Data Available for Sharing

Background

Since the AACT database was launched in 2010, dozens of researchers have used it to better understand the state of clinical trials. Investigators have used AACT to study 'results reporting trends' to determine how compliant the research community has been with federally mandated regulations. Others have used AACT to find out which conditions & interventions tend to receive the most attention, which appear to be neglected, and how specific types of trials are distributed geographically.

Several AACT-based investigations have produced datasets, such as curated sets of condition terms used to identify a particular subset of studies. Providing access to this analytic data allows others interested in similar topics, or those who would like to further analyze or verify the investigations, to benefit and build upon the previous work.

Shared Data Available in AACT

To facilitate public sharing of curated data resources between AACT users, we're making project datasets available within the AACT database. Each project has its own database schema that encapsulates the curated data the project's principal investigator has shared with us. Users of the live AACT database can query the project data and/or ClinicalTrials.gov data that resides in the main AACT schema: ctgov. They may join data across different schemas. In short, project information is kept structurally separate from ClinicalTrials.gov data, but the information is also integrated within the same database so it can be used in combination with current trial data.

The name of each project's database schema is identified in the table below. Click on a row to view more details & access downloadable versions of datasets and data definitions.

CDEK’s Standard Organization Names

Published:2018
Clinical Drug Experience Knowledgebase (CDEK) is a database and web-platform to enable researchers and analysts to study all active pharmaceutical ingredients with evidence of clinical experience in humans. CDEK contains over 20,000 active pharmaceutical ingredients with surrounding annotated metadata (i.e. sponsoring organizations, indications, clinical trial data, chemical structure, etc). The Washington University team curated CDEK in part by disambiguating intervention and organization names from ClinicalTrials.gov (through AACT). This information was cross-referenced against entries in prominent international drug databases (e.g. PubChem, ChEMBL, DrugBank). The prototype web-application is designed to allow researchers of all backgrounds to access and query the data. It can be found at cdek.wustl.edu. Organizations are often identified by a variety of names in ClinicalTrials.gov, making it difficult to correctly identify all studies associated with an organization. For example, ‘Washington University-St. Louis' and ‘Washington University School of Medicine' are both considered “Washington University in St. Louis”. In fact, Washington University in St. Louis and its schools/institutes, are represented 63 different ways in ClinicalTrials.gov. The CDEK curation process currently focuses on organizations/affiliations identified as the sponsor, overall official or responsible parties for drug intervention trials in ClinicalTrials.gov as of September, 2017. (Organizations in the 'facilities' table were not included.) Each organization name was assigned a standardized 'preferred' (or parent) name, effectively creating an index of names that map the variety of names to a common name, making it easier to group studies by organization. The organization information curated for the CDEK project is now available in AACT.

Characteristics of Clinical Trials Registered in ClinicalTrials.gov, 2007-2010

Published:2012
This project used ClinicalTrials.gov data to summarize characeristics of 40,970 interventional trials registered between October 2007 and September 2010. Characteristics were compared between trials in three clinical specialties: mental health, cardiovascular and oncology.

Compliance with Results Reporting at ClinicalTrials.gov

Published:2015
From published Abstract: From all the trials at ClinicalTrials.gov, we identified 13,327 HLACTs that were terminated or completed from January 1, 2008, through August 31, 2012. Of these trials, 77.4% were classified as drug trials. A total of 36.9% of the trials were phase 2 studies, and 23.4% were phase 3 studies; 65.6% were funded by industry. Only 13.4% of trials reported summary results within 12 months after trial completion, whereas 38.3% reported results at any time up to September 27, 2013. Timely reporting was independently associated with factors such as FDA oversight, a later trial phase, and industry funding. A sample review suggested that 45% of industry-funded trials were not required to report results, as compared with 6% of trials funded by the National Institutes of Health (NIH) and 9% of trials that were funded by other government or academic institutions.

The Landscape of Clinical Trials in Nephrology: A Systematic Review of ClinicalTrials.gov

Published:2014
A systematic review of interventional (ie, nonobservational) studies (both randomized and nonrandomized) registered between October 2007 and September 2010 were included for analysis. Studies were reviewed independently by physicians and classified by clinical specialty.

Please Note...

  • Project data are available in the live AACT database hosted at aact-db.ctti-clinicaltrials.org. Static copies of the database and pipe-delimited filesets available for download contain only ClinicalTrials.gov data; they do not include project information.

  • Files containing data element definitions (defining project-specific tables & columns) are available for download for some projects in the 'Other Attachments' section.

  • Currently, AACT includes analytic information for four AACT-based projects that CTTI determined will likely benefit the largest audience. Many other investigators have analyzed ClinicalTrials.gov data. CTTI intends to continue to add curated & analytic data from past and future research to further enhance this resource.