메뉴 건너뛰기




Volumn 10, Issue 5, 2015, Pages

Terminated trials in the clinicaltrials.gov results database: Evaluation of availability of primary outcome data and reasons for termination

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL PRODUCT;

EID: 84960360308     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0127242     Document Type: Article
Times cited : (151)

References (41)
  • 1
    • 23444434093 scopus 로고
    • European society of cardiology the early termination of clinical trials: Causes, consequences, and control
    • PMID: 8205706
    • Task Force of the Working Group on Arrhythmias of the European Society of Cardiology. The early termination of clinical trials: causes, consequences, and control. With special reference to trials in the field of arrhythmias and sudden death. Circulation. 1994; 89(6):2892-907. PMID: 8205706
    • (1994) With Special Reference to Trials in the Field of Arrhythmias and Sudden Death , vol.89 , Issue.6 , pp. 2892-2907
  • 2
    • 77949879943 scopus 로고    scopus 로고
    • Stopping randomized trials early for benefit and estimation of treatment effects: Systematic review and meta-regression analysis
    • PMID: 20332404
    • Bassler D, Briel M, Montori VM, Lane M, Glasziou P, Zhou Q, et al. Stopping randomized trials early for benefit and estimation of treatment effects: systematic review and meta-regression analysis. Jama. 2010; 303(12):1180-7. doi: 10.1001/jama.2010.310 PMID: 20332404
    • (2010) Jama , vol.303 , Issue.12 , pp. 1180-1187
    • Bassler, D.1    Briel, M.2    Montori, V.M.3    Lane, M.4    Glasziou, P.5    Zhou, Q.6
  • 3
    • 79952503735 scopus 로고    scopus 로고
    • Inefficacy interim monitoring procedures in randomized clinical trials: The need to report
    • PMID: 21400374
    • Korn EL, Freidlin B. Inefficacy interim monitoring procedures in randomized clinical trials: the need to report. Am J Bioeth. 2011; 11(3):2-10. doi: 10.1080/15265161.2010.546471 PMID: 21400374
    • (2011) Am J Bioeth , vol.11 , Issue.3 , pp. 2-10
    • Korn, E.L.1    Freidlin, B.2
  • 4
    • 79957846225 scopus 로고    scopus 로고
    • Early stopping of clinical trials: Charting the ethical terrain
    • PMID: 21598846
    • Malmqvist E, Juth N, Lynoe N, Helgesson G. Early stopping of clinical trials: charting the ethical terrain. Kennedy Inst Ethics J. 2011; 21(1):51-78. PMID: 21598846
    • (2011) Kennedy Inst Ethics J , vol.21 , Issue.1 , pp. 51-78
    • Malmqvist, E.1    Juth, N.2    Lynoe, N.3    Helgesson, G.4
  • 5
    • 27644487803 scopus 로고    scopus 로고
    • Randomized trials stopped early for benefit: A systematic review
    • PMID: 16264162
    • Montori VM, Devereaux PJ, Adhikari NK, Burns KE, Eggert CH, Briel M, et al. Randomized trials stopped early for benefit: a systematic review. Jama. 2005; 294(17):2203-9. PMID: 16264162
    • (2005) Jama , vol.294 , Issue.17 , pp. 2203-2209
    • Montori, V.M.1    Devereaux, P.J.2    Adhikari, N.K.3    Burns, K.E.4    Eggert, C.H.5    Briel, M.6
  • 6
    • 0037514264 scopus 로고    scopus 로고
    • Stopping medical research to save money: A broken pact with researchers and patients
    • PMID: 12709471
    • Psaty BM, Rennie D. Stopping medical research to save money: a broken pact with researchers and patients. Jama. 2003; 289(16):2128-31. PMID: 12709471
    • (2003) Jama , vol.289 , Issue.16 , pp. 2128-2131
    • Psaty, B.M.1    Rennie, D.2
  • 8
    • 79951898822 scopus 로고    scopus 로고
    • Accrual experience of national cancer institute cooperative group phase III trials activated from 2000 to 2007
    • PMID: 21060029
    • Korn EL, Freidlin B, Mooney M, Abrams JS. Accrual experience of National Cancer Institute Cooperative Group phase III trials activated from 2000 to 2007. J Clin Oncol. 2010; 28(35):5197-201. doi: 10. 1200/JCO.2010.31.5382 PMID: 21060029
    • (2010) J Clin Oncol , vol.28 , Issue.35 , pp. 5197-5201
    • Korn, E.L.1    Freidlin, B.2    Mooney, M.3    Abrams, J.S.4
  • 9
    • 84905121663 scopus 로고    scopus 로고
    • Prevalence, characteristics, and predictors of early termination of cardiovascular clinical trials due to low recruitment: Insights from the ClinicalTrials.gov registry
    • PMID: 25066561
    • Bernardez-Pereira S, Lopes RD, Carrion MJM, Santucci EV, Soares RM, de Oliveira Abreu M, et al. Prevalence, characteristics, and predictors of early termination of cardiovascular clinical trials due to low recruitment: Insights from the ClinicalTrials.gov registry. American Heart Journal. 2014; 168-(2):213-9. doi: 10.1016/j.ahj.2014.04.013 PMID: 25066561
    • (2014) American Heart Journal , vol.168 , Issue.2 , pp. 213-219
    • Bernardez-Pereira, S.1    Lopes, R.D.2    Carrion, M.J.M.3    Santucci, E.V.4    Soares, R.M.5    De Oliveira Abreu, M.6
  • 10
    • 84915829316 scopus 로고    scopus 로고
    • Discontinuation and non-publication of surgical randomised controlled trials: Observational study
    • PMID: 25491195
    • Chapman SJ, Shelton B, Mahmood H, Fitzgerald JE, Harrison EM, Bhangu A. Discontinuation and non-publication of surgical randomised controlled trials: observational study. BMJ. 2014; 349:g6870. doi: 10.1136/bmj.g6870 PMID: 25491195
    • (2014) BMJ , vol.349 , pp. g6870
    • Chapman, S.J.1    Shelton, B.2    Mahmood, H.3    Fitzgerald, J.E.4    Harrison, E.M.5    Bhangu, A.6
  • 11
    • 80255123795 scopus 로고    scopus 로고
    • The prevalence and economic impact of low-enrolling clinical studies at an academic medical center
    • ACM PMID: 21952064
    • Kitterman DR, Cheng SK, Dilts DM, Orwoll ES. The prevalence and economic impact of low-enrolling clinical studies at an academic medical center. Acad Med. 2011; 86(11):1360-6. doi: 10.1097/ACM.0b013e3182306440 PMID: 21952064
    • (2011) Acad Med , vol.86 , Issue.11 , pp. 1360-1366
    • Kitterman, D.R.1    Cheng, S.K.2    Dilts, D.M.3    Orwoll, E.S.4
  • 12
    • 84960441623 scopus 로고    scopus 로고
    • Characteristics and Causes for Non-Accrued Clinical Research (NACR) at an Academic Medical Institution
    • PMID: 23671544
    • Tice DG, Carroll KA, Bhatt KH, Belknap SM, Mai D, Gipson HJ, et al. Characteristics and Causes for Non-Accrued Clinical Research (NACR) at an Academic Medical Institution. J Clin Med Res. 2013; 5-(3):185-93. doi: 10.4021/jocmr1320w PMID: 23671544
    • (2013) J Clin Med Res , vol.5 , Issue.3 , pp. 185-193
    • Tice, D.G.1    Carroll, K.A.2    Bhatt, K.H.3    Belknap, S.M.4    Mai, D.5    Gipson, H.J.6
  • 13
    • 84922361374 scopus 로고    scopus 로고
    • Unsuccessful trial accrual and human subjects protections: An empirical analysis of recently closed trials
    • PMID: 25475878
    • Carlisle B, Kimmelman J, Ramsay T, MacKinnon N. Unsuccessful trial accrual and human subjects protections: An empirical analysis of recently closed trials. Clin Trials. 2015; 12(1):77-83. doi: 10.1177/1740774514558307 PMID: 25475878
    • (2015) Clin Trials , vol.12 , Issue.1 , pp. 77-83
    • Carlisle, B.1    Kimmelman, J.2    Ramsay, T.3    MacKinnon, N.4
  • 14
    • 84896800584 scopus 로고    scopus 로고
    • Prevalence, characteristics, and publication of discontinued randomized trials
    • PMID: 24618966
    • Kasenda B, von Elm E, You J, Blumle A, Tomonaga Y, Saccilotto R, et al. Prevalence, characteristics, and publication of discontinued randomized trials. Jama. 2014; 311(10):1045-51. doi: 10.1001/jama. 2014.1361 PMID: 24618966
    • (2014) Jama , vol.311 , Issue.10 , pp. 1045-1051
    • Kasenda, B.1    Von Elm, E.2    You, J.3    Blumle, A.4    Tomonaga, Y.5    Saccilotto, R.6
  • 15
    • 84960328649 scopus 로고    scopus 로고
    • Food and Drug Administration Amendments Act of 2007
    • 110-85, Title VIII-Clinical Trial Databases, 121 STAT. 904 Sept. 27
    • Food and Drug Administration Amendments Act of 2007. Pub. L. 110-85, Title VIII-Clinical Trial Databases, 121 STAT. 904 (Sept. 27, 2007). Available: http://www.gpo.gov/fdsys/pkg/PLAW-110publ85/ pdf/PLAW-110publ85.pdf#page=82.
    • (2007) Publ
  • 16
    • 84960461357 scopus 로고    scopus 로고
    • ClinicalTrials.gov Frequently asked questions: How do I submit results information if the trial is terminated (that is, stopped prematurely) and no data were collected for one or more Outcome Measures?
    • Internet Bethesda (MD): National Library of Medicine (US) updated 2015Feb 6 March
    • ClinicalTrials.gov Frequently asked questions: How do I submit results information if the trial is terminated (that is, stopped prematurely) and no data were collected for one or more Outcome Measures? [Internet]. Bethesda (MD): National Library of Medicine (US), National Center for Biomedical Information. [updated 2015 Feb]. Available: https://clinicaltrials.gov/ct2/manage-recs/faq#terminated. Accessed 6 March 2015.
    • (2015) National Center for Biomedical Information
  • 17
    • 84960374007 scopus 로고    scopus 로고
    • ClinicalTrials.gov Protocol data element definitions (draft)
    • Internet Bethesda (MD): National Library of Medicine (US) updated 2014Sep 6 March
    • ClinicalTrials.gov Protocol data element definitions (draft). [Internet]. Bethesda (MD): National Library of Medicine (US), National Center for Biomedical Information. [updated 2014 Sep]. Available: http:// prsinfo.clinicaltrials.gov/definitions.html. Accessed 6 March 2015.
    • (2015) National Center for Biomedical Information
  • 18
    • 84960428245 scopus 로고    scopus 로고
    • ClinicalTrials.gov "Basic Results" data element definitions (draft)
    • Internet Bethesda (MD): National Library of Medicine (US) 2014Sep 6 March
    • ClinicalTrials.gov "Basic Results" data element definitions (draft). [Internet]. Bethesda (MD): National Library of Medicine (US), National Center for Biomedical Information. [updated 2014 Sep]. Available: http://prsinfo.clinicaltrials.gov/results-definitions.html. Accessed 6 March 2015.
    • (2015) National Center for Biomedical Information
  • 19
    • 34248527890 scopus 로고    scopus 로고
    • Issues in the registration of clinical trials
    • PMID: 17507347
    • Zarin DA, Ide NC, Tse T, Harlan WR, West JC, Lindberg DA. Issues in the registration of clinical trials. Jama. 2007; 297(19):2112-20. PMID: 17507347
    • (2007) Jama , vol.297 , Issue.19 , pp. 2112-2120
    • Zarin, D.A.1    Ide, N.C.2    Tse, T.3    Harlan, W.R.4    West, J.C.5    Lindberg, D.A.6
  • 20
    • 67650802527 scopus 로고    scopus 로고
    • Update on registration of clinical trials in clinicaltrials.gov
    • PMID: 19584213
    • Tse T, Williams RJ, Zarin DA. Update on Registration of Clinical Trials in ClinicalTrials.gov. Chest. 2009; 136(1):304-5. doi: 10.1378/chest.09-1219 PMID: 19584213
    • (2009) Chest , vol.136 , Issue.1 , pp. 304-305
    • Tse, T.1    Williams, R.J.2    Zarin, D.A.3
  • 21
    • 67650831414 scopus 로고    scopus 로고
    • Reporting "basic results" in ClinicalTrials.gov
    • PMID: 19584212
    • Tse T, Williams RJ, Zarin DA. Reporting "basic results" in ClinicalTrials.gov. Chest. 2009; 136 (1):295-303. doi: 10.1378/chest.08-3022 PMID: 19584212
    • (2009) Chest , vol.136 , Issue.1 , pp. 295-303
    • Tse, T.1    Williams, R.J.2    Zarin, D.A.3
  • 22
    • 79952267051 scopus 로고    scopus 로고
    • The ClinicalTrials.gov results database-update and key issues
    • PMID: 21366476
    • Zarin DA, Tse T, Williams RJ, Califf RM, Ide NC. The ClinicalTrials.gov results database-update and key issues. N Engl J Med. 2011; 364(9):852-60. doi: 10.1056/NEJMsa1012065 PMID: 21366476
    • (2011) N Engl J Med , vol.364 , Issue.9 , pp. 852-860
    • Zarin, D.A.1    Tse, T.2    Williams, R.J.3    Califf, R.M.4    Ide, N.C.5
  • 23
    • 84855461394 scopus 로고    scopus 로고
    • Achieving sufficient accrual to address the primary endpoint in phase III clinical trials from U.S cooperative oncology groups
    • PMID: 21976533
    • Schroen AT, Petroni GR, Wang H, Thielen MJ, Gray R, Benedetti J, et al. Achieving sufficient accrual to address the primary endpoint in phase III clinical trials from U.S. Cooperative Oncology Groups. Clin Cancer Res. 2012; 18(1):256-62. doi: 10.1158/1078-0432.CCR-11-1633 PMID: 21976533
    • (2012) Clin Cancer Res , vol.18 , Issue.1 , pp. 256-262
    • Schroen, A.T.1    Petroni, G.R.2    Wang, H.3    Thielen, M.J.4    Gray, R.5    Benedetti, J.6
  • 24
    • 84960328355 scopus 로고    scopus 로고
    • Results and registration for: Rituximab for the Treatment of Early Rheumatoid Arthritis (RA)
    • Internet Bethesda (MD): National Library of Medicine (US), National Center for Biomedical Information. 2000- first received 6 Nov 2006; results first received 11 Oct2012 6 March
    • National Institute of Allergy and Infectious Diseases (NIAID). Results and registration for: Rituximab for the Treatment of Early Rheumatoid Arthritis (RA). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US), National Center for Biomedical Information. 2000- [first received 6 Nov 2006; results first received 11 Oct 2012]. Available: https://clinicaltrials.gov/show/NCT00396812. Accessed 6 March 2015.
    • (2015) ClinicalTrials.gov
    • National Institute of Allergy and Infectious Diseases (NIAID)1
  • 25
    • 84862955602 scopus 로고    scopus 로고
    • Publication of NIH funded trials registered in ClinicalTrials.gov: Cross sectional analysis
    • PMID: 22214755
    • Ross JS, Tse T, Zarin DA, Xu H, Zhou L, Krumholz HM. Publication of NIH funded trials registered in ClinicalTrials.gov: cross sectional analysis. BMJ. 2012; 344:d7292. doi: 10.1136/bmj.d7292 PMID: 22214755
    • (2012) BMJ , vol.344 , pp. d7292
    • Ross, J.S.1    Tse, T.2    Zarin, D.A.3    Xu, H.4    Zhou, L.5    Krumholz, H.M.6
  • 26
    • 84960362122 scopus 로고    scopus 로고
    • Internet Bethesda (MD): National Library of Medicine (US); 2003 Oct 30 [updated 21 Feb2014] 6 March
    • Clinical Trial Registry Numbers in MEDLINE(R)/PubMed(R) Records. [Internet]. Bethesda (MD): National Library of Medicine (US); 2003 Oct 30 [updated 21 Feb 2014]. Available: www.nlm.nih.gov/bsd/ policy/clin-trials.html. Accessed 6 March 2015.
    • (2015) Clinical Trial Registry Numbers in MEDLINE(R)/PubMed(R) Records
  • 28
    • 84860444921 scopus 로고    scopus 로고
    • Characteristics of clinical trials registered in clinicaltrials.gov, 2007-2010
    • PMID: 22550198
    • Califf RM, Zarin DA, Kramer JM, Sherman RE, Aberle LH, Tasneem A. Characteristics of clinical trials registered in ClinicalTrials.gov, 2007-2010. Jama. 2012; 307(17):1838-47. doi: 10.1001/jama.2012.3424 PMID: 22550198
    • (2012) Jama , vol.307 , Issue.17 , pp. 1838-1847
    • Califf, R.M.1    Zarin, D.A.2    Kramer, J.M.3    Sherman, R.E.4    Aberle, L.H.5    Tasneem, A.6
  • 29
    • 33744981438 scopus 로고    scopus 로고
    • What influences recruitment to randomised controlled trials? A review of trials funded by two UK funding agencies
    • PMID: 16603070
    • McDonald AM, Knight RC, Campbell MK, Entwistle VA, Grant AM, Cook JA, et al. What influences recruitment to randomised controlled trials? A review of trials funded by two UK funding agencies. Trials. 2006; 7:9. PMID: 16603070
    • (2006) Trials , vol.7 , pp. 9
    • McDonald, A.M.1    Knight, R.C.2    Campbell, M.K.3    Entwistle, V.A.4    Grant, A.M.5    Cook, J.A.6
  • 30
    • 84896260691 scopus 로고    scopus 로고
    • The National Cancer Institute-American Society of Clinical Oncology Cancer Trial Accrual Symposium: Summary and recommendations
    • PMID: 24130252
    • Denicoff AM, McCaskill-Stevens W, Grubbs SS, Bruinooge SS, Comis RL, Devine P, et al. The National Cancer Institute-American Society of Clinical Oncology Cancer Trial Accrual Symposium: summary and recommendations. J Oncol Pract. 2013; 9(6):267-76. doi: 10.1200/JOP.2013.001119 PMID: 24130252
    • (2013) J Oncol Pract , vol.9 , Issue.6 , pp. 267-276
    • Denicoff, A.M.1    McCaskill-Stevens, W.2    Grubbs, S.S.3    Bruinooge, S.S.4    Comis, R.L.5    Devine, P.6
  • 31
    • 84915757902 scopus 로고    scopus 로고
    • Clinical trials: What a waste
    • PMID: 25499097
    • Ioannidis JP. Clinical trials: what a waste. BMJ. 2014; 349:g7089. doi: 10.1136/bmj.g7089 PMID: 25499097
    • (2014) BMJ , vol.349 , pp. g7089
    • Ioannidis, J.P.1
  • 32
    • 4844223081 scopus 로고    scopus 로고
    • Outcome reporting bias in randomized trials funded by the canadian institutes of health research
    • PMID: 15451835
    • Chan AW, Krleza-Jeric K, Schmid I, Altman DG. Outcome reporting bias in randomized trials funded by the Canadian Institutes of Health Research. Cmaj. 2004; 171(7):735-40. PMID: 15451835
    • (2004) Cmaj , vol.171 , Issue.7 , pp. 735-740
    • Chan, A.W.1    Krleza-Jeric, K.2    Schmid, I.3    Altman, D.G.4
  • 33
    • 0025794172 scopus 로고
    • Publication bias in clinical research
    • PMID: 1672966
    • Easterbrook PJ, Berlin JA, Gopalan R, Matthews DR. Publication bias in clinical research. Lancet. 1991; 337(8746):867-72. PMID: 1672966
    • (1991) Lancet , vol.337 , Issue.8746 , pp. 867-872
    • Easterbrook, P.J.1    Berlin, J.A.2    Gopalan, R.3    Matthews, D.R.4
  • 35
    • 54749152234 scopus 로고    scopus 로고
    • Publication of clinical trials supporting successful new drug applications: A literature analysis
    • PMID: 18816163
    • Lee K, Bacchetti P, Sim I. Publication of clinical trials supporting successful new drug applications: a literature analysis. PLoS Med. 2008; 5(9):e191. doi: 10.1371/journal.pmed.0050191 PMID: 18816163
    • (2008) PLoS Med , vol.5 , Issue.9 , pp. e191
    • Lee, K.1    Bacchetti, P.2    Sim, I.3
  • 36
    • 38349049478 scopus 로고    scopus 로고
    • Selective publication of antidepressant trials and its influence on apparent efficacy
    • PMID: 18199864
    • Turner EH, Matthews AM, Linardatos E, Tell RA, Rosenthal R. Selective publication of antidepressant trials and its influence on apparent efficacy. The New England journal of medicine. 2008; 358 (3):252-60. doi: 10.1056/NEJMsa065779 PMID: 18199864
    • (2008) The New England Journal of Medicine , vol.358 , Issue.3 , pp. 252-260
    • Turner, E.H.1    Matthews, A.M.2    Linardatos, E.3    Tell, R.A.4    Rosenthal, R.5
  • 37
    • 84897417340 scopus 로고    scopus 로고
    • Reporting discrepancies between the ClinicalTrials.gov results database and peer-reviewed publications
    • PMID: 24687070
    • Hartung DM, Zarin DA, Guise JM, McDonagh M, Paynter R, Helfand M. Reporting discrepancies between the ClinicalTrials.gov results database and peer-reviewed publications. Ann Intern Med. 2014; 160(7):477-83. doi: 10.7326/M13-0480 PMID: 24687070
    • (2014) Ann Intern Med , vol.160 , Issue.7 , pp. 477-483
    • Hartung, D.M.1    Zarin, D.A.2    Guise, J.M.3    McDonagh, M.4    Paynter, R.5    Helfand, M.6
  • 38
    • 84896759357 scopus 로고    scopus 로고
    • Reporting of results in clinicaltrials.gov and Highimpact
    • PMID: 24618969
    • Becker JE, Krumholz HM, Ben-Josef G, Ross JS. Reporting of results in ClinicalTrials.gov and highimpact journals. Jama. 2014; 311(10):1063-5. doi: 10.1001/jama.2013.285634 PMID: 24618969
    • (2014) Journals Jama , vol.311 , Issue.10 , pp. 1063-1065
    • Becker, J.E.1    Krumholz, H.M.2    Ben-Josef, G.3    Ross, J.S.4
  • 39
    • 84892584964 scopus 로고    scopus 로고
    • Timing and completeness of trial results posted at clinicaltrials.gov and Published in Journals
    • discussion e PMID: 24311990
    • Riveros C, Dechartres A, Perrodeau E, Haneef R, Boutron I, Ravaud P. Timing and completeness of trial results posted at ClinicalTrials.gov and published in journals. PLoS Med. 2013; 10(12):e1001566; discussion e. doi: 10.1371/journal.pmed.1001566 PMID: 24311990
    • (2013) PLoS Med , vol.10 , Issue.12 , pp. e1001566
    • Riveros, C.1    Dechartres, A.2    Perrodeau, E.3    Haneef, R.4    Boutron, I.5    Ravaud, P.6
  • 40
    • 77950273246 scopus 로고    scopus 로고
    • CONSORT 2010 explanation and elaboration: Updated guidelines for reporting parallel group randomised trials
    • PMID: 20332511
    • Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010; 340:c869. doi: 10.1136/bmj.c869 PMID: 20332511
    • BMJ , vol.2010 , Issue.340 , pp. c869
    • Moher, D.1    Hopewell, S.2    Schulz, K.F.3    Montori, V.4    Gotzsche, P.C.5    Devereaux, P.J.6
  • 41
    • 84920621681 scopus 로고    scopus 로고
    • Clinical trials registration and results submission
    • Nov 21 articles/2014/11/21/2014-26197/clinical-trials-registration-and-results-submission
    • Department of Health and Human Services (US). Clinical trials registration and results submission. Proposed rule. Fed Regist. 2014 Nov 21; 79(225):69566-680. Available: https://www.federalregister.gov/ articles/2014/11/21/2014-26197/clinical-trials-registration-and-results-submission.
    • (2014) Proposed Rule. Fed Regist , vol.79 , Issue.225 , pp. 69566-69680
    • Department of Health and Human Services (US)1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.