CDISC Strategy Document Version 9 (Final BOD Approved Version) 4 December 2006

Transcription

1 CDISC Strategy Document Version 9 (Final BOD Approved Version) 4 December 2006 Introduction The Clinical Data Interchange Standards Consortium (CDISC) has established standards to support the acquisition, exchange, submission and archive of data for protocol-driven research. The mission of CDISC is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare. CDISC is a global not-for-profit organization with two boards: The Board of Directors, which supervises the governing functions of the organization, i.e., functions that provide the direction, resources and structure to meet its mission, The Industry Advisory Board, comprised of one representative from each CDISC Corporate Sponsor, which provides industry input to CDISC Operations and the CDISC BOD on strategic and financial matters. The Board of Directors supports five Committees, one of which is the Strategy Committee that developed this document. The CDISC standards-related work is done primarily by volunteers, and CDISC is supported by a staff of six. A Board Committee, the Technical Advisory Committee is responsible for the CDISC work, which is organized into projects in three main focus areas. IAB members also serve on the Board Committees. In addition, there are volunteer Coordinating Committees in Europe and Japan and User Networks throughout the U.S. CDISC Coordinating Committee Leaders, Japan & Europe Industry Advisory Board CDISC Board of Directors Board Committees Executive Financial Oversight Governance Global Strategy Global Communications President Global Operations Board and IAB Support Member Services PR/Communications Business Case Website/IT; Interchanges International Operations Support New Opportunity Exploration Financial Management Program Management Alliance Management Production Standards Production Standards Updates (SDTM, SEND, define.xml, ODM, LAB, ADaM, Glossary) End-to-end Documentation Implementation Guide/Std Enhancemnt (e.g. TDM, PK, device, vaccine) Technical Advisory Committee Implementation Services Education Courses Global User Network Support Regional CDISC Coordinating Comm. (Japan, Europe) U.S. Networks Implementation Enablers ( proto-tools ) Help Desk Innovation Initiatives BRIDG Modeling SDTM-ADaM Pilot Submission in ODM XML esource Data Interchange Terminology and NIH Grants Protocol Representation Healthcare Link Industry Architecture Proposal Doc Data Collection Standards CDISC 2007 Strategy Document 1 DRAFT 18 September 19, 2006

2 Background of the CDISC 5-Year Strategic Intent The Strategy Committee remit for 2006 was as follows: 1) Outline a set of 5-10 year strategic goals for CDISC where do we want CDISC to be and what role should it play in the standards environment? 2) Identify the 1-3 year gaps in CDISC activity that would prevent us from getting to the goal. 3) Provide strategic briefs on areas of scientific opportunity for consideration during the Board's strategic planning process and recognize potential advantageous affiliations and customers. The Strategy Committee has done this 2006 work in the context of strategic planning information and outcomes from prior years. They have had teleconferences within the committee and have obtained feedback from the Board of Directors and the Industry Advisory Board. This document will serve as the basis for the 2007 Operational Plan and Budget, which will be reviewed and approved by the Board by December The Strategic plan pertains to all CDISC reaches globally. In particular, the CDISC Strategic Plan focuses on areas that highlight CDISC s unique value to the global health care industry. Tactical Implications The following paragraphs delineate and define areas for CDISC to strategically address during the next 5 years. To execute on these strategies requires that the Executive Committee (Chair, Chair-elect and President), Board of Directors and Operations staff ensure streamlined processes and rapid decision-making and follow-through. Special attention should be paid to promoting CDISC standards, ensuring smooth integration across all models with further development or enhancements, including terminology, and maintaining and/or developing strategic relationships with other organizations. The Operational Plan and CDISC Policies and Procedures must maintain the necessary nimbleness such that CDISC continues to make rapid progress with economical and efficient processes. In addition there must be a clear link between this strategic intent and the CDISC Operational and Technical Plan. While it is not the intent of this document to address the issues below and it does not do so, CDISC must also develop an Operational (tactical) plan and budget and the Board must answer the following questions: Will CDISC be a doer, facilitator, or enabler for each of these activities? How big do we want the infrastructure of CDISC to be? If it grows what would that look like? How big do we want the virtual CDISC to be? Strategic Considerations CDISC has the skills at the intersection of the triangle of domain expertise, standards expertise and business knowledge. CDISC 2007 Strategy Document 2 DRAFT 18 September 19, 2006

3 Specific to the 2007 (and beyond) Strategy for CDISC, it is felt that CDISC brings unique value to the health care industry in the following ways. Each of these is further delineated in the following paragraphs. The ability to rapidly and nimbly create standards for new endpoints and markers (e.g. imaging, genomics, PROs) EHR/HIT strategy. Connection to HL7 and other standards organizations. Standards education, communication of best practices and terminology: Safety data collection and reporting including a focus on data aggregation enhanced by the use of CDISC standards Relationship to FDA, EMEA, MHLW, and other regulatory agencies: Connections to and support from PhRMA, EPPIA and JPMA: Approach to leveraging our global, non-profit, vendor neutral, independent status Setting Industry Architecture Standards. CDISC role in the ability to nimbly create new standards around new endpoints and markers: As the science of drug discovery and development advances, new measurements of patient status and disease state will be introduced into clinical trials. These will range all the way from biomarkers and laboratory values to measure early activity of molecules to primary endpoints for clinical trials that are pivotal to approval. Recent examples of these are imaging, pharmacogenomics, and patient reported outcomes. It is important that CDISC play a role in determining the necessity and timing of the creation of standards around these new parameters. While it is recognized that developing and implementing these standards can be a complex and lengthy process, the decision on the need for and timing of the standards can happen quickly. Thus, CDISC must input views into the public debate at the time of greatest potential impact. CDISC will rely on the IAB, Strategy Committee and others to identify and raise awareness of new endpoints. The strategy for CDISC strategy is to track such developments actively and act nimbly to partner with important stakeholders to develop, influence approve, and lifecycle manage new standards. CDISC role in EHR/HIT strategy: CDISC and other industry opinion leaders envision that the future of clinical trial data capture will be integrated with the broader world of healthcare information technology and the Electronic Health Record. This integration will have a profound impact on the industry by improving the ability to recruit patients into trials; enhancing accessibility to data for disease based research; streamlining the data capture process by reducing data entry and transcription errors and associated costs/resources to resolve such discrepancies; improve pharmacovigiliance; and decreasing the number of systems required at an investigator site. An equally relevant issue is the ability of clinicians to CDISC 2007 Strategy Document 3 DRAFT 18 September 19, 2006

4 provide care that is both evidence-based and predicated on safety, knowledge of which can be derived from clinical trials databases. As part of this vision, CDISC expects to be the lead representative / spokesperson of the clinical research industry linking biomedical research and healthcare standards efforts. This will require continued involvement in worldwide healthcare IT initiatives, at the technical, Board and political levels. CDISC role in HL7 and other standards organizations: Since 2001, with the initiation of the Associate Charter Agreement, CDISC has built a strong relationship with Health Level Seven (HL7). When the US Department of Health and Human Services named HL7 as one of its primary standards developing organizations, the Food and Drug Administration joined HL7, as well, to help foster standards for clinical research data exchange. This collaboration was further strengthened when the CDISC ODM was mapped to the HL7 Reference Information Model (RIM). Finally, the most recent revision of the HL7 Charter Agreement has provided for the establishment of the board-level Outreach Committee for Clinical Research (OCCR), offering broad opportunities for joint educational programs. CDISC is the expert on Clinical Research Standards and it brings this value to HL7 as a separate but collaborative organization. CDISC continues to see the HL7 relationship as a top priority. But in order to strengthen its global reach CDISC will seek increased collaboration with ISO, CEN and other international organizations. In addition, CDISC will work with other standards (or related) organizations as appropriate. These may include those from the HITSP use cases or IHE. CDISC role in standards education, communication of best practices and terminology: CDISC has had tremendous success in developing standards in several areas due in part to the efforts of volunteer subject matter experts and contributors of work in kind. The CDISC standards are strong because of the relative simplicity of their structures and because of their intuitive design aimed at meeting industry s business needs. CDISC standards are continuously evolving within a stable process targeting compliance with future regulatory requirements. CDISC standards simplify data collection and end-toend data handling processes. CDISC also successfully developed controlled terminology and best practices across its various models, all of which can be viewed as a complete package that addresses both format and content. Therefore, CDISC has tremendous responsibility to ensure these standards, related terminology and best practices are properly maintained with continued support from the industry subject matter experts that have helped bring about success. CDISC has a key role in facilitating education on its standards, and seeking additional subject matter experts in new areas aligned with its mission and vision. It is especially important that CDISC establish an international network of experts to provide education in regions outside the US. This educational effort is important both to clinical researchers and key stakeholders in the implementation of the CDISC standards. It is recognized that there are different levels of stakeholder education. The high level policy CDISC 2007 Strategy Document 4 DRAFT 18 September 19, 2006

5 making and funding bodies require education around business case and benefits which is aligned with the Communications Committee strategy for CDISC. Education of day to day users of CDISC tools and standards necessitates a more comprehensive program and that is managed and implemented through the work of the CDISC operations staff and training programs. CDISC needs to promote standards usage to ensure smooth integration across the healthcare domain. CDISC should pay special attention to further development and/or enhance best practices and terminology. A well designed Education & Communication Plan will support and promote more advocates in the clinical research community. CDISC role in safety data collection and reporting: With increasing demands for biosurveillance, the knowledge base supporting pharmacovigilance data is growing. The pressures for improving both the reporting of adverse events and post-marketing efforts to improve drug safety are escalating. Requirements are generated at the legislative level as well as from regulatory authorities. In addition, concerns have arisen because of the trafficking of counterfeit and undocumented drug supplies. This has been manifest by federal and regional (state) legislative requirements for a certified supply chain from the manufacturer to the consumer. CDISC has an opportunity to leverage its technical experience to great advantage. The reuse or reapplication of existing CDISC standards would contribute to several key domains, including: clinical trial adverse event reporting, post-marketing pharmacovigilance, and certified supply chain documentation. Coordination with regulatory agencies is paramount, but support of other co-existing standards is essential for success. As the safety reporting environment evolves, CDISC should remain both agile and forward-looking in support of the evolving, complex ecosystem. In addition, since one of the principle benefits of the use of consistent standards is the ability to aggregate and re-use data, this feature will be highlighted to stakeholders in the execution of this part of the strategy. CDISC Relationship to FDA, EMEA, MHLW, and other regulatory agencies: It is fact that CDISC has an admirable relationship with the FDA and the FDA is the only agency that requires submission of raw data in standard format. It is also a fact that the United States is the single largest market for ethical pharmaceuticals representing better than 50% of sales for most if not all major pharmaceuticals and the FDA is the only agency that requires raw data requiring the use of standards. It is important, therefore, that CDISC must continue to cultivate their relationship with FDA on behalf of their constituents. CDISC 2007 Strategy Document 5 DRAFT 18 September 19, 2006

6 However, it is also important to understand the emerging markets in the European Union and Asia. CDISC must understand the pace of these emerging markets and balance their efforts to interact with and play a part in these regions. This may require influencing the adoption of existing standards that might be globally harmonized to speed new therapies to patients worldwide. CDISC should also consider that there are other government agencies that may have interest in standards such as the U.S. Department of Defense or Department of Veteran Affairs, the National Health Services in the UK, and other governmental agencies throughout the world. Certain of these entities play the unique role of being the payer of services, provider of services, and a government agency, thus their needs may be different than those of the regulatory authorities (e.g. more related to business-to-business standards that need to be satisfied in the greater healthcare domain). The BOD should prioritize the relationships so interactions can be used for maximum impact. CDISC connections to and support from PhRMA, EFPIA and JPMA: Routine detailed submission of data for regulatory review remains primarily a requirement for US NDAs; other agencies around the world have not adopted such requirements and do not appear to positioning themselves for creating a requirement similar to FDA. As a key stakeholder, PhRMA represents a large contingent of industry focusing on discussions with FDA regarding drug development and regulatory submissions. As a standards development organization, CDISC focuses on meeting industry and Agency submission requirements for data content and format. As a result of these facts, it is imperative that CDISC maintains a collaborative relationship with PhRMA to define, develop and implement data standards for regulatory submissions and information exchange with business partners. In particular, CDISC will be deeply involved with PhRMA s RACC, IMPACC, BDMTG and ERS committees, and will have working liaisons to those organizations. CDISC will endeavor to establish an awareness of EFPIA and JPMA activities and priorities while developing a long-term policy regarding meaningful relationships with those associations. CDISC s approach to leveraging our global, non-profit, vendor neutral, independent status: CDISC plays many vital roles in the business of standards development and implementation. One part of their role that should be leveraged greatly is its nonprofit, vendor neutral, independent status. CDISC has the ability to visibly and compellingly enter into public debates about standards and aligned issues without fear of conflict of interest. As such CDISC should and will have a credible voice. This independence along with the record of accomplishment puts the organization in a leadership role that carries with it the responsibility of driving change. Independent and neutral views and consensus-building around industry standards globally are vital to the advancement of standards development that is in the best interest of science and patients in the long run. CDISC 2007 Strategy Document 6 DRAFT 18 September 19, 2006

7 This approach requires clear vision, policy statements, and communications strategy from the Executive Committee, BOD and Operations to speak on behalf of CDISC and its constituents on relevant issues. At every meeting the BOD should review CDISC s stance on emerging issues and its strategy for communicating them to its stakeholders and the public at large. CDISC should continue to actively engage in industry trade groups and national standards/hit groups to leverage its credibility. CDISC role in setting Industry Architecture Standards The long-term benefit of any standards organization is measured through widespread adoption of its standards. A significant challenge for potential adopters of CDISC data standards, especially large organizations, is determining how best to implement those standards within each organization's overall plans for business transformation and technology management. There must be applications to support use of the data standards, and those applications must themselves fit within an overall architecture for the enterprise. One strategy for fostering standards adoption is to create a common architectural framework at the industry level, addressing not only data standards ("data interchange"), but also other fundamental aspects of what it will take to adopt: how to implement data interchange ("application integration"), how to combine software applications ("application interoperability"), and what data actually mean ("semantic interoperability"). CDISC has endorsed an effort, bringing together architects and interested business representatives from across the pharmaceutical space, to document the steps that must be taken if a shared Industry Architecture is to be achieved. The initial whitepaper deliverable will serve as a foundation for deciding on appropriate next steps for CDISC regarding Industry Architecture. Conclusion We believe this document provides necessary direction for CDISC over the next five years to maximize its unique contributions to the science of standards and capitalize on the concept that CDISC has the skills at the intersection of the triangle of domain expertise, standards expertise and business knowledge CDISC 2007 Strategy Document 7 DRAFT 18 September 19, 2006