CDISC plans India Committee for standardising clinical data

Balakrishnan Nair - Mumbai

The Clinical Data Interchange Standards Consortium (CDISC), in an effort to formalise its global representation, is planning to form an India-CDISC Co-ordinating Committee on the lines of Europe CDISC Co-ordinating Committee (ECCC) and Japan CDISC Co-ordinating Committee (JCCC) to develop and support global data standards that enable information system interoperability to improve medical research and related areas of healthcare.

Speaking to Express Pharma Pulse at an awareness programme organised by Tata Consultancy Services recently here, Frank T Newby, vice-president, education and member relations, CDISC said ‘‘Toward this, we are meeting the representatives of Indian drug control authority and the

pharmaceutical industry to seek their membership into CDISC. Tata Consultancy Services (TCS) will be the first Indian member of ICCC’’

‘‘The CDISC members and sponsors are primarily global companies including biotech and pharmaceutical companies, technology and services providers, academic centres and others interested in working together to streamline clinical trials through the development of standards. We already have regional CDISC groups in Japan, Europe and other regions who are bringing together interested parties to support local needs within the realm of the global CDISC organisation,’’ he added.

Explaining the data models, he said ‘‘The CDISC data models support the data flow of clinical trials, from the source into an operational database, through analysis to regulatory submission. The sources of data that are relevant to CDISC vary among patient records, clinical laboratory data, data from contract research organisations, shared data between companies with corporate mergers or development partners and other sources. While operational data modelling (ODM) is the standard data interchange models that support the data acquisition, interchange and archiving of operational data, submission data modelling (SDM) is the standard metadata models support the data flow from the operational database to regulatory submission.’’

‘‘The CDISC standard for the exchange of clinical trial laboratory data is now approved by US FDA as an HL7 Reference Information Model, in addition to the original ASCII, SAS and XML implementation options,’’ he informed.

‘‘The use of the CDISC standards shall enable the US FDA to employ a standard set of review tools. This will substantially improve the current process because it will facilitate their work as well as expand their review capabilities, such as analysing cross-trial databases,’’ he claimed.

Other activities of CDISC activities closely aligned with FDA activities, include laboratory data standards, standards to support data acquisition and archive, and metadata standards. The CDISC activities are also getting increased attention from analogous regulatory organisations in other countries.

The consortium at present has around 165 corporate members and is continuing to make progress towards its goal of creating a global, harmonised CDISC standard through the concerted efforts of its many participating volunteers, said Julie Evans, manager technical services, CDISC.