ORCID ID
0000-0002-3369-8308
Publication Date
2017-11-30
Document Type
Master's Thesis
Academic Program
Interdisciplinary Graduate Program
Department
Quantitative Health Sciences
First Thesis Advisor
Hong Yu
Second Thesis Advisor
Robert Goldberg
Keywords
ClinicalTrials.gov; Systematic Reviews; Meta-analyses; Information sources; Safety data
Abstract
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 Guidelines for systematic reviews recommend authors to routinely search of trial registries to identify unpublished studies.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.
Repository Citation
Pradhan R. (2017). Use of ClinicalTrials.gov Registry in Systematic Reviews and Meta-analyses: A Master's Thesis. Morningside Graduate School of Biomedical Sciences Dissertations and Theses. https://doi.org/10.13028/M27H6R. Retrieved from https://escholarship.umassmed.edu/gsbs_diss/937
DOI
10.13028/M27H6R
DOI Link
Rights and Permissions
Copyright is held by the author, with all rights reserved.
Included in
Health Information Technology Commons, Pharmacy and Pharmaceutical Sciences Commons, Public Health Commons