Clinical Trials Network (CTN) Data Share
To date, the efficacy of new treatments for drug addiction has been demonstrated primarily in specialized research settings, with somewhat restricted patient populations. To address this problem, the National Institute on Drug Abuse (NIDA) established the National Drug Abuse Treatment Clinical Trials Network (CTN).
The CTN encourages investigators interested in drug abuse to use the CTN’s clinical trials database to promote research. This site allows researchers to download de-identified data from completed CTN studies to conduct analyses that improve the quality of drug abuse treatment.
Purpose
The Clinical Trials Network (CTN) Data Share web site is an electronic environment that allows data from completed clinical trials to be distributed to investigators in order to promote new research, encourage further analyses, and disseminate information to the community. Secondary analyses produced from data sharing multiply the scientific contribution of the original research.
Effective data sharing includes communicating to the research community that data are available, providing sufficient descriptive information about the data, enforcing compliance to standard semantics and structure, rendering the data in a usable format, and making data accessible.
Protection of Human Subjects
Our primary concern in sharing data is the protection of human subjects. The rights and privacy of people who participate in NIH-sponsored research must be protected at all times. Thus, data on this site have been completely de-identified to prevent linkages to individual research participants. This includes removal of all Personal Health Information (PHI) and indirect identifiers that are not listed as PHI but could lead to "deductive disclosure" such as comment fields and site numbers. Study-specific de-identification methods are documented with each protocol.
Data Formats
Data are available in either a Clinical Data Interchange Standards Consortium (CDISC) format or a Case Report Form (CRF) format. For some studies, both formats are available. For the CDISC format, prior to de-identifying the data, all data files are converted from their native format to a modified Study Data Tabulation Model (SDTM) standard format. The SDTM is a content standard sponsored by CDISC. This universal data format will be applied to each completed CTN trial's data. This will facilitate the pooling of shared data across completed studies, as the variable names are consistent across studies. For the CRF format, separate data files are created for each CRF collected on the study. This will facilitate those researchers interested in looking at all data from a single CRF in one data file, as the data files match the CRF exactly.
De-identified data are available for download in two formats: SAS (transport files) and ASCII (CSV files). Documentation regarding the data and corresponding study that generated the data are also available under each completed protocol page. This includes the annotated case report form (CRF); a define.xml file outlining the structure, variables and contents of each dataset; and SDTM mapping for the CDISC data and de-identification rules.
Disclaimer: The trial data sets available on this NIDA Clinical Trials Data Share website are derived from the complete trial database. Analysis data sets such as those utilized to develop publications are not included on this website. Please see the primary manuscript or contact the investigator for details.
Registration
Prior to downloading any study data, the user will be prompted to complete a registration agreement for data use. Users will have to register a name, position, affiliation, valid email address, and country of origin in order to download data to accept their responsibility for using data in accordance with the CTN Data Share Agreement.
Availability
Data for completed protocols will be available to the public approximately 18 months after completion of the study or after the acceptance of publication of the primary manuscript, whichever occurs first.