CDISC JOURNAL 2011

A number of CDISC stakeholders contributed articles to the CDISC eJournal 2011, which is distributed via the CDISC website and in CD format only. CDISC is the leading standards developing organization (SDO) focusing on data standards for medical research. These eJournal articles represent case studies and survey information reflecting the implementation of CDISC standards and their value and adoption towards our CDISC vision to inform patient care and safety through higher quality medical research. We are now collecting articles for the CDISC eJournal 2012. Please contact Diana Harakeh if you are interested in contributing.

The CDISC Vision is to Inform Patient Care & Safety Through Higher Quality Medical Research

Generating a caBIG Patient Study Calendar from a Study Design in ODM with Study Design Model Extension - Article by Jozef Aerts

The Study Design Model (SDM) extension for ODM is currently being developed by a working group consisting of members of the XML Technologies Team and of the Protocol Representation Group (PRG). The major features of this extension are being presented. The SDM-XML extension has been used to generate an example study design instance which has then been transformed to a caBIG Patient Study Calendar (PSC). Follow the link for the full article.

Healthcare Link and eSource - Article by Landen Bain

Clinical research data follow a life cycle that begins with data capture and ends with the submittal of a data set to the regulatory agency and/or publication in a report or journal. CDISC began its work at the tail end of this cycle by first specifying how data should be submitted for review, then moved through progressively earlier stages of the data life cycle with standards for data acquisition, data management and data analysis. The earliest step in the data progression, the electronic capture of research data directly from healthcare information (at the source), remained an open gap in the CDISC chain of specifications, even though eSource was a key aspect of the driving vision of CDISC’s founders. The CDISC Board launched the Healthcare Link initiative several years ago to close this last unspecified gap in the clinical research data life cycle. Please follow the link.

Genzyme’s GetSMART Program: Implementing Standards End-to-End - Article by Sue Dubman, Brooke Hinkson, Dana Soloff, David Fritsche and PK Tandon

At the end of 2008 Genzyme initiated GetSMART, a Strategic, Measurable, Achievable, Realistic, and Time-based program, to implement global clinical information standards. The GetSMART vision is to consistently define, use, and reuse clinical information across the development lifecycle through the use of standards in order to facilitate the exchange of information (data and content), streamline our business processes and prepare to comply with existing regulations, current regulatory requests and likely future mandates. Follow the link.

The BRIDG Model and a “Model” Implementation: The Clinical Trial Registration and Results HL7 Message - Article by Julie Evans and Abdul-Malik Shakir

The Biomedical Research Integrated Domain Group (BRIDG) Model is a Domain Analysis Model (DAM) representing protocol-driven research. A DAM is a conceptual, abstract representation of an area of interest, which can be used as input to the technical design of software, data interchange specifications, and databases. A DAM should be understandable and usable by domain experts and technology developers alike. Having been in existence for over five years, BRIDG is alive and well: semantic content is being added and an increasing number of projects are using BRIDG for the basis of their information requirements. One such project is the HL7 V3 Clinical Trials Registration and Results message. This article gives a brief summary of BRIDG followed by a description of the CTRR project. Follow the link.

CDISC: Adoption Trends, Benefits and Addressing Barriers - Article by William Friggle, Feng Li, Shannon Labout, Rebecca Kush

Results of an online survey of CDISC stakeholders indicates that the CDISC standards continue to gain traction among clinical researchers. Among the 641 respondents who answered the demographics section, the Study Data Tabulation Model (SDTM) is the most widely used and the Clinical Data Acquisition Standards Harmonization (CDASH) standard for case report forms has the most users piloting as of the end of the survey period, March 2010.. CDISC Healthcare Link Initiative was largely unknown by the respondent community. Clinical Research Organizations (CROs) are consistently adopting the standards more readily than are biopharmaceutical companies. The greatest benefits from the use of the CDISC standards were cited as: a) to improve data exchange; b) to improve study efficiency and c) to improve data quality. Perceived barriers include: a) a lack of understanding of the CDISC standards; b) cost of implementation and c) that the existing domains do not cover a sufficient amount of the data. Of the 475 respondents to a question about eSubmissions, 166 replied that their organizations have submitted at least one. When survey participants were asked how CDISC can assist in improving the adoption of the CDISC standards, the top responses were: a) to work with regulators to provide greater clarity; b) provide more case studies; and c) produce more therapeutic/efficacy standards. Significant progress has been made in terms of addressing these areas since the survey was conducted. This progress is shared in depth in the Discussion section. Follow the link.

The Value of CDISC: Results of a Brief Survey - Article by Diana Harakeh, Saad Yousef, Rebecca Kush

The word ‘value’ in English is defined as relative worth, merit, or importance. John Perry Barlow, lyricist of the band ‘The Grateful Dead’ wrote “…here’s the thing: if I give my song away to 20 people and they give it to 20 people, pretty soon they know me, and my value as a creator is dramatically enhanced”. In another interview with Wired Magazine he stated: “The best way to raise demand for your product is to give it away”. (Joshua Green, March 2010, The Atlantic, “Management Secret of the Grateful Dead”). Oddly enough, the Dead’s influence on the business world may turn out to be a significant part of its legacy. The Dead were masters of creating and delivering superior customer value. One idea was to focus intensely on its most loyal fans. This premise of creating value by giving products away is analogous to the practice of the Clinical Data Interchange Standards Consortium (CDISC). While other standards developing organizations (SDOs) in the related area of healthcare still require fees or membership to access their standards, CDISC has held strongly with the belief that these should remain open and free to encourage adoption and participation- --and to create value. Follow the link.

Data Model - the trials and tribulations of implementing BRIDG in an Information Technology Environment - Article by Terry Hardin and Isabelle deZegher

Over the past several years there has been much discussion regarding BRIDG (Biomedical Research Integrated Domain Group) within CDISC and HL7 as a Domain Analysis Model (DAM). These discussions center on ways that BRIDG can be used as semantic “glue” across evolving and established standards. However, there has been little work in moving BRIDG from “glue” to a common data model (CDM) that could be implemented within an IT infrastructure. In this new role BRIDG 3.0.1 would be used to move from a conceptual model with abstract data types to an implementable data model with simple data types that, in combination with business process rules, would allow for flexible system integration. Follow the link.

Regulatory Submissions for Medical Devices and Diagnostics: The Basics - Article by Carey G. Smoak

Medical devices and diagnostics are an important part of the healthcare industry. The number of device approvals by the FDA has increased by 52% in the past decade. Devices are different than pharmaceutical products in terms of the FDA approval process, and the use of CDISC standards. In May 2006 an SDTM Device sub-team was formed. The team was expanded in February 2009 to include CDASH. The Device sub-team is working towards to the goal of modifying existing domains (as needed) and developing new domains, which will be incorporated into CDASH and SDTM standards. Follow the link.

Using CDISC ODM to Migrate Data - Article by Alan Yeomans

The migration of data from a legacy system to a new EDC system poses both technical and regulatory challenges. System architectures differ widely, database structures are not compatible and it is rare that a simple copy-paste type of solution can be applied. This paper describes the choice of CDISC ODM as a mechanism to migrate data from a legacy system that did not support CDISC standards, and the work entailed. Conversion, cleaning, archiving, migration, export to a legacy data analysis system and validation of the data were all aspects that were included in the migration project. The migration took approximately 6 months to prepare, and 3 days to perform. Follow the link.