The State of Infectious Diseases Clinical Trials: A Systematic Review of ClinicalTrials.gov

• Published in: PloS one Vol. 8; no. 10; p. e77086
• Main Authors: Goswami, Neela D., Pfeiffer, Christopher D., Horton, John R., Chiswell, Karen, Tasneem, Asba, Tsalik, Ephraim L.
• Format: Journal Article
• Language: English
• Published: United States Public Library of Science 16.10.2013; Public Library of Science (PLoS)
• Subjects: Acquired immune deficiency syndrome; AIDS; AIDS vaccines; Cardiovascular agents; Clinical trials; Clinical Trials as Topic - history; Clinical Trials as Topic - statistics & numerical data; Communicable Disease Control - statistics & numerical data; Communicable diseases; Communicable Diseases - diagnosis; Communicable Diseases - mortality; Communicable Diseases - therapy; Data dictionaries; Datasets; Evidence-based medicine; Global Health; Health aspects; Hepatitis; Hepatitis C; Hepatitis C virus; History, 21st Century; HIV; Human immunodeficiency virus; Humans; Infectious diseases; Influenza; Influenza vaccines; Information systems; Joint surgery; Medical research; Medicine; Mental disorders; Mental health; Mortality; Product development; Public health; Registration; Registries; Respiratory tract; Respiratory tract diseases; Studies; United States; Viruses; Web sites; Websites; North Carolina; Oregon; United States > US
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0077086

There is a paucity of clinical trials informing specific questions faced by infectious diseases (ID) specialists. The ClinicalTrials.gov registry offers an opportunity to evaluate the ID clinical trials portfolio. We examined 40,970 interventional trials registered with ClinicalTrials.gov from 2007-2010, focusing on study conditions and interventions to identify ID-related trials. Relevance to ID was manually confirmed for each programmatically identified trial, yielding 3570 ID trials and 37,400 non-ID trials for analysis. The number of ID trials was similar to the number of trials identified as belonging to cardiovascular medicine (n = 3437) or mental health (n = 3695) specialties. Slightly over half of ID trials were treatment-oriented trials (53%, vs. 77% for non-ID trials) followed by prevention (38%, vs. 8% in non-ID trials). ID trials tended to be larger than those of other specialties, with a median enrollment of 125 subjects (interquartile range [IQR], 45-400) vs. 60 (IQR, 30-160) for non-ID trials. Most ID studies are randomized (73%) but nonblinded (56%). Industry was the funding source in 51% of ID trials vs. 10% that were primarily NIH-funded. HIV-AIDS trials constitute the largest subset of ID trials (n = 815 [23%]), followed by influenza vaccine (n = 375 [11%]), and hepatitis C (n = 339 [9%]) trials. Relative to U.S. and global mortality rates, HIV-AIDS and hepatitis C virus trials are over-represented, whereas lower respiratory tract infection trials are under-represented in this large sample of ID clinical trials. This work is the first to characterize ID clinical trials registered in ClinicalTrials.gov, providing a framework to discuss prioritization, methodology, and policy.