Clinical data warehouse

A clinical data warehouse or CDW is a facility that houses all electronic data collected at a clinical center . For any modern clinical institute, it is necessary to separate operational data from informational data by creating a clinical data warehouse . A growing number of technologies for integrating and performing structured analyses of data from disparate sources are competing to win the day for healthcare organisations .

The TrialDB clinical study data management system of Nadkarni et al was the first to use multiple EAV (Entity-Attribute-Value model or Object-Attribute-Value Model or Open Schema) tables, one for each database management system (DBMS) data type. The EAV/CR (with Classes and Relationships) framework, designed primarily by Luis Marenco and Prakash Nadkarni , overlaid the principles of object-orientation on to EAV; it also built on Slezak's object table approach. Both TrialDB and EAV/CR are open-source, though they are built on Microsoft technologies rather than Java/Linux. In Oracle Clinical, a package for the management of clinical trials data; the clinical data component is stored in an EAV structure where all values are coerced to the varchar2 data type. Here a major DBMS vendor has decided that, despite all the difficulties and hazards of working with EAV, some circumstances make its use unavoidable.

The solution to warehousing the ever-changing structures of clinical data will require (a) a single, multi-trial repository based upon abstract rather than directly representational data models, and (b) adaptive, meta data-driven ETL (extract, transform and load) programming .

A virtual laboratory is a managed, networked collection of near patient and traditional laboratory instruments. It is Taylor et al's thesis that dramatic changes in the practice of laboratory medicine will emerge. Information from point-of-care devices and laboratories will be treated in a unified manner and all devices will become components of integrated internet connected virtual laboratories. Instruments will include devices located in traditional laboratories, such as complex multi-channel analyzers and specialty laboratory tests instruments, along with point-of-care devices located at a variety of sites including clinics and at patients’ homes. Virtual laboratories will combine the immediacy offered by point-of-care devices with services offered by traditional laboratories such as quality assessment, quality control, data capture, and the dissemination of results to patients and clinicians.

JANUS is a standards-based clinical data repository that utilizes the open source data model, Janus. Janus was created by FDA in partnership with IBM under a CRADA. This repository provides a data collection and analysis warehouse for clinical trial data submitted for protocols (what was supposed to happen) as well as clinical outcomes data (what did happen - events, interventions, etc.).