Does information from ClinicalTrials.gov increase transparency and reduce bias? Results from a five-report case series
Abstract Background We investigated whether information in ClinicalTrials.gov would impact the conclusions of five ongoing systematic reviews. Method We considered five reviews that included 495 studies total. Each review team conducted a search of ClinicalTrials.gov up to the date of the review’s l...
| Main Authors: | , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
BMC
2018-04-01
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| Series: | Systematic Reviews |
| Online Access: | http://link.springer.com/article/10.1186/s13643-018-0726-5 |
| _version_ | 1819139121156718592 |
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| author | Gaelen P. Adam Stacey Springs Thomas Trikalinos John W. Williams Jennifer L. Eaton Megan Von Isenburg Jennifer M. Gierisch Lisa M. Wilson Karen A. Robinson Meera Viswanathan Jennifer Cook Middleton Valerie L. Forman-Hoffman Elise Berliner Robert M. Kaplan |
| author_facet | Gaelen P. Adam Stacey Springs Thomas Trikalinos John W. Williams Jennifer L. Eaton Megan Von Isenburg Jennifer M. Gierisch Lisa M. Wilson Karen A. Robinson Meera Viswanathan Jennifer Cook Middleton Valerie L. Forman-Hoffman Elise Berliner Robert M. Kaplan |
| author_sort | Gaelen P. Adam |
| collection | DOAJ |
| description | Abstract Background We investigated whether information in ClinicalTrials.gov would impact the conclusions of five ongoing systematic reviews. Method We considered five reviews that included 495 studies total. Each review team conducted a search of ClinicalTrials.gov up to the date of the review’s last literature search, screened the records using the review’s eligibility criteria, extracted information, and assessed risk of bias and applicability. Each team then evaluated the impact of the evidence found in ClinicalTrials.gov on the conclusions in the review. Results Across the five reviews, the number of studies that had both a registry record and a publication varied widely, from none in one review to 43% of all studies identified in another. Among the studies with both a record and publication, there was also wide variability in the match between published outcomes and those listed in ClinicalTrials.gov. Of the 173 total ClinicalTrials.gov records identified across the five projects, between 11 and 43% did not have an associated publication. In the 14% of records that contained results, the new data provided in the ClinicalTrials.gov records did not change the results or conclusions of the reviews. Finally, a large number of published studies were not registered in ClinicalTrials.gov, but many of these were published before ClinicalTrials.gov’s inception date of 2000. Conclusion Improved prospective registration of trials and consistent reporting of results in ClinicalTrials.gov would help make ClinicalTrials.gov records more useful in finding unpublished information and identifying potential biases. In addition, consistent indexing in databases, such as MEDLINE, would allow for better matching of records and publications, leading to increased utility of these searches for systematic review projects. |
| first_indexed | 2024-12-22T11:17:37Z |
| format | Article |
| id | doaj.art-3ec0858f45a949ec8d9893d155d4bc10 |
| institution | Directory Open Access Journal |
| issn | 2046-4053 |
| language | English |
| last_indexed | 2024-12-22T11:17:37Z |
| publishDate | 2018-04-01 |
| publisher | BMC |
| record_format | Article |
| series | Systematic Reviews |
| spelling | doaj.art-3ec0858f45a949ec8d9893d155d4bc102022-12-21T18:27:58ZengBMCSystematic Reviews2046-40532018-04-01711810.1186/s13643-018-0726-5Does information from ClinicalTrials.gov increase transparency and reduce bias? Results from a five-report case seriesGaelen P. Adam0Stacey Springs1Thomas Trikalinos2John W. Williams3Jennifer L. Eaton4Megan Von Isenburg5Jennifer M. Gierisch6Lisa M. Wilson7Karen A. Robinson8Meera Viswanathan9Jennifer Cook Middleton10Valerie L. Forman-Hoffman11Elise Berliner12Robert M. Kaplan13Brown University Evidence-based Practice CenterBrown University Evidence-based Practice CenterBrown University Evidence-based Practice CenterDuke University Evidence-based Practice CenterDuke University Evidence-based Practice CenterDuke University Evidence-based Practice CenterDuke University Evidence-based Practice CenterJohns Hopkins University Evidence-based Practice CenterJohns Hopkins University Evidence-based Practice CenterRTI/UNC Evidence-based Practice CenterRTI/UNC Evidence-based Practice CenterRTI/UNC Evidence-based Practice CenterAgency for Healthcare Research and QualityStanford University Clinical Excellence Research CenterAbstract Background We investigated whether information in ClinicalTrials.gov would impact the conclusions of five ongoing systematic reviews. Method We considered five reviews that included 495 studies total. Each review team conducted a search of ClinicalTrials.gov up to the date of the review’s last literature search, screened the records using the review’s eligibility criteria, extracted information, and assessed risk of bias and applicability. Each team then evaluated the impact of the evidence found in ClinicalTrials.gov on the conclusions in the review. Results Across the five reviews, the number of studies that had both a registry record and a publication varied widely, from none in one review to 43% of all studies identified in another. Among the studies with both a record and publication, there was also wide variability in the match between published outcomes and those listed in ClinicalTrials.gov. Of the 173 total ClinicalTrials.gov records identified across the five projects, between 11 and 43% did not have an associated publication. In the 14% of records that contained results, the new data provided in the ClinicalTrials.gov records did not change the results or conclusions of the reviews. Finally, a large number of published studies were not registered in ClinicalTrials.gov, but many of these were published before ClinicalTrials.gov’s inception date of 2000. Conclusion Improved prospective registration of trials and consistent reporting of results in ClinicalTrials.gov would help make ClinicalTrials.gov records more useful in finding unpublished information and identifying potential biases. In addition, consistent indexing in databases, such as MEDLINE, would allow for better matching of records and publications, leading to increased utility of these searches for systematic review projects.http://link.springer.com/article/10.1186/s13643-018-0726-5 |
| spellingShingle | Gaelen P. Adam Stacey Springs Thomas Trikalinos John W. Williams Jennifer L. Eaton Megan Von Isenburg Jennifer M. Gierisch Lisa M. Wilson Karen A. Robinson Meera Viswanathan Jennifer Cook Middleton Valerie L. Forman-Hoffman Elise Berliner Robert M. Kaplan Does information from ClinicalTrials.gov increase transparency and reduce bias? Results from a five-report case series Systematic Reviews |
| title | Does information from ClinicalTrials.gov increase transparency and reduce bias? Results from a five-report case series |
| title_full | Does information from ClinicalTrials.gov increase transparency and reduce bias? Results from a five-report case series |
| title_fullStr | Does information from ClinicalTrials.gov increase transparency and reduce bias? Results from a five-report case series |
| title_full_unstemmed | Does information from ClinicalTrials.gov increase transparency and reduce bias? Results from a five-report case series |
| title_short | Does information from ClinicalTrials.gov increase transparency and reduce bias? Results from a five-report case series |
| title_sort | does information from clinicaltrials gov increase transparency and reduce bias results from a five report case series |
| url | http://link.springer.com/article/10.1186/s13643-018-0726-5 |
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