Goal
Derive and maintain, via quarterly updates, a relational database with publicly accessible datasets for aggregate analysis of the ClinicalTrials.gov content accompanied by supporting documents to inform the use of the data. This goal will facilitate the use of aggregate data in ClinicalTrials.gov to evaluate the state of the clinical trials system over time.

 

Why CTTI is doing a project on ClinicalTrials.gov
CTTI’s mission is to identify practices that through broad adoption will increase the quality and efficiency of clinical trials. To assess whether the clinical trial system is getting better or worse, a measurement method must be devised to identify and quantify successes and shortcomings. ClinicalTrials.gov—a legal entity managed by the National Library of Medicine—can provide CTTI with optimal means for achieving this goal by producing a valid snapshot of the clinical trial system’s functionality at any point in time.

ClinicalTrials.gov content is publicly available and can be downloaded directly from their website. To meet legal requirements, however, the data interface has been optimized for individual transactions. Although the definitions have been refined and the data fields have been improved in an iterative fashion, the entire dataset is difficult for naïve users to evaluate in an aggregate fashion.

 

Background on ClinicalTrials.gov
ClinicalTrials.gov is a registry of human clinical research studies hosted by the U.S. National Institutes of Health, through its National Library of Medicine (NLM), in collaboration with the Food and Drug Administration (FDA). Studies listed in the database are conducted in all 50 U.S. states and in 174 countries. The purpose of ClinicalTrials.gov is to provide a central resource for those seeking information on individual clinical research projects and to increase visibility of human subjects' research.

Federal law requires the registration of all trials of drugs and biologics, including controlled, clinical investigations other than phase I investigations of a product subject to FDA regulation, and trials of devices, including controlled trials with health outcomes of a product subject to FDA regulation (other than small feasibility studies) and pediatric postmarket surveillance studies. "Applicable clinical trials" generally include interventional studies (with one or more arms) of drugs, biological products, or devices that are subject to FDA regulation, meaning that the trial has one or more sites in the U.S., involves a drug, biologic, or device that is manufactured in the U.S. (or its territories), or is conducted under an investigational new drug application (IND) or investigational device exemption (IDE).

AACT - Database for Aggregate Analysis of ClinicalTrials.gov
CTTI has recently completed the first phase of a multi-phase project to make the acquisition and analysis of the aggregate data from ClinicalTrials.gov more user-friendly. Using data that were publicly available and downloaded from ClinicalTrials.gov, a restructured and reformatted relational database has been developed. The Oracle extracts from the AACT database are available in two formats for public download.

FAQ
A summary of the Frequently Asked Questions about this project and its products is available.

Results
Posters and publications associated with this project are available for viewing.

Team Organization

Financial and Other Support

Financial support provided by grant U19 FD003800 from the U.S. Food and Drug Administration. Personnel time has also been contributed by employees of the National Library of Medicine, a part of the National Institutes of Health.

Contact Information
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