Challenges in Clinical Data Archiving

By

Dr. Vikram Venkateswaran
Senior Business Consultant
CSC-iSoft NHS
Covansys-A CSC Company
Unit 13, Block 2, SDF Buildings, MEPZ, Chennai-600045
 

Archiving refers to the process of recording all past versions of a database, in order to verify findings based upon a specific version. (Buneman, Khanna, Tajima, and Tan ACM transactions on Database systems Vol 20).This is important in the scientific world as it allows the creation of a data archive that allows scientific researchers to review records constantly, delete irrelevant data and add the new findings to the existing data.

In the process of drug development this has additional implications as a lot of data is generated, especially in the process of clinical trials. The presence of an archive allows the drug researchers to verify that the reports published by the drug companies, accurately reflect the data. Internal uses of data archives keep changing as the industry is dynamic withy changes in software and knowledge and information sharing techniques improving constantly. There is need for archiving as the clinical trial generated scientific information needs to be kept for long periods for a number of reasons: internal use, to comply with regulatory framework, usage in patient intellectual property rights disputes, contract disputes and product liability among others. (Scientific Computing World December 2005). The recent interest from the drug companies and laboratory research firms towards Electronic laboratory Notebooks(ELN) has opened up a new paradigm in Archiving, as the need to capture research data real time electronically has unexpectedly high lightened the process how the pharmaceutical companies archive their data. To add to this is the challenge of maintaining the archive which falls on the producers of the data, but there are no standardised techniques for efficiently maintaining the data that would enable retrieval of an artifact or the ability to trace the evolution of the data. Another important challenge is to keep a record of the changes or 'delta' in order to keep track of the transition from one data form to another.

To overcome these challenges experts have suggested many techniques like the usage of Annotate Keys, Usage of Nested Merge Techniques and the usage of Keys both for recording the changes and for merging the various versions. But the biggest challenge in Clinical Data Archiving remains the transition and tracing the evolution of historical data. It seems two popular methods have emerged, the incremental difference approach that stores the first version and differences of every successive pairs of versions in a repository, and the cumulative difference approach that stores the first version and differences of every version from the first version. (Buneman, Khanna, Tajima, and Tan ACM transactions on Database systems Vol 20)

At the Tuberculosis Research Centre(TRC) in Chennai the Clinical Data Archive is still maintained manually using paper records, while the Clinical Trial management system called 'Study 23' implemented by Covansys is used for electronic data capture and then publication of report. The only electronically maintained records have been the radiographs which are scanned and then archived. The current challenge that TRC is facing is Migration of the Paper records to electronic archive without losing track of the records which demonstrate the evolution of their research findings. Though the challenges in Archiving clinical data remain, the advantages of a data archive is the key factor driving researcher's world wide to find a solution to these challenges.
 

Dr. Vikram Venkateswaran
Senior Business Consultant
CSC-iSoft NHS
Covansys-A CSC Company
Unit 13, Block 2, SDF Buildings, MEPZ, Chennai-600045
 

Source: E-mail October 23, 2007

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