Using ClinicalTrials.gov to understand the state of clinical research in pulmonary, critical care, and sleep medicine.

Published

Journal Article

ClinicalTrials.gov is the largest trial registry in the world. Strengthened registration requirements, including federal mandates in 2007, have increased study representation. A systematic evaluation of all registered studies has been limited by the absence of an aggregate data set and specialty-specific search terms.We leveraged a newly transformed database containing annotated data from ClinicalTrials.gov to define the portfolio of interventional clinical research in pulmonary, critical care, and sleep medicine.Analysis was restricted to studies registered after September 2007 through September 2010 and defined as "interventional" (n = 40,970). A specialty-specific study data set (n = 2,226) was created using disease condition terms provided by data submitters and medical subject heading terms generated by a National Library of Medicine algorithm. Trial characteristics were extracted and summarized using descriptive statistics.Pulmonary, critical care, and sleep medicine trials composed 5.4% of all interventional studies registered over the 3-year period. In contrast, oncology and cardiovascular disease composed 21.9 and 8.4% of trials, respectively. Within pulmonary trials, asthma and chronic obstructive pulmonary disease were the most studied conditions (27.4 and 21.8% of studies, respectively), and measures of lung function or safety were the most frequent primary outcomes. Nearly two-thirds of trials indicated enrollment of 100 patients or fewer, and a majority of studies were phase II or III trials. The single largest funding source (43.5%) was industry, and study characteristics varied by funding source.We applied a novel approach to describe the portfolio of interventional clinical research in pulmonary medicine. Our results indicate a disparity between trial representation and the burden of respiratory disease. Resources should be targeted across the spectrum of pulmonary research to address this discrepancy.

Full Text

Duke Authors

Cited Authors

  • Todd, JL; White, KR; Chiswell, K; Tasneem, A; Palmer, SM

Published Date

  • October 2013

Published In

Volume / Issue

  • 10 / 5

Start / End Page

  • 411 - 417

PubMed ID

  • 23987571

Pubmed Central ID

  • 23987571

Electronic International Standard Serial Number (EISSN)

  • 2325-6621

International Standard Serial Number (ISSN)

  • 2329-6933

Digital Object Identifier (DOI)

  • 10.1513/AnnalsATS.201305-111OC

Language

  • eng