ClinicalTrials.gov

Abstract

Since 2007, the US federal government has required that organizations sponsoring clinical trials with a least one site in the United States submit information on these clinical trials to an existing database: ClinicalTrials.gov. Over time, the number of mandatory variables has grown and will probably continue to grow. The database now represents an important source of descriptive information about the landscape for clinical trials. In addition, it constitutes a rich pool of data to test hypotheses—for instance, what variables are associated with an organization’s ability to correctly estimate study completion times or complete those studies in as short a time frame as possible. This paper concludes that for mandated variables that the authors have labeled study identification, protocol and study design, and study execution, the data set constitutes a potentially very valuable research resource. With the exception of some site-related information, incomplete data did not exceed 3%. The incomplete site data are concentrated in several companies, so it is not unreasonable to assume that those data will also become more complete.