5: Collaboration

Leverage our global, nonprofit, vendor neutral, independent status to forge productive collaborations with other Standards Development Organizations (SDOs) and key stakeholder communities including regulators and health agencies

Other Information:

CDISC plays many vital roles in the business of standards development, implementation, and maintenance. CDISC has the ability to visibly and compellingly enter into public debates about standards issues without fear of conflict of interest because of its nonprofit, vendor neutral, independent status. This status, along with subject matter expertise contributed by its membership, contributes to the credible voice it enjoys in the medical research community. CDISC's independence and its record of accomplishments elevate the organization to a leadership role that carries the responsibility of driving change. Independent, neutral views and consensus-building are vital to the advancement of global standards that are in the best interest of science and patients in the long run. This approach requires clear vision, policy statements, and a communications strategy from the Executive Committee, Board of Directors and Operations when speaking on behalf of CDISC and its constituents on relevant issues. At every meeting, the Board should review CDISC's position on emerging relevant issues and its strategy for communicating to its membership, 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. Relationship to the Food and Drug Administration (FDA), European Medicines Agency (EMEA), and Japan's Ministry of Health Labor and Welfare (MHLW) and Pharmaceutical and Medical Devices Agency (PMDA) other regulatory and health agencies -- CDISC has a long-standing and admirable relationship with the FDA. Because the FDA is the only agency that requires submission of raw data in standard format, the relationship is unique. Moreover, the United States is the single largest market for ethical pharmaceuticals, representing better than 50% of pharmaceutical sales. It is important, therefore, that CDISC continue to cultivate its relationship with the FDA on behalf of its constituents. It is also important to understand the pace of emerging markets in the European Union and Asia. CDISC has been given an advisory role to EMEA for its eSource Data Interchange (eSDI) work that is being referenced in EMEA documents. Additionally, the Japanese MHLW has now included CDISC as a part of its 5-year plan and CDISC has a project planned with PMDA. CDISC has also met with the State FDA (SFDA) in China and should assess how best to develop a relationship with that agency. CDISC must balance its efforts to interact with these organizations and evolve its role in these regions. This may require influencing the adoption of existing standards to speed new therapies to patients worldwide. There are other government agencies that may have interest in standards for healthcare and biomedical research, such as the U.S. Department of Defense (DoD) or Department of Veteran Affairs (VA), the National Health Services (NHS) in the UK, and other governmental agencies throughout the world. Certain of these entities play the role of being the payer of services, provider of services, and a government agency. As a result, their needs may be different than those of regulatory authorities (e.g. more related to business-to-business standards); these may need to be satisfied in the greater healthcare domain. Collaborations with other Standards Development Organizations (SDOs) and other key stakeholder organizations -- Since 2001, with the initiation of an Associate Charter Agreement (Memorandum of Understanding or MOU), CDISC has built a formal and strong relationship with Health Level Seven (HL7). This collaboration was further strengthened through CDISC's initiation of the BRIDG model, which has now been adopted by the HL7 Regulated Clinical Research Information Management (RCRIM) Workgroup as its domain analysis model and serves to link the biomedical research standards with the healthcare standards from HL7. CDISC also has a position on the HL7 Board of Directors. CDISC is the expert on Biomedical Research Standards and thus brings value to HL7 and other SDOs as a separate but collaborative organization. CDISC continues to see the HL7 relationship as a top priority. However, CDISC will also seek to strengthen its global reach through direct collaboration with the International Organization for Standardization (ISO) (leveraging its new Liaison A status), Comite Europeen de Normalisation (CEN) and other international organizations, particularly through its role as a member of the Joint Initiative Council (JIC). CDISC will work with other key stakeholder organizations as appropriate, including but not limited to the Pharmaceutical Research and Manufacturers of America (PhRMA), the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Japan Pharmaceutical Manufacturing Association (JPMA). CDISC is also now a charter member of the US Standards Developing Charter Organization (SCO). Routine, detailed submission of data for regulatory review remains primarily a requirement for US New Drug Applications (NDAs). Other agencies around the world have not adopted such requirements. 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 realities, it is imperative that CDISC maintains a collaborative relationship with PhRMA to define, develop and implement data standards for regulatory submissions and for information exchange with business partners. CDISC will have working liaisons as appropriate to PhRMA initiatives. CDISC will continue its relationship to other areas of PhRMA through its work on CDASH data collection standards and other relevant CDISC projects. CDISC will continue to build an awareness of EFPIA activities and priorities, while developing a long-term policy regarding meaningful relationships with this association. CDISC will continue to strengthen its relationship with JPMA since their data management group has now explicitly endorsed CDISC standards and has initiated relationship with CDISC and the CDISC Japan CDISC Coordinating Committee (J3C). Given the growth and influence of CDISC, the Board and a Collaborations team have begun to set a more structured approach for collaborations since 2008. This should be reviewed annually to manage the resources needed to maintain these relationships.

Stakeholder(s):

• Standards Development Organizations

Objective(s):

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