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Data Integration – Implications in Pharmaceutical Industry
a report by
Akshay Rathi
The integration, analysis and reporting of data collected in clinical trials is one of the critical paths in drug development. Challenges arrive from integrating data from multiple sources. Furthermore, the analysis of this data must be controlled and must deliver reproducible results. Data from clinical trials are mined, cleaned, processed, reported and stored using appropriate computing tools. These tools support various aspects of the research process, such as trial design, data entry, source document tracking, data cleaning, analysis and reporting.
Problems arise when multiple data sources need to be shared. Often, problems linked to sharing data between different systems are addressed by several one-to-one links between the various systems. This results in considerable maintenance effort and version dependencies. Typically, data transformation and reporting programs are developed by copying files from a file system, which are then edited, possibly trial by trial. Managing version control and the testing cycle is a major challenge in such an environment. Accordingly, integrating data across the systems is time-consuming. Because data is dispersed, end-users cannot access crucial information without the involvement of a technically skilled person. Such delays during regulatory submission preparation are very costly.
In order to overcome this, a centralised Data Management System needs to be procured in the system. This system would project data in a structured manner such that it allows flexible study set-up and data entry. However, it is difficult to handle cross-trial data and to perform the sophisticated data transformations required for statistical analysis. Reporting and analysis are currently supported by some R/SAS-based systems. Using this, data managers and statisticians create their own tables, listings and figures for the reporting and analysis of clinical data. The analysed data are then collated and reported.
Data Mining
The need of the hour, right now is to develop a solution where data could be loaded by end-users from a variety of sources, where programs and reports could be built from a library of re-usable standards, and all authorised users could easily access the data they require. In addition, the automation of some of these processes would be an extra benefit. To achieve this, one needs to establish a unified environment for clinical data building, analysis and reporting at a global, cross-trial and individual trial level – effectively, a central global repository for data, which would integrate data from multiple sources.
Following this, it would need a user-friendly interface – the current data management system is often considered too complicated for non-technical personnel. The new system also needs to support regulatory requirements of US Food and Drug Administration (FDA).
Data Reporting
To allow clinical data reporting, programs must be created to transform, analyse and report data. One of the primary goals of such data integration is clinical data reporting, which is accomplished with the use of report sets. Company standard templates will be available for standard reports, such as clinical trial reports and other internal review reports. Visualisations provide easy and user-friendly access to data for data visualisations and exploratory data snooping by non-programmers.
The Benefits of Data Integration
In terms of business benefits, having one central global data repository will be the biggest benefit. As any global company, with clinical studies running all over the world would have data in several locations. With such data integration we can put all data in one place, which gives the end-user an opportunity to reuse programs, further facilitate the use of standards and reduce cost and time for the development of programs.
1. The eClinical Equation: Delivering the Vision, Touch Briefings/IBM
Akshay Rathi is an Instrumentation Engineer working at Emerson Export Engineering Centre, Pune. He is good at learning new technologies and applying them in industry for benefits of organisation. Akshay has been following trends in Pharmaceutical industry and aims to invest his automation expertise to develop solutions that would help bring revolutions in the industry. In this case he wishes to help drug development by providing him Data Integration solution that would enable research scientists in easy computation, 360° visibility of statistical data and accurate decision making, in turn speeding up research processes for the benefit of humankind.
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