Successful Demonstration of Standard Operational Data Interchange Model
for the Biopharmaceutical Industry

On 10 July 2001, 22 companies collaborated in a unique event to demonstrate that they could exchange data between their systems using a standard data model developed through the Clinical Data Interchange Standards Consortium (CDISC). Each year, the industry spends millions* of dollars and, more importantly, uses valuable time on activities directly related to data exchange between the biopharmaceutical companies and CROs or technology providers. Not included in this estimate are the costs of data integration and standards development resulting from recent mergers among major pharmaceutical companies, and the costs associated with clinical laboratory data transfers between clinical laboratories and pharmaceutical companies or CROs. As a basis for the CDISC efforts, it is assumed that a standard data interchange model would not only significantly reduce the data exchange costs and time, but more importantly, it will pave the way for a number of industry requirements leading to the search for more safe and efficient ways to conduct clinical trials.

The CDISC Clinical Data Connectathon was viewed as a proof-of-concept for the CDISC operational data model, an XML-based model developed to support the exchange of data acquired from different sources into an operational database. Each participating company was provided a ‘Test Kit’, consisting of a) data from a small, but complete clinical trial; b) Version 1.0 of the CDISC model in XML; c) use case scenarios; d) instructions on how to execute the requested test; e) an viewer they could opt to use; and f) an evaluation form. The test required that the test data be imported into a participant’s system, and there was an optional step to also export the data. Of the twelve participating companies that completed the evaluation form, three did just the import part of the test and nine did both import and export in an integrated test. We were extremely pleased that certain participants went ‘over and above’ the test requirements. In fact, one pharmaceutical company (GlaxoSmithKline) connected with a CRO (Cato), and one technology/applications provider (Clinsoft) connected with three other companies: CRF Box, Perceptive Informatics and iBiomatics (a SAS Company). [Please see the Who’s Who Document specifying each participant and their Connectathon-related activities.]

In summarizing evaluation comments from participants, lessons learned include:

CDISC upholds certain principles in their standards development efforts within the biopharmaceutical industry. These include adherence to and comprehension of the scientific integrity and uniqueness of each clinical trial, in addition to ensuring that the standards are platform-independent and vendor-neutral. Although the concept has now been proven, CDISC has much work yet to accomplish. Next steps include the following.

1) The Operational Data Model (ODM) tested was Version 1.0, which was released for review by the CDISC ODM Team in October of 2000. This team is very close to releasing Version 1.1 of the ODM model. This will be posted on the CDISC website and review comments will be solicited, through that site and also from an external review team.

2) There is another CDISC team that is dealing specifically with a data interchange standards to support clinical laboratory data. This LAB team is documenting the requirements in detail, and the model should ultimately be compatible with the ODM model and the modeling of the HL7 organization.

3) A new version of the safety domain metadata models for electronic submissions was submitted to FDA in October 2000. The FDA is reviewing these models in the context of a future Guidance Document that they plan to release on CRTs to support e-Submissions.

4) CDISC also has teams working on standardizing the statistical analysis datasets to support e-Submissions and on standard nomenclature pertaining to the CDISC mission of standardizing electronic data interchange.

Here is a more detailed evaluation report as a pdf file.

Based upon the success of this initial proof-of-concept exercise, we are encouraged to move forward even more rapidly to achieve these future goals. There is a plan to hold another Clinical Data Connectathon in Europe in late October in Paris.

CDISC is continuing to explore and further develop opportunities for collaboration and model compatibility in a global sense. For example, there is now a formal relationship between CDISC and HL7 and will be a week of joint Working Group Meetings in Salt Lake City October 1-4.

CDISC also wishes to continue to expand the use of the models and to further refine them and to educate the users of these models. Initial educational activities include: a tutorial on the ODM and SDS models at the DIA EuroMeeting in Barcelona in March 2000, a poster session at the Society of Clinical Trials in May 2001, a seminar on XML/XSL by PHT and a seminar on use of the SDS models at this recent DIA Annual Meeting in July, a tutorial on the ODM model scheduled for September at the Society for Clinical Data Management Conference, and a general CDISC tutorial scheduled for the DIA CDM meeting in Paris in late October. Review comments are requested from anyone wishing to become involved in achieving the CDISC goals and objectives.