A Decade On: Systematic Review of ClinicalTrials.gov Infectious Disease Trials, 2007-2017.
Abstract
Background:Registration of interventional trials of Food and Drug Administration-regulated
drug and biological products and devices became a legal requirement in 2007; the vast
majority of these trials are registered in ClinicalTrials.gov. An analysis of ClinicalTrials.gov
offers an opportunity to define the clinical research landscape; here we analyze 10
years of infectious disease (ID) clinical trial research. Methods:Beginning with 166
415 interventional trials registered in ClinicalTrials.gov from 2007-2017, ID trials
were selected by study conditions and interventions. Relevance to ID was confirmed
through manual review, resulting in 13 707 ID trials and 152 708 non-ID trials. Results:ID-related
trials represented 6.9%-9.9% of all trials with no significant trend over time. ID
trials tended to be more focused on treatment and prevention, with a focus on testing
drugs, biologics, and vaccines. ID trials tended to be large, randomized, and nonblinded
with a greater degree of international enrollment. Industry was the primary funding
source for 45.2% of ID trials. Compared with the global burden of disease, human immunodeficiency
virus/AIDS and hepatitis C trials were overrepresented, and lower respiratory tract
infection trials were underrepresented. Hepatitis C trials fluctuated, keeping with
a wave of new drug development. Influenza vaccine trials peaked during the 2009 H1N1
swine influenza outbreak. Conclusions:This study presents the most comprehensive characterization
of ID clinical trials over the past decade. These results help define how clinical
research aligns with clinical need. Temporal trends reflect changes in disease epidemiology
and the impact of scientific discovery and market forces. Periodic review of ID clinical
trials can help identify gaps and serve as a mechanism to realign resources.
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https://hdl.handle.net/10161/19462Published Version (Please cite this version)
10.1093/ofid/ofz189Publication Info
Jaffe, Ian S; Chiswell, Karen; & Tsalik, Ephraim L (2019). A Decade On: Systematic Review of ClinicalTrials.gov Infectious Disease Trials, 2007-2017.
Open forum infectious diseases, 6(6). pp. ofz189. 10.1093/ofid/ofz189. Retrieved from https://hdl.handle.net/10161/19462.This is constructed from limited available data and may be imprecise. To cite this
article, please review & use the official citation provided by the journal.
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Show full item recordScholars@Duke
Karen Chiswell
Statistical Scientist
Ph.D., North Carolina State University - 2007I work closely with clinical and quantitative
colleagues to provide statistical leadership, guidance and mentoring on the design, execution,
and analysis of clinical research studies. My work includes design and analysis of
observational studies (including large cardiovascular registries, and clinical care
databases linke
Ephraim Tsalik
Adjunct Associate Professor in the Department of Medicine
My research at Duke has focused on understanding the dynamic between host and pathogen
so as to discover and develop host-response markers that can diagnose and predict
health and disease. This new and evolving approach to diagnosing illness has the
potential to significantly impact individual as well as public health considering
the rise of antibiotic resistance.
With any potential infectious disease diagnosis, it is difficult, if not impossible,
to determine at the time of pre
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