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.

Name	Investigators	Organizations	Publication Year	Brief Summary	DB Schema
CDEK’s Standard Organization Names	Rebekah Griesenauer, PhD, Postdoctoral Scholar; Michael S Kinch, PhD, Associate Vice Chancellor	Washington University - St. Louis. Center for Research Innovation and Biotechnology	2018	The CDEK project at Washington University has curated organization data to begin standardizing this terminology. Because an organization may be identified several different ways in ClinicalTrials.gov, it's often difficult to accurately identify all studies associated with an organization. Washington University has creating a queryable 'organization index' that provides a way for AACT users to more easily identify all studies associated with an organization.	proj_cdek_standard_orgs
Description 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. Publication Griesenauer R, Schillebeeck C, Kinch MS. CDEK: Clinical Drug Experience Knowledgebase. bioRxiv The Preprint Server for Biology. 2018 November 19 Downloadable Datasets CDEK Standardized Organization Names (Available in AACT database: proj_cdek_standard_orgs.cdek_organizations) CDEK Organization Synonyms (Available in AACT database: proj_cdek_standard_orgs.cdek_synonyms) Other Attachment Data Definitions See more info ...
Characteristics of Clinical Trials Registered in ClinicalTrials.gov, 2007-2010	Robert M. Califf, MD; Deborah A. Zarin, MD; Judith M. Kramer, MD, MS; Rachel E. Sherman, MD, MPH; Laura H. Aberle, BSPH; Asba Tasneem, PhD	Duke Clinical Research Institute	2012	The objective was to examine fundamental characteristics of interventional clinical trials registered in the ClinicalTrials.gov database.	proj_tag_study_characteristics
Description 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. Publication Califf RM, Zarin DA, Kramer JM, Sherman RE, Aberle LH, Tasneem A. Characteristics of clinical trials registered in ClinicalTrials. gov, 2007-2010. Jama. 2012 May 2;307(17):1838-47. Downloadable Datasets Analyzed Studies (Available in AACT database: proj_tag_study_characteristics.) This 4-page spreadsheet identifies all studies that were analyzed in this investigation. The NCT ID, brief title and lead sponsor are the data elements provided. The first page of the spreadsheet lists all studies with three yes/no columns to indicate which of the three clinical specialties each study belongs. Three additional pages are included that list studies by clinical specialty. The AACT database provides this information in three tables in the proj_tag_study_characteristics schema, one table per clinical specialty: mental_health_studies, oncology_studies and cardiovascular_studies. You can use the NCT ID to join to current study information available in the ctgov schema. (It should be noted that information may have been updated since this investigation concluded.) Trials selected from AACT that are indentified as having focused on one of three clinical specialties: cardiovascular, mental health, and/or oncology and registered in ClinicalTrials.gov between September, 2007 and September 27, 2010. (These three clinical specialties together encompass the largest number of disability-adjusted life-years lost in the United States). Analyzed MeSH & Free Text Terms & Those Associated with Mental Health, Oncology and Cardiovascular (Available in AACT database: proj_tag_study_characteristics.tagged_terms) This 5-page spreadsheet includes information about the MeSH & free text terms that were analyzed to determine which are associated with mental health, oncology or cardiovascular specialties. The first page lists all analyzed MeSH terms (and MeSH IDs) and three Y/N columns to show if the term was determined to be associated with a clinical specialty. The second page does the same for the free text terms. Three other pages: mental health, oncology and cardiovascular, provide a unique list of MeSH & free text terms associated with that specialty. Some terms are associated with more than one clinical specialty. For example, 'Carcinoid Heart Disease' is associated with both oncology and cardiovascular. The MeSH terms are those from the 2010 MeSH thesaurus branches C, E, F, G that relate to either mental health, oncology or cardiovascular conditions. The free text terms are those related to one of these 3 specialties that occurred in AACT(2010).conditions field with frequency >=5 among interventional studies registered on or after Oct 1, 2007, and that did not exist in MeSH thesaurus. Other Attachment Data Definitions AACT Version: September 27, 2010 See more info ...
Compliance with Results Reporting at ClinicalTrials.gov	Monique L. Anderson, M.D., Karen Chiswell, Ph.D., Eric D. Peterson, M.D., M.P.H., Asba Tasneem, Ph.D., James Topping, M.S., and Robert M. Califf, M.D.	Duke Clinical Research Institute	2015	Analysis of the levels & patterns of compliance with FDAAA reporting regulations for trials conducted between 2008 & 2013 (considering only those trials that are highly likely to be applicable to FDAAA provisions).	proj_results_reporting
Description 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. Publication Anderson ML, Chiswell K, Peterson ED, Tasneem A, Topping J, Califf RM. Compliance with results reporting at ClinicalTrials. gov. New England Journal of Medicine. 2015 Mar 12;372(11):1031-9. Downloadable Dataset Analyzed Studies (Available in AACT database: proj_results_reporting.analyzed_studies) Trials selected from AACT by applying algorithm to identify trials highly likely to be 'Applicable Clinical Trials' (see table S1 in supplemental material to manuscript). Other Attachment Data Definitions AACT Version: September 27, 2013 See more info ...
The Landscape of Clinical Trials in Nephrology: A Systematic Review of ClinicalTrials.gov	Jula K. Inrig, MD,1,2 Robert M. Califf, MD,1 Asba Tasneem, PhD,1 Radha K. Vegunta, MD,3 Christopher Molina, BS,4 John W. Stanifer, MD,1 Karen Chiswell, PhD,1 and Uptal D. Patel, MD1	Duke Clinical Research Institute	2014	While conducting a systematic review of nephrology-related studies in ClinicalTrials.gov, the investigators tagged nephrology-related MeSH & free-text condition terms. Interventional studies registered between Oct 1, 2007 & September 27, 2010 with conditions, browse_conditions or keywords that matched any of the terms tagged as 'nephrology' were reviewed by investigators, to create the final subset of studies included in the analysis.	proj_tag_nephrology
Description 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. Publication Inrig JK, Califf RM, Tasneem A, Vegunta RK, Molina C, Stanifer JW, Chiswell K, Patel UD. The landscape of clinical trials in nephrology: a systematic review of Clinicaltrials. gov. American Journal of Kidney Diseases. 2014 May 1;63(5):771-80. Downloadable Datasets Nephrology Terms (MeSH & Free Text) (Available in AACT database: proj_tag_nephrology.tagged_terms) 83 unique MeSH condition terms & 31 unique free text condition terms tagged for nephrology The MeSH terms are from the 2010 MeSH thesaurus, terms in branches C, E, F, G. The free text terms are those that occurred in AACT(2010).Conditions field with frequency >=5 among interventional studies registered on or after Oct 1, 2007, and that did not exist in MeSH thesaurus. Analyzed Studies (Available in AACT database: proj_tag_nephrology.analyzed_studies) From AACT(2010), subset on 40,970 interventional studies registered on or after October 1, 2007. Searched for studies with nephrology-specific terms in AACT(2010).Conditions, OR AACT(2010).Keywords, OR AACT(2010).MeSH_Trees (where MeSH_Type='condition). Investigators then reviewed the resulting list of studies and identified the final cohort of 1054 nephrology trials reported in the manuscript. AACT Version: September 27, 2010 See more info ...

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.