Dataset Information

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 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consistent reporting of results in ClinicalTrials.gov would help make ClinicalTrials.gov records more useful in finding unpublished information and identifying potential biases.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.

SUBMITTER: Adam GP

PROVIDER: S-EPMC5902969 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Does information from ClinicalTrials.gov increase transparency and reduce bias? Results from a five-report case series.

Adam Gaelen P GP Springs Stacey S Trikalinos Thomas T Williams John W JW Eaton Jennifer L JL Von Isenburg Megan M Gierisch Jennifer M JM Wilson Lisa M LM Robinson Karen A KA Viswanathan Meera M Middleton Jennifer Cook JC Forman-Hoffman Valerie L VL Berliner Elise E Kaplan Robert M RM

Systematic reviews 20180416 1

<h4>Background</h4>We investigated whether information in ClinicalTrials.gov would impact the conclusions of five ongoing systematic reviews.<h4>Method</h4>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 th ...[more]

PMID: 29661214

Similar Datasets

Project description:The Food and Drug Administration Amendments Act (FDAAA) mandates timely reporting of results of applicable clinical trials to ClinicalTrials.gov. We characterized the proportion of applicable clinical trials with publicly available results and determined independent factors associated with the reporting of results.Using an algorithm based on input from the National Library of Medicine, we identified trials that were likely to be subject to FDAAA provisions (highly likely applicable clinical trials, or HLACTs) from 2008 through 2013. We determined the proportion of HLACTs that reported results within the 12-month interval mandated by the FDAAA or at any time during the 5-year study period. We used regression models to examine characteristics associated with reporting at 12 months and throughout the 5-year study period.From all the trials at ClinicalTrials.gov, we identified 13,327 HLACTs that were terminated or completed from January 1, 2008, through August 31, 2012. Of these trials, 77.4% were classified as drug trials. A total of 36.9% of the trials were phase 2 studies, and 23.4% were phase 3 studies; 65.6% were funded by industry. Only 13.4% of trials reported summary results within 12 months after trial completion, whereas 38.3% reported results at any time up to September 27, 2013. Timely reporting was independently associated with factors such as FDA oversight, a later trial phase, and industry funding. A sample review suggested that 45% of industry-funded trials were not required to report results, as compared with 6% of trials funded by the National Institutes of Health (NIH) and 9% of trials that were funded by other government or academic institutions.Despite ethical and legal obligations to disclose findings promptly, most HLACTs did not report results to ClinicalTrials.gov in a timely fashion during the study period. Industry-funded trials adhered to legal obligations more often than did trials funded by the NIH or other government or academic institutions. (Funded by the Clinical Trials Transformation Initiative and the NIH.).

Dataset Information

Does information from ClinicalTrials.gov increase transparency and reduce bias? Results from a five-report case series.

Publications

Does information from ClinicalTrials.gov increase transparency and reduce bias? Results from a five-report case series.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets