Use of ClinicalTrials.gov Registry in Systematic Reviews and Meta-analyses: A Master's Thesis
Authors
Pradhan, RicheekFaculty Advisor
Hong Yu; Robert GoldbergAcademic Program
Interdisciplinary Graduate ProgramUMass Chan Affiliations
Quantitative Health SciencesDocument Type
Master's ThesisPublication Date
2017-11-30Keywords
ClinicalTrials.gov; Systematic Reviews; Meta-analyses; Information sources; Safety dataHealth Information Technology
Medicine and Health Sciences
Pharmacy and Pharmaceutical Sciences
Public Health
Metadata
Show full item recordAbstract
Ensuring the objectivity of systematic reviews and meta-analyses (SRMA) begins with comprehensive searches into diverse resources mining primary studies. Guidelines for systematic reviews recommend authors to routinely search of trial registries to identify unpublished studies. In this dissertation, I investigated the utilization of ClinicalTrials.gov (CTG), the world’s largest clinical trial registry that contains data from clinical trials of products that are subject to United States Food and Drug Administration (FDA) regulation, as an information resource in SRMAs. First, I examined the use of various information resources including CTG in SRMAs published from 2005-2016, and identified the factors associated with their use. Thereafter, to determine the accuracy of trial safety data reported at CTG, I compared the data at CTG with that in corresponding journal articles and FDA drug reviews. I found that trial safety data at both CTG and articles differed frequently from FDA drug reviews, but the differences were modest in magnitude. Finally, I repeated published meta-analysis (conducted using data from primary study articles) with data at CTG to find that most meta-analysis results were reproduced using CTG data. Taken together, this work suggests that CTG should not only be searched more often to find primary research for systematic reviews, but that data at CTG can also be used to conduct quantitative data synthesis.DOI
10.13028/M27H6RPermanent Link to this Item
http://hdl.handle.net/20.500.14038/32320Rights
Copyright is held by the author, with all rights reserved.ae974a485f413a2113503eed53cd6c53
10.13028/M27H6R