Reporting discrepancies between the ClinicalTrials.gov results database and peer-reviewed publications
BACKGROUND: ClinicalTrials.gov requires reporting of result summaries for many drug and device trials.
PURPOSE: To evaluate the consistency of reporting of trials that are registered in the ClinicalTrials.gov results database and published in the literature.
DATA SOURCES: ClinicalTrials.gov results database and matched publications identified through ClinicalTrials.gov and a manual search of 2 electronic databases.
STUDY SELECTION: 10% random sample of phase 3 or 4 trials with results in the ClinicalTrials.gov results database, completed before 1 January 2009, with 2 or more groups.
DATA EXTRACTION: One reviewer extracted data about trial design and results from the results database and matching publications. A subsample was independently verified.
DATA SYNTHESIS: Of 110 trials with results, most were industry-sponsored, parallel-design drug studies. The most common inconsistency was the number of secondary outcome measures reported (80%). Sixteen trials (15%) reported the primary outcome description inconsistently, and 22 (20%) reported the primary outcome value inconsistently. Thirty-eight trials inconsistently reported the number of individuals with a serious adverse event (SAE); of these, 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 them as zero or not occurring, and 21 reported a different number of SAEs. Among 29 trials that reported deaths in ClinicalTrials.gov, 28% differed from the matched publication.
LIMITATION: Small sample that included earliest results posted to the database.
CONCLUSION: Reporting discrepancies between the ClinicalTrials.gov results database and matching publications are common. Which source contains the more accurate account of results is unclear, although ClinicalTrials.gov may provide a more comprehensive description of adverse events than the publication.
PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality.
| Errataetall: | |
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| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2014 |
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| Erschienen: |
2014 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:160 |
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| Enthalten in: |
Annals of internal medicine - 160(2014), 7 vom: 01. Apr., Seite 477-83 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Hartung, Daniel M [VerfasserIn] |
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| Links: |
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| Themen: |
Journal Article |
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| Anmerkungen: |
Date Completed 09.06.2014 Date Revised 17.03.2022 published: Print CommentIn: BMJ. 2014;348:g2503. - PMID 24691001 Citation Status MEDLINE |
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| doi: |
10.7326/M13-0480 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM236932640 |
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| 500 | |a Date Revised 17.03.2022 | ||
| 500 | |a published: Print | ||
| 500 | |a CommentIn: BMJ. 2014;348:g2503. - PMID 24691001 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a BACKGROUND: ClinicalTrials.gov requires reporting of result summaries for many drug and device trials | ||
| 520 | |a PURPOSE: To evaluate the consistency of reporting of trials that are registered in the ClinicalTrials.gov results database and published in the literature | ||
| 520 | |a DATA SOURCES: ClinicalTrials.gov results database and matched publications identified through ClinicalTrials.gov and a manual search of 2 electronic databases | ||
| 520 | |a STUDY SELECTION: 10% random sample of phase 3 or 4 trials with results in the ClinicalTrials.gov results database, completed before 1 January 2009, with 2 or more groups | ||
| 520 | |a DATA EXTRACTION: One reviewer extracted data about trial design and results from the results database and matching publications. A subsample was independently verified | ||
| 520 | |a DATA SYNTHESIS: Of 110 trials with results, most were industry-sponsored, parallel-design drug studies. The most common inconsistency was the number of secondary outcome measures reported (80%). Sixteen trials (15%) reported the primary outcome description inconsistently, and 22 (20%) reported the primary outcome value inconsistently. Thirty-eight trials inconsistently reported the number of individuals with a serious adverse event (SAE); of these, 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 them as zero or not occurring, and 21 reported a different number of SAEs. Among 29 trials that reported deaths in ClinicalTrials.gov, 28% differed from the matched publication | ||
| 520 | |a LIMITATION: Small sample that included earliest results posted to the database | ||
| 520 | |a CONCLUSION: Reporting discrepancies between the ClinicalTrials.gov results database and matching publications are common. Which source contains the more accurate account of results is unclear, although ClinicalTrials.gov may provide a more comprehensive description of adverse events than the publication | ||
| 520 | |a PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, N.I.H., Extramural | |
| 650 | 4 | |a Research Support, N.I.H., Intramural | |
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| 700 | 1 | |a Guise, Jeanne-Marie |e verfasserin |4 aut | |
| 700 | 1 | |a McDonagh, Marian |e verfasserin |4 aut | |
| 700 | 1 | |a Paynter, Robin |e verfasserin |4 aut | |
| 700 | 1 | |a Helfand, Mark |e verfasserin |4 aut | |
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