CTTI’s State of Clinical Trials Project set out to facilitate the analyses of data in ClinicalTrials.gov, by creating the database for Aggregate Analysis of ClincalTrials.gov (AACT), a restructured and reformatted relational database developed using publicly available and downloadable data from ClinicalTrials.gov. Since the original AACT was created in 2010, we’ve continued to regularly issue updated versions of the database.

The latest version of the AACT Database is now available on the CTTI website, along with the supporting documents. This dataset reflects data downloaded from ClinicalTrials.gov in September 2014. To assist users with interpretation of the data, high level and comprehensive data dictionaries and a points to consider document are also located on the CTTI website. Previous versions of AACT are available as well.

We are pleased to announce that new features to assist usability accompany the most recent AACT Database. Please see the Points to Consider Document for more details. These features include:

• An additional “readme” document is included in the pipe-delimited text files zip file for users who plan to work with the data extracts in the R statistical computing environment.
• A target duration (e.g. 180 Days) variable is now included for records where the STUDY_TYPE=”Observational [Patient Registry]”.
• New “Delayed Results” data elements are included in the pipe-delimited text files and SAS CPORT transport files. This includes a list of studies, provided by the National Library of Medicine, that had submitted a certification or extension request to the 12-month results reporting requirement before September 27, 2014, and the date of the first certification or extension request. For further details, refer to the “readme” documents within the zip files.

Since CTTI released the first AACT database, it has been utilized to answer many questions regarding the landscape of clinical trials. For a list of peer-reviewed publications that have assessed the state of trials within medical specialties, CLICK HERE.

Peripheral Vascular Disease (PVD) poses a growing public health concern, particularly for the aging American population. While a high prevalence of vascular disease exists, and therapeutic advances have been made in this area, a systematic overview of the clinical trials portfolio for PVD has not been done, until recently.

A new Circulation publication, titled Clinical Trials in Peripheral Vascular Disease: Pipeline and Trial Designs: An Evaluation of the ClinicalTrials.gov Database, utilized the CTTI-created AACT Database, a searchable relational database of content from ClinicalTrials.gov. The AACT Database allowed researchers to analyze interventional trials registered in ClinicalTrials.gov from October 2007 through September 2010 (n=40,970).

The author’s conclude,

PVD studies represent a small group of trials registered in ClinicalTrials.gov, despite the high prevalence of vascular disease in the general population. This low number, compounded by the decreasing number of PVD trials in the United States, is concerning and may limit the ability to inform current clinical practice of patients with PVD.*

To view the article online, CLICK HERE.

 

*Source: Sumeet Subherwal, Manesh R. Patel, Karen Chiswell, Beth A. Tidemann-Miller, W. Schuyler Jones, Michael S. Conte, Christopher J. White, Deepak L. Bhatt, John R. Laird, William R. Hiatt, Asba Tasneem, and Robert M. Califf, “Clinical Trials in Peripheral Vascular Disease: Pipeline and Trial Designs: An Evaluation of the ClinicalTrials.gov Database,” Circulation, (Sept 19 2014).

In an effort to characterize the U.S. clinical trials enterprise, CTTI’s State of Clinical Trials Project set out to facilitate the analyses of data in ClinicalTrials.gov, a registry of human clinical research studies hosted by the U.S. National Institutes of Health (NIH) in collaboration with the FDA. The result of this project was the Aggregate Analysis of ClincalTrials.gov (AACT) Database, a restructured and reformatted relational database developed using publicly available and downloadable data from ClinicalTrials.gov. Since the original AACT was created in 2010, we’ve continued to regularly issue updated versions of the database.

The latest version of the AACT Database is now available on the CTTI website, along with the supporting documents. This dataset reflects data downloaded from ClinicalTrials.gov in March 2014. To assist users with interpretation of the data, a high level dictionary and a points to consider document are also located on the CTTI website. Previous versions of AACT are available as well.