Austin, TX – 20 June 2013 – The Clinical Data Interchange Standards Consortium (CDISC) announced plans today to implement CDISC SHARE. After a comprehensive proposal and evaluation process, SOA Software’s Semantic Manager product was chosen as the SHARE technology platform by a selection committee consisting of CDISC leaders and volunteers, with substantial support from TransCelerate BioPharma Inc. (TransCelerate). “SHARE has been a long-standing strategic priority of CDISC, and is fundamental to our ability to develop and enhance CDISC standards for clinical research and especially for therapeutic areas,” said Wayne Kubick, CDISC CTO. “We at CDISC owe a great deal to TransCelerate, the CDISC Board of Directors and the many individuals who helped make this happen, and we would like to thank all the technology providers who participated in the proposal process.”
SHARE, or Shared Health And Research Electronic Library, a cornerstone of the CDISC technical roadmap, will be a global electronic repository for developing, integrating and accessing CDISC metadata standards in electronic format. SHARE is expected to dramatically improve integration among CDISC foundational standards and controlled terminologies, and support greater interoperability with healthcare. Read more >>
CDISC Shared Health And Clinical Research Electronic Library
What is SHARE?
CDISC SHARE, a cornerstone of the CDISC technical roadmap, will be a global electronic repository for developing, integrating and accessing CDISC metadata standards in electronic format. SHARE is envisioned to help users find, understand and use rich metadata and controlled terminologies relevant to clinical studies more efficiently and consistently, and to improve integration and traceability of clinical data from protocol through analysis.
Why is SHARE important?
Individual CDISC data standards were originally developed as PDF documents to address discrete areas of the clinical research process, focusing on the most commonly used data elements that appear in most clinical studies – primarily for general safety data. Over time, as the use of standards matured, it became clear that the value of CDISC standards would be increased by extending CDISC data standards to incorporate efficacy data elements and enhancing access to CDISC metadata (beyond PDF). SHARE will eventually make all CDISC metadata standards electronically accessible to computer applications in an integrated system. SHARE will also provide a collaborative standards development environment that will improve the quality, integration, reach and consistency of CDISC standards.
CDISC SHARE will guide an advanced information-based approach to standards definition and metadata development. This new process will involve consistent, unambiguous definition of clinical research concepts in the context of the BRIDG model, tracing the use of these concepts from protocol through data collection, tabulation and analysis, and binding them to specific controlled terminologies.
Use of CDISC standards through SHARE will also facilitate aggregation of data to gain new insights to inform the research process, and will improve interoperability with healthcare by aligning research concepts with external healthcare concepts. SHARE will help CDISC realize the promise of defining data standards once so data can be reused many times for multiple research purposes.
Why is SHARE so critical for Therapeutic Area standards?
With the need to develop therapeutic area standards and the subsequent launch of the CFAST initiative, it quickly became evident that the process of defining therapeutic area data standards for a multitude of disease areas would require improved tools and capabilities that could not be fully met by the previous manual data standards development process. In particular, therapeutic areas need to capture patterns of data that may not currently exist in published domains, and match specific controlled terminologies for observations relevant to specific symptoms, diagnoses, tests and assessments. Moreover, many research concepts need to be reused across therapeutic area studies, and the breadth of information covered across these research areas may involve tens of thousands of unique concepts that need to be represented (often with customization) in protocols, CRFs, tabulations and analysis files. It quickly became clear that such an ambitious undertaking was unlikely to succeed unless a robust systems environment like SHARE could be made available.
What is the History of SHARE?
The CDISC SHARE project was initiated by members of the CDISC Board of Directors, CDISC leadership and volunteers in 2007. Early work began with a stakeholder analysis to define the initial proposed scope of SHARE. In 2009, a pilot project using Mayo Clinic’s LexGRID semantic wiki tool was conducted, which verified the potential value for SHARE and highlighted the need for a more controlled metadata repository environment with strong governance. Work proceeded after that to define detailed requirements and to begin organizing CDISC content so it would be SHARE-ready: well defined, mapped to BRIDG and ISO 21090 complex data types and clearly expressing relationships between collected CDASH elements and SDTM tabulations.
In 2012, CDISC entered into a partnership with the Critical Path Institute, FDA and TransCelerate BioPharma Inc. (TCB) to establish the CFAST Initiative and the Therapeutic Area Data Standards Program, which quickly recognized the need for a metadata repository as an essential infrastructure component to support the development of numerous therapeutic area standards. With TCB’s strong support, CDISC engaged in a formal evaluation process to identify solution providers with SHARE, resulting in the selection of SOA Software’s Semantics Manager in June 2013.
What is the connection between SHARE and Controlled Terminology?
The creation and management of CDISC Controlled Terminology will continue to be maintained and extended through CDISC’s partnership with NCI’s Enterprise Vocabulary Services (EVS) as has been the case for many years. However, while EVS manages the fundamental code lists used by CDISC standards, the binding of specific value sets selected from those code lists with variables for specific use cases, such as therapeutic area standards, will eventually be managed through SHARE.
What is the relationship between SHARE and BRIDG?
The SHARE logical data model is built upon a framework based on the BRIDG Model and ISO 21090 data types. BRIDG provides the underlying reference context for consistent representation of metadata across multiple CDISC standards and therapeutic area use cases. ISO 21090 complex data types allow standards to be represented as higher level concepts or building blocks, which can then be decomposed into physical representations such as SDTM variables in datasets but also can be more easily transformed into newer data exchange formats and more easily related to healthcare concepts.
Who is involved in developing CDISC SHARE?
CDISC has assigned a senior executive to lead the SHARE project and is providing a team to support its implementation and use. But the success of SHARE, like all other CDISC standards, depends entirely on the active involvement of CDISC volunteers. Each individual company that adopts data standards must currently assess, interpret and implement, often making decisions and judgments that may lead in different directions. By working together in SHARE, those involved in the use of standards in individual companies can share their knowledge and pool their resources to support the betterment of clinical research for all.
When will CDISC SHARE be available to researchers?
We anticipate that an initial release of the CDISC SHARE system will be available for initial use by early 2014. Additional details regarding features and delivery dates will be posted as they become available.
Will there be a cost to use SHARE?
The SHARE system will be built on a licensed commercial software product, SOA Software’s Semantics Manager, in an externally hosted computing environment, and will involve significant incremental costs to CDISC for licenses, operations activities and support. CDISC is currently evaluating what are the most cost effective alternatives for making CDISC standards available through SHARE easily accessible to the CDISC community to ensure that the benefits of SHARE can be realized at a fair and reasonable cost to users.
Will the CDISC standards still be free?
Although access to the full set of SHARE features will likely involve an additional nominal cost to licensed users, CDISC will also continue to make all of its published standards free and open to the full research community (members and non-members) as has been our practice since our inception.
How will researchers be able to access and use SHARE?
SHARE is a controlled system using a commercially licensed software product, so access will be limited to named users who have been trained and qualified in the use of the system. CDISC will be publishing additional details on how to gain access as the project nears delivery.
How do I get involved with CDISC SHARE?
You can offer to take an active role in the SHARE project by completing a volunteer form and pledging time to work with the SHARE implementation and content development teams. You can contribute financial support by becoming a CDISC member or giving a donation. Finally, you can support the use of CDISC standards throughout your own organization and among your partners. The benefits of CDISC standards can only be realized when more and more organizations are using standards consistently and effectively, delivering on the promise offered by SHARE.