JANUS clinical trial data repository
Encyclopedia
Janus clinical trial data repository is a clinical trial
data repository (or data warehouse
) standard as sanctioned by the U.S. Food and Drug Administration (FDA). It was named for the Roman god Janus (mythology)
, who had two faces, one that could see in the past and one that could see in the future. The analogy is that the Janus data repository would enable the FDA and the pharmaceutical industry to both look retrospectively into past clinical trials, and also relative to one or more current clinical trials (or even future clinical trials thru better enablement of clinical trial design).
The Janus data model
is a relational database
model, and is based on SDTM
as a standard, in terms of many of its basic concepts such as the loading and storing of findings, events, interventions and inclusion data. However, Janus itself is a data warehouse independent of any single clinical trials submission standard. For example, Janus can store pre-clinical trial (non-human) submission information as well, in the form of the SEND non-clinical standard.
The goals of Janus are as follows:
Clinical trial
Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for health interventions...
data repository (or data warehouse
Data warehouse
In computing, a data warehouse is a database used for reporting and analysis. The data stored in the warehouse is uploaded from the operational systems. The data may pass through an operational data store for additional operations before it is used in the DW for reporting.A data warehouse...
) standard as sanctioned by the U.S. Food and Drug Administration (FDA). It was named for the Roman god Janus (mythology)
Janus (mythology)
In ancient Roman religion and mythology, Janus is the god of beginnings and transitions, thence also of gates, doors, doorways, endings and time. He is usually a two-faced god since he looks to the future and the past...
, who had two faces, one that could see in the past and one that could see in the future. The analogy is that the Janus data repository would enable the FDA and the pharmaceutical industry to both look retrospectively into past clinical trials, and also relative to one or more current clinical trials (or even future clinical trials thru better enablement of clinical trial design).
The Janus data model
Data model
A data model in software engineering is an abstract model, that documents and organizes the business data for communication between team members and is used as a plan for developing applications, specifically how data is stored and accessed....
is a relational database
Relational database
A relational database is a database that conforms to relational model theory. The software used in a relational database is called a relational database management system . Colloquial use of the term "relational database" may refer to the RDBMS software, or the relational database itself...
model, and is based on SDTM
SDTM
SDTM defines a standard structure for human clinical trial data tabulations that are to be submitted as part of a product application to a regulatory authority such as the United States Food and Drug Administration...
as a standard, in terms of many of its basic concepts such as the loading and storing of findings, events, interventions and inclusion data. However, Janus itself is a data warehouse independent of any single clinical trials submission standard. For example, Janus can store pre-clinical trial (non-human) submission information as well, in the form of the SEND non-clinical standard.
The goals of Janus are as follows:
- To create an integrated data platform for most commercial tools for review, analysis and reporting
- Reduce the overall cost of existing information gathering and submissions development processes as well as review and analysis of information
- Provide a common data model that is based on the SDTM standard to represent four classes of clinical data submitted to regulatory agencies: tabulation datasets, patient profiles, listings, etc.
- Provides central access to standardized data, and provide common data views across collaborative partners.
- Support cross-trial analyses for data mining and help detect clinical trends and address clinical hypotheses, and perform more advanced, robust analysis. This will enable the ability to contrast and compare data from multiple clinical trials to help improve efficacy and safety.
- Facilitate a more efficient review process and ability to locate and query data more easily through automated processes and data standards.
- Provide a potentially broader data view for all clinical trials with proper security, de-identified patient data, and proper agreements in place to share data.
External links
- http://www.fda.gov/ForIndustry/DataStandards/StudyDataStandards/ucm155327.htm
- http://gforge.nci.nih.gov/docman/?group_id=142
- http://gforge.nci.nih.gov/docman/index.php?group_id=180
- http://crix.nci.nih.gov/projects/janus/