reporting bias-an updated review. PLoS ONE 2013; 8: e66844.
    • (2013) PLoS ONE , vol.8
    • Dwan, K.1    Gamble, C.2    Williamson, P.R.3    Kirkham, J.J.4
  • 4
    • 69849092717 scopus 로고    scopus 로고
    • Comparison of registered and published primary outcomes in randomized controlled trials
    • Mathieu S, Boutron I, Moher D et al. Comparison of registered and published primary outcomes in randomized controlled trials. JAMA 2009; 302: 977-984.
    • (2009) JAMA , vol.302 , pp. 977-984
    • Mathieu, S.1    Boutron, I.2    Moher, D.3
  • 5
    • 0036179295 scopus 로고    scopus 로고
    • Statistical methodology of phase III cancer clinical trials: advances and future perspectives
    • Sylvester R, Van Glabbeke M, Collette L et al. Statistical methodology of phase III cancer clinical trials: advances and future perspectives. Eur J Cancer 2002; 38(Suppl 4): S162-S168.
    • (2002) Eur J Cancer , vol.38 , pp. S162-S168
    • Sylvester, R.1    Van Glabbeke, M.2    Collette, L.3
  • 6
    • 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, Chen EX. 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    Chen, E.X.4
  • 7
    • 56749097839 scopus 로고    scopus 로고
    • Bias, spin, and misreporting: time for full access to trial protocols and results
    • Chan AW. Bias, spin, and misreporting: time for full access to trial protocols and results. PLoS Med 2008; 5: e230.
    • (2008) PLoS Med , vol.5
    • Chan, A.W.1
  • 8
    • 4544223937 scopus 로고    scopus 로고
    • Clinical trial registration: a statement from the International Committee of Medical Journal Editors
    • DeAngelis CD, Drazen JM, Frizelle FA et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. JAMA 2004; 292: 1363-1364.
    • (2004) JAMA , vol.292 , pp. 1363-1364
    • DeAngelis, C.D.1    Drazen, J.M.2    Frizelle, F.A.3
  • 9
    • 84879598998 scopus 로고    scopus 로고
    • Trust but verify: trial registration and determining fidelity to the protocol
    • Zarin DA, Tse T. Trust but verify: trial registration and determining fidelity to the protocol. Ann Intern Med 2013; 159: 65-67.
    • (2013) Ann Intern Med , vol.159 , pp. 65-67
    • Zarin, D.A.1    Tse, T.2
  • 10
    • 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
  • 11
    • 84886948479 scopus 로고    scopus 로고
    • Cohort study of trials submitted to ethics committee identified discrepant reporting of outcomes in publications
    • Redmond S, von Elm E, Blumle A et al. Cohort study of trials submitted to ethics committee identified discrepant reporting of outcomes in publications. J Clin Epidemiol 2013; 66: 1367-1375.
    • (2013) J Clin Epidemiol , vol.66 , pp. 1367-1375
    • Redmond, S.1    von Elm, E.2    Blumle, A.3
  • 12
    • 84960384323 scopus 로고    scopus 로고
    • Comparison of registered and published outcomes in randomized controlled trials: a systematic review
    • Jones CW, Keil LG, Holland WC et al. Comparison of registered and published outcomes in randomized controlled trials: a systematic review. BMC Med 2015; 13: 282.
    • (2015) BMC Med , vol.13 , pp. 282
    • Jones, C.W.1    Keil, L.G.2    Holland, W.C.3
  • 13
    • 84886614481 scopus 로고    scopus 로고
    • Completeness of reporting of patient-relevant clinical trial outcomes: comparison of unpublished clinical study reports with publicly available data
    • Wieseler B, Wolfram N, McGauran N et al. Completeness of reporting of patient-relevant clinical trial outcomes: comparison of unpublished clinical study reports with publicly available data. PLoS Med 2013; 10: e1001526.
    • (2013) PLoS Med , vol.10
    • Wieseler, B.1    Wolfram, N.2    McGauran, N.3
  • 14
    • 84857127828 scopus 로고    scopus 로고
    • Impact of document type on reporting quality of clinical drug trials: a comparison of registry reports, clinical study reports, and journal publications
    • Wieseler B, Kerekes MF, Vervoelgyi V et al. Impact of document type on reporting quality of clinical drug trials: a comparison of registry reports, clinical study reports, and journal publications. Br Med J 2012; 344: d8141.
    • (2012) Br Med J , vol.344
    • Wieseler, B.1    Kerekes, M.F.2    Vervoelgyi, V.3
  • 15
    • 77950189829 scopus 로고    scopus 로고
    • CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials
    • Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. Br Med J 2010; 340: c332.
    • (2010) Br Med J , vol.340
    • Schulz, K.F.1    Altman, D.G.2    Moher, D.3
  • 16
    • 79952267051 scopus 로고    scopus 로고
    • The ClinicalTrials.gov results database-update and key issues
    • Zarin DA, Tse T, Williams RJ et al. The ClinicalTrials.gov results database-update and key issues. N Engl J Med 2011; 364: 852-860.
    • (2011) N Engl J Med , vol.364 , pp. 852-860
    • Zarin, D.A.1    Tse, T.2    Williams, R.J.3
  • 17
    • 84872080748 scopus 로고    scopus 로고
    • SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials
    • Chan AW, Tetzlaff JM, Gotzsche PC et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. Br Med J 2013; 346: e7586.
    • (2013) Br Med J , vol.346
    • Chan, A.W.1    Tetzlaff, J.M.2    Gotzsche, P.C.3
  • 18
    • 84929467361 scopus 로고    scopus 로고
    • Early versus delayed initiation of concurrent palliative oncology care: patient outcomes in the ENABLE III randomized controlled trial
    • Bakitas MA, Tosteson TD, Li Z et al. Early versus delayed initiation of concurrent palliative oncology care: patient outcomes in the ENABLE III randomized controlled trial. J Clin Oncol 2015; 33: 1438-1445.
    • (2015) J Clin Oncol , vol.33 , pp. 1438-1445
    • Bakitas, M.A.1    Tosteson, T.D.2    Li, Z.3
  • 19
    • 84905819846 scopus 로고    scopus 로고
    • Impact of brachytherapy on local recurrence rates after sublobar resection: results from ACOSOG Z4032 (Alliance), a phase III randomized trial for high-risk operable non-small-cell lung cancer
    • Fernando HC, Landreneau RJ, Mandrekar SJ et al. Impact of brachytherapy on local recurrence rates after sublobar resection: results from ACOSOG Z4032 (Alliance), a phase III randomized trial for high-risk operable non-small-cell lung cancer. J Clin Oncol 2014; 32: 2456-2462.
    • (2014) J Clin Oncol , vol.32 , pp. 2456-2462
    • Fernando, H.C.1    Landreneau, R.J.2    Mandrekar, S.J.3
  • 20
    • 67650831414 scopus 로고    scopus 로고
    • Reporting "basic results" in ClinicalTrials.gov
    • Tse T, Williams RJ, Zarin DA. Reporting "basic results" in ClinicalTrials.gov. Chest 2009; 136: 295-303.
    • (2009) Chest , vol.136 , pp. 295-303
    • Tse, T.1    Williams, R.J.2    Zarin, D.A.3
  • 21
    • 29544449337 scopus 로고    scopus 로고
    • Trial Registration at ClinicalTrials.gov between May and October 2005
    • Zarin DA, Tse T, Ide NC. Trial Registration at ClinicalTrials.gov between May and October 2005. N Engl J Med 2005; 353: 2779-2787.
    • (2005) N Engl J Med , vol.353 , pp. 2779-2787
    • Zarin, D.A.1    Tse, T.2    Ide, N.C.3
  • 22
    • 84864528623 scopus 로고    scopus 로고
    • The COMET (Core Outcome Measures in Effectiveness Trials) initiative: its role in improving cochrane reviews
    • Williamson P, Clarke M. The COMET (Core Outcome Measures in Effectiveness Trials) initiative: its role in improving cochrane reviews. Cochrane Database Syst Rev 2012; Ed000041.
    • (2012) Cochrane Database Syst Rev
    • Williamson, P.1    Clarke, M.2
  • 23
    • 33646489046 scopus 로고    scopus 로고
    • Research protocols: waiving confidentiality for the greater good
    • Chan AW, Upshur R, Singh JA et al. Research protocols: waiving confidentiality for the greater good. Br Med J 2006; 332: 1086-1089.
    • (2006) Br Med J , vol.332 , pp. 1086-1089
    • Chan, A.W.1    Upshur, R.2    Singh, J.A.3
  • 24
    • 84936880467 scopus 로고    scopus 로고
    • The most important tasks for peer reviewers evaluating a randomized controlled trial are not congruent with the tasks most often requested by journal editors
    • Chauvin A, Ravaud P, Baron G et al. The most important tasks for peer reviewers evaluating a randomized controlled trial are not congruent with the tasks most often requested by journal editors. BMC Med 2015; 13: 158.
    • (2015) BMC Med , vol.13 , pp. 158
    • Chauvin, A.1    Ravaud, P.2    Baron, G.3
  • 25
    • 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. Br Med J 2011; 342: c7153.
    • (2011) Br Med J , vol.342
    • Smyth, R.M.1    Kirkham, J.J.2    Jacoby, A.3
  • 26
    • 84936147067 scopus 로고    scopus 로고
    • Combined nivolumab and ipilimumab or monotherapy in untreated melanoma
    • Larkin J, Chiarion-Sileni V, Gonzalez R et al. Combined nivolumab and ipilimumab or monotherapy in untreated melanoma. N Engl J Med 2015; 373: 23-34.
    • (2015) N Engl J Med , vol.373 , pp. 23-34
    • Larkin, J.1    Chiarion-Sileni, V.2    Gonzalez, R.3
  • 27
    • 84907190038 scopus 로고    scopus 로고
    • Effect of routine assessment of specific psychosocial problems on personalized communication, counselors' awareness, and distress levels in cancer genetic counseling practice: a randomized controlled trial
    • Eijzenga W, Aaronson NK, Hahn DE et al. Effect of routine assessment of specific psychosocial problems on personalized communication, counselors' awareness, and distress levels in cancer genetic counseling practice: a randomized controlled trial. J Clin Oncol 2014; 32: 2998-3004.
    • (2014) J Clin Oncol , vol.32 , pp. 2998-3004
    • Eijzenga, W.1    Aaronson, N.K.2    Hahn, D.E.3
  • 28
    • 84897417340 scopus 로고    scopus 로고
    • Reporting discrepancies between the ClinicalTrials.gov results database and peer-reviewed publications
    • Hartung DM, Zarin DA, Guise JM et al. Reporting discrepancies between the ClinicalTrials.gov results database and peer-reviewed publications. Ann Intern Med 2014; 160: 477-483.
    • (2014) Ann Intern Med , vol.160 , pp. 477-483
    • Hartung, D.M.1    Zarin, D.A.2    Guise, J.M.3
  • 29
    • 84892584964 scopus 로고    scopus 로고
    • Timing and completeness of trial results posted at ClinicalTrials.gov and published in journals
    • discussion e1001566
    • Riveros C, Dechartres A, Perrodeau E et al. Timing and completeness of trial results posted at ClinicalTrials.gov and published in journals. PLoS Med 2013; 10: e1001566. discussion e1001566.
    • (2013) PLoS Med , vol.10
    • Riveros, C.1    Dechartres, A.2    Perrodeau, E.3
  • 31
    • 79960122013 scopus 로고    scopus 로고
    • New initiatives at Journal of Clinical Oncology
    • Cannistra SA. New initiatives at Journal of Clinical Oncology. J Clin Oncol 2011; 29: 2609-2610.
    • (2011) J Clin Oncol , vol.29 , pp. 2609-2610
    • Cannistra, S.A.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.