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A Decade On: Systematic Review of ClinicalTrials.gov Infectious Disease Trials, 2007-2017.

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Date
2019-06
Authors
Jaffe, Ian S
Chiswell, Karen
Tsalik, Ephraim L
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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.
Type
Journal article
Subject
clinical trials
hepatitis C
infectious disease
policy
Permalink
https://hdl.handle.net/10161/19462
Published Version (Please cite this version)
10.1093/ofid/ofz189
Publication 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.
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Scholars@Duke

Chiswell

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
Tsalik

Ephraim Tsalik

Adjunct Associate Professor in the Department of Medicine
My research is 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 presentation
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