Using publicly available and downloadable data from ClinicalTrials.gov, a restructured and reformatted relational database was developed. This is referred to as the database for Aggregate Analysis of ClincalTrials.gov (AACT). The purpose of AACT is to make the acquisition and analysis of the aggregate data from ClinicalTrials.gov more user-friendly. CLICK HERE for an overview of the background on ClinicalTrials.gov and the AACT database.
The Oracle extracts from the AACT database are available in three formats. ZIP files containing these database extracts may be downloaded from the links provided below:
- Oracle dmp
- Pipe delimited text output
- SAS CPORT transport
*This dataset reflects data downloaded from ClinicalTrials.gov September 27, 2013.
**The Readme file (located in each ZIP file) provides critical considerations for database administrators and statistical programmers regarding importing the database extracts.
2013 Supporting Documents
- The Comprehensive Data Dictionary 2013 provides a complete list of data elements from the AACT database, corresponding definitions from NLM’s data element definitions document, and data model and parameters used in the AACT database. It is designed for data analysts and programmers and contains following six sections: current variables, enumerations, schema, constraints, requirements, and record counts.
- The High Level Data Dictionary 2013 delivers a summary view of the variables contained in the AACT database and is designed for investigators and researchers. Users may also wish to access the protocol data element definitions and results data element definitions as posted on the ClinicalTrials.gov Protocol Registration System site; these documents provide some information related to the branching nature of the registration and results questions.
Points to Consider When Using AACT 2013
The Points to Consider Document provides guidelines for investigators to consider when planning a statistical analysis of the ClinicalTrials.gov database. It is not intended to be a comprehensive guide. See document for information on:
- Population: which studies are likely to be represented in the ClinicalTrials.gov registry
- Duplicate records
- Data completeness and accuracy
- Types of questions that can be investigated with the ClinicalTrials.gov data from AACT
- ClinicalTrials.gov data element definitions and interpretation of these variables
- Explanation of variables original to ClinicalTrials.gov ("National Library of Medicine (NLM)" variables) and those added as a part of the AACT database ("CTTI" variables)
- Integration of the MeSH thesaurus (NLM's controlled vocabulary thesaurus) into the AACT database
Previous Versions of AACT are available here:
Dataset reflects data downloaded from ClinicalTrials.gov September 27, 2012.
Dataset reflects data downloaded from ClinicalTrials.gov September 27, 2011.
Dataset reflects data downloaded from ClinicalTrials.gov September 27, 2010.