GSBS Dissertations and Theses

ORCID ID

0000-0002-3369-8308

Approval Date

11-30-2017

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 Guidelines for systematic reviews recommend authors to routinely search of trial registries to identify unpublished studies.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.

DOI

10.13028/M27H6R

Rights and Permissions

Copyright is held by the author, with all rights reserved.

Available for download on Saturday, December 29, 2018

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