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

dc.contributor.author Jaffe, Ian S
dc.contributor.author Chiswell, Karen
dc.contributor.author Tsalik, Ephraim L
dc.date.accessioned 2019-11-01T15:05:30Z
dc.date.available 2019-11-01T15:05:30Z
dc.date.issued 2019-06
dc.identifier ofz189
dc.identifier.issn 2328-8957
dc.identifier.issn 2328-8957
dc.identifier.uri https://hdl.handle.net/10161/19462
dc.description.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.
dc.language eng
dc.publisher Oxford University Press (OUP)
dc.relation.ispartof Open forum infectious diseases
dc.relation.isversionof 10.1093/ofid/ofz189
dc.subject clinical trials
dc.subject hepatitis C
dc.subject infectious disease
dc.subject policy
dc.title A Decade On: Systematic Review of ClinicalTrials.gov Infectious Disease Trials, 2007-2017.
dc.type Journal article
duke.contributor.id Chiswell, Karen|0330888
duke.contributor.id Tsalik, Ephraim L|0373391
dc.date.updated 2019-11-01T15:05:28Z
pubs.begin-page ofz189
pubs.issue 6
pubs.organisational-group Staff
pubs.organisational-group Duke
pubs.organisational-group Duke Clinical Research Institute
pubs.organisational-group Institutes and Centers
pubs.organisational-group School of Medicine
pubs.organisational-group Molecular Genetics and Microbiology
pubs.organisational-group Basic Science Departments
pubs.organisational-group Medicine, Infectious Diseases
pubs.organisational-group Medicine
pubs.organisational-group Clinical Science Departments
pubs.publication-status Published
pubs.volume 6
duke.contributor.orcid Chiswell, Karen|0000-0002-0279-9093
duke.contributor.orcid Tsalik, Ephraim L|0000-0002-6417-2042


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