Reporting Discrepancies between the ClinicalTrials.gov Results Database and Peer Reviewed Publications Public Deposited

http://ir.library.oregonstate.edu/concern/articles/t435gf91n

This is an author's peer-reviewed final manuscript, as accepted by the publisher. The published article is copyrighted by the American College of Physicians and can be found at:  http://annals.org/.

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  • BACKGROUND: Result summaries are now required to be reported in ClinicalTrials.gov for many 1 trials of drugs and devices. PURPOSE: To evaluate the consistency of reporting in trials that are both registered in the ClinicalTrials.gov results database and published in the literature. DATA SOURCES: ClinicalTrials.gov results database, matched publications identified through both ClinicalTrials.gov and a manual search of two electronic databases. STUDY SELECTION: 10% random sample of Phase III or IV trials with results in the ClinicalTrials.gov results database, completed before January 1, 2009, with two or more arms. DATA EXTRACTION: One reviewer extracted data from ClinicalTrials.gov results database and matching publications. A subsample was independently verified. Basic design features and results were compared between reporting sources and discrepancies were summarized. DATA SYNTHESIS: Of 110 reviewed trials with results, most were industry-sponsored, parallel design, drug studies. The most common inconsistency was the number of secondary outcome measures reported (80%). There were 16 trials (15%) that reported the primary outcome description inconsistently and 22 (20%) in which the primary outcome value was reported inconsistently. A total of 38 trials inconsistently reported the number of individuals with a serious adverse event (SAE), of which 33 (87%) reported more SAEs in ClinicalTrials.gov. Among the 84 trials that reported SAEs in ClinicalTrials.gov, 11 publications did not mention SAEs, 5 reported SAEs as zero or not occurring, and 21 reported a different number of SAEs. In 29 trials that reported deaths in ClinicalTrials.gov, 28% differed with the matched publication. LIMITATIONS: Small sample that includes earliest results posted to the database and therefore may reflect inexperience with the submission process. CONCLUSIONS: Reporting discrepancies between the ClinicalTrials.gov results database and matching publications are common. It is unclear which reporting source contains the most accurate account of trial results. ClinicalTrials.gov may provide a more comprehensive description of trial adverse events than the publication.
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  • Hartung, D. M., Zarin, D. A., Guise, J. M., McDonagh, M., Paynter, R., & Helfand, M. (2014). Reporting Discrepancies Between the ClinicalTrials.gov Results Database and Peer-Reviewed Publications. Annals of Internal Medicine, 160(7), 477-483.
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  • description.provenance : Made available in DSpace on 2014-07-02T20:08:04Z (GMT). No. of bitstreams: 4 HartungDanielPharmacyReportingDiscrepanciesBetween.pdf: 511357 bytes, checksum: 027cc9329af93e057b977e44941cb1c2 (MD5) HartungDanielPharmacyReportingDiscrepanciesBetween_TableS1.pdf: 177034 bytes, checksum: aa1ee1445c0f084af3a956373132d194 (MD5) HartungDanielPharmacyReportingDiscrepanciesBetween_TableS2.pdf: 389515 bytes, checksum: df8c0118e850323f1bbff9a173966d3c (MD5) HartungDanielPharmacyReportingDiscrepanciesBetween_TableS3.pdf: 212814 bytes, checksum: 860b7247dd87affeb9ad2025476d0917 (MD5) Previous issue date: 2014-04-01
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  • description.provenance : Submitted by Erin Clark (erin.clark@oregonstate.edu) on 2014-07-02T20:07:32Z No. of bitstreams: 4 HartungDanielPharmacyReportingDiscrepanciesBetween.pdf: 511357 bytes, checksum: 027cc9329af93e057b977e44941cb1c2 (MD5) HartungDanielPharmacyReportingDiscrepanciesBetween_TableS1.pdf: 177034 bytes, checksum: aa1ee1445c0f084af3a956373132d194 (MD5) HartungDanielPharmacyReportingDiscrepanciesBetween_TableS2.pdf: 389515 bytes, checksum: df8c0118e850323f1bbff9a173966d3c (MD5) HartungDanielPharmacyReportingDiscrepanciesBetween_TableS3.pdf: 212814 bytes, checksum: 860b7247dd87affeb9ad2025476d0917 (MD5)

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