메뉴 건너뛰기




Volumn 362, Issue , 2018, Pages

Compliance with requirement to report results on the EU Clinical Trials Register: Cohort study and web resource

Author keywords

[No Author keywords available]

Indexed keywords

ADULT; ARTICLE; CLINICAL TRIAL (TOPIC); COHORT ANALYSIS; ERROR; FEMALE; HUMAN; MALE; OUTCOME ASSESSMENT; PUBLICATION; RETROSPECTIVE STUDY; SYSTEMATIC REVIEW; EUROPEAN UNION; FACTUAL DATABASE; MANAGEMENT; PROTOCOL COMPLIANCE; REGISTER; STATISTICS AND NUMERICAL DATA;

EID: 85053340161     PISSN: 09598146     EISSN: 17561833     Source Type: Journal    
DOI: 10.1136/bmj.k3218     Document Type: Article
Times cited : (130)

References (25)
  • 1
    • 0025099275 scopus 로고
    • Underreporting research is scientific misconduct
    • Chalmers I. Underreporting research is scientific misconduct. JAMA 1990;263:1405-8. doi:10.1001/jama.1990.03440100121018
    • (1990) JAMA , vol.263 , pp. 1405-1408
    • Chalmers, I.1
  • 2
    • 0023008125 scopus 로고
    • Publication bias: The case for an international registry of clinical trials
    • Simes RJ. Publication bias: The case for an international registry of clinical trials. J Clin Oncol 1986;4:1529-41. doi:10.1200/JCO.1986.4.10.1529
    • (1986) J Clin Oncol , vol.4 , pp. 1529-1541
    • Simes, R.J.1
  • 3
    • 84888610885 scopus 로고    scopus 로고
    • World Medical Association Declaration of Helsinki: Ethical principles for medical research involving human subjects
    • World Medical Association
    • World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA 2013;310:2191-4. doi:10.1001/jama.2013.281053
    • (2013) JAMA , vol.310 , pp. 2191-2194
  • 4
    • 84930536158 scopus 로고    scopus 로고
    • Rationale for WHO's new position calling for prompt reporting and public disclosure of interventional clinical trial results
    • Moorthy VS, Karam G, Vannice KS, et al. Rationale for WHO's new position calling for prompt reporting and public disclosure of interventional clinical trial results. PLoS Med 2015;12:e1001819. doi:10.1371/journal.pmed.1001819
    • (2015) PLoS Med , vol.12 , pp. e1001819
    • Moorthy, V.S.1    Karam, G.2    Vannice, K.S.3
  • 6
    • 85053344945 scopus 로고    scopus 로고
    • Food and Drug Administration Amendments Act of 2007. 2007
    • Food and Drug Administration Amendments Act of 2007. 2007. https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/SignificantAmendmentstotheFDCAct/FoodandDrugAdministrationAmendmentsActof2007/FullTextofFDAAALaw/default.htm
  • 7
    • 84919808207 scopus 로고    scopus 로고
    • Extent of non-publication in cohorts of studies approved by research ethics committees or included in trial registries
    • Schmucker C, Schell LK, Portalupi S, et al. Extent of non-publication in cohorts of studies approved by research ethics committees or included in trial registries. PLoS One 2014;9:e114023. doi:10.1371/journal.pone.0114023
    • (2014) PLoS One , vol.9 , pp. e114023
    • Schmucker, C.1    Schell, L.K.2    Portalupi, S.3
  • 8
    • 72849132173 scopus 로고    scopus 로고
    • Dissemination and publication of research findings: An updated review of related biases
    • 1-193
    • Song F, Parekh S, Hooper L, et al. Dissemination and publication of research findings: An updated review of related biases. Health Technol Assess 2010;14:ix-xi, 1-193. doi:10.3310/hta14080
    • (2010) Health Technol Assess , vol.14 , pp. ix-xi
    • Song, F.1    Parekh, S.2    Hooper, L.3
  • 9
    • 84859005251 scopus 로고    scopus 로고
    • Compliance with mandatory reporting of clinical trial results on ClinicalTrials. gov: Cross sectional study
    • Prayle AP, Hurley MN, Smyth AR. Compliance with mandatory reporting of clinical trial results on ClinicalTrials. gov: cross sectional study. BMJ 2012;344:d7373. doi:10.1136/bmj.d7373
    • (2012) BMJ , vol.344 , pp. d7373
    • Prayle, A.P.1    Hurley, M.N.2    Smyth, A.R.3
  • 10
    • 84924691950 scopus 로고    scopus 로고
    • Compliance with results reporting at ClinicalTrials. gov
    • Anderson ML, Chiswell K, Peterson ED, et al. Compliance with results reporting at ClinicalTrials.gov. N Engl J Med 2015;372:1031-9. doi:10.1056/NEJMsa1409364.
    • (2015) N Engl J Med , vol.372 , pp. 1031-1039
    • Anderson, M.L.1    Chiswell, K.2    Peterson, E.D.3
  • 11
    • 85053340547 scopus 로고    scopus 로고
    • Dept. of Health and Human Services
    • Dept. of Health and Human Services. Final Rule-Clinical Trials Registration and Results Information Submission. 2016;81:64982-5157.https://www.federalregister.gov/documents/2016/09/21/2016-22129/clinical-trials-registrationand-results-information-submission
    • (2016) Final Rule-Clinical Trials Registration and Results Information Submission , vol.81 , pp. 64982-65157
  • 12
    • 84896737610 scopus 로고    scopus 로고
    • Commission Guideline-Guidance on Posting and Publication of Result-Related Information on Clinical Trials in Relation to the Implementation of Article 57(2) of Regulation (EC) No 726/2004 and Article 41(2) of Regulation (EC) No 1901/2006
    • Commission Guideline-Guidance on Posting and Publication of Result-Related Information on Clinical Trials in Relation to the Implementation of Article 57(2) of Regulation (EC) No 726/2004 and Article 41(2) of Regulation (EC) No 1901/2006. Official J Eur Union 2012;55:7-10.
    • (2012) Official J Eur Union , vol.55 , pp. 7-10
  • 13
    • 85053299018 scopus 로고    scopus 로고
    • European Commission. Technical Guidance on the Format of the Data Fields of Result-Related Information on Clinical Trials Submitted in Accordance with Article 57(2) of Regulation (EC) No 726/2004 and Article 41(2) of Regulation
    • European Commission. Technical Guidance on the Format of the Data Fields of Result-Related Information on Clinical Trials Submitted in Accordance with Article 57(2) of Regulation (EC) No 726/2004 and Article 41(2) of Regulation. 2013. https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/2013-01-22-tg-en.pdf
    • (2013)
  • 14
    • 85053307612 scopus 로고    scopus 로고
    • European Medicines Agency. EudraCT Home Page. 2016(accessed 6 Apr 2017)
    • European Medicines Agency. EudraCT Home Page. 2016. https://eudract.ema.europa.eu/whatsnew.html (accessed 6 Apr 2017).
  • 15
    • 85053291628 scopus 로고    scopus 로고
    • European Medicines Agency. European Medicines Agency. Trial Results: Modalities and timing of Posting. 2016
    • European Medicines Agency. European Medicines Agency. Trial Results: Modalities and timing of Posting. 2016. https://eudract.ema. europa.eu/docs/guidance/Trial%20results-Modalities%20and%20 timing%20of%20posting.docx
  • 16
    • 84962788942 scopus 로고    scopus 로고
    • OpenTrials: Towards a collaborative open database of all available information on all clinical trials
    • Goldacre B, Gray J. OpenTrials: Towards a collaborative open database of all available information on all clinical trials. Trials 2016;17:164. doi:10.1186/s13063-016-1290-8
    • (2016) Trials , vol.17 , pp. 164
    • Goldacre, B.1    Gray, J.2
  • 17
    • 85053343238 scopus 로고    scopus 로고
    • https://github.com/ebmdatalab/euctr-tracker-code
  • 18
    • 85053348310 scopus 로고    scopus 로고
    • https://github.com/ebmdatalab/euctr-tracker-data
  • 19
    • 84872084158 scopus 로고    scopus 로고
    • Does use of the CONSORT Statement impact the completeness of reporting of randomised controlled trials published in medical journals A Cochrane review
    • Turner L, Shamseer L, Altman DG, et al. Does use of the CONSORT Statement impact the completeness of reporting of randomised controlled trials published in medical journals A Cochrane review. Syst Rev 2012;1:60. doi:10.1186/2046-4053-1-60.
    • (2012) Syst Rev , vol.1 , pp. 60
    • Turner, L.1    Shamseer, L.2    Altman, D.G.3
  • 20
    • 84897417340 scopus 로고    scopus 로고
    • Reporting discrepancies between the ClinicalTrials. gov results database and peer-reviewed publications
    • Hartung DM, Zarin DA, Guise J-M, et al. Reporting discrepancies between the ClinicalTrials.gov results database and peer-reviewed publications. Ann Intern Med 2014;160:477-83. doi:10.7326/M13-0480
    • (2014) Ann Intern Med , vol.160 , pp. 477-483
    • Hartung, D.M.1    Zarin, D.A.2    Guise, J.-M.3
  • 21
    • 84892584964 scopus 로고    scopus 로고
    • Timing and Completeness of Trial Results Posted at ClinicalTrials. gov and Published in Journals
    • 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:e1001566. doi:10.1371/journal.pmed.1001566.
    • (2013) PLoS Med , vol.10 , pp. e1001566
    • Riveros, C.1    Dechartres, A.2    Perrodeau, E.3    Haneef, R.4    Boutron, I.5    Ravaud, P.6
  • 22
    • 84919876447 scopus 로고    scopus 로고
    • Rate of asthma trial outcomes reporting on ClinicalTrials. gov and in the published literature
    • Stockmann C, Ross JS, Sherwin CMT, et al. Rate of asthma trial outcomes reporting on ClinicalTrials.gov and in the published literature. J Allergy Clin Immunol 2014;134:1443-6 doi:10.1016/j.jaci.2014.09.019
    • (2014) J Allergy Clin Immunol , vol.134 , pp. 1443-1446
    • Stockmann, C.1    Ross, J.S.2    Sherwin, C.M.T.3
  • 23
    • 84946827399 scopus 로고    scopus 로고
    • Clinical trial registration, reporting, publication and FDAAA compliance: A cross-sectional analysis and ranking of new drugs approved by the FDA in 2012
    • Miller JE, Korn D, Ross JS. Clinical trial registration, reporting, publication and FDAAA compliance: A cross-sectional analysis and ranking of new drugs approved by the FDA in 2012. BMJ Open 2015;5:e009758. doi:10.1136/bmjopen-2015-009758
    • (2015) BMJ Open , vol.5 , pp. e009758
    • Miller, J.E.1    Korn, D.2    Ross, J.S.3
  • 24
    • 84960083687 scopus 로고    scopus 로고
    • Publication and reporting of clinical trial results: Cross sectional analysis across academic medical centers
    • Chen R, Desai NR, Ross JS, et al. Publication and reporting of clinical trial results: cross sectional analysis across academic medical centers. BMJ 2016;352:i637 doi:10.1136/bmj.i637
    • (2016) BMJ , vol.352 , pp. i637
    • Chen, R.1    Desai, N.R.2    Ross, J.S.3
  • 25
    • 44849102427 scopus 로고    scopus 로고
    • Audit: How to do it in practice
    • Benjamin A. Audit: how to do it in practice. BMJ 2008;336:1241-5 doi:10.1136/bmj.39527.628322.AD
    • (2008) BMJ , vol.336 , pp. 1241-1245
    • Benjamin, A.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.