Prevalence of clinical trial status discrepancies: A cross-sectional study of 10,492 trials registered on both ClinicalTrials.gov and the European Union Clinical Trials Register

Jessica Fleminger; Ben Goldacre

doi:10.1371/journal.pone.0193088

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Open Access

Peer-reviewed

Research Article

Prevalence of clinical trial status discrepancies: A cross-sectional study of 10,492 trials registered on both ClinicalTrials.gov and the European Union Clinical Trials Register

Jessica Fleminger,

Roles Data curation, Formal analysis, Investigation, Writing – original draft

Affiliation Centre for Evidence Based Medicine, Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom

http://orcid.org/0000-0002-5744-5137

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Ben Goldacre

Roles Conceptualization, Funding acquisition, Supervision, Writing – review & editing

* E-mail: ben.goldacre@phc.ox.ac.uk

Affiliation Centre for Evidence Based Medicine, Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom

http://orcid.org/0000-0002-5127-4728

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Prevalence of clinical trial status discrepancies: A cross-sectional study of 10,492 trials registered on both ClinicalTrials.gov and the European Union Clinical Trials Register

Jessica Fleminger,
Ben Goldacre

Published: March 7, 2018
https://doi.org/10.1371/journal.pone.0193088

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Role of inspections

Posted by bedwards138 on 08 Mar 2018 at 18:18 GMT

It is worth noting that as far as I am aware recording of clinical trials is not part of a routine GCP inspection for either US FDA or any EU authority. Certainly quality checks by inspectors do not occur. Not aware that they are part of a sponsor GCP audit program routinely . Maybe the authors would care to raise this with the relevant authorities to see whether that might help improve the quality of registration?

No competing interests declared.

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Prevalence of clinical trial status discrepancies: A cross-sectional study of 10,492 trials registered on both ClinicalTrials.gov and the European Union Clinical Trials Register

Prevalence of clinical trial status discrepancies: A cross-sectional study of 10,492 trials registered on both ClinicalTrials.gov and the European Union Clinical Trials Register

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Role of inspections

Posted by bedwards138 on 08 Mar 2018 at 18:18 GMT