CDISC 2010 Strategy Document
Introduction
The Clinical Data Interchange Standards Consortium (CDISC) has established standards to
support the acquisition, exchange, submission and archiving 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.
This mission pertains to all CDISC global initiatives. In particular, the CDISC Strategic
Plan focuses on areas that highlight the unique value CDISC brings to the global health
care industry.
Five Strategic Themes
CDISC has the skills at the intersection of the “triangle” of domain expertise,
standards expertise and business knowledge.
Specific to the CDISC Strategy for 2010 and beyond, we recognize that CDISC brings
unique value to the health care industry in the following ways. Each of these themes is
further delineated in the paragraphs that follow.
Ensure the existence, harmonization, acceptance and support of standards for
medical research
Promote and provide education on the use and benefits of standards
Facilitate the integration with Electronic Health Record (EHR) / Health
Information Technology (HIT)
Use CDISC standards to support data collection and reporting with a focus on
data aggregation for the purposes of scientific investigation and comparative
effectiveness
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
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Ensure the Existence, Harmonization, Acceptance and Support of Integrated
Standards for Medical Research
As the science around discovery and development of therapies, medical research and
personalized medicine progress, new measurements of patient status and disease state
will be introduced. These will range from biomarkers and laboratory values to measure
early activity of molecules to primary endpoints for clinical studies that are pivotal to
approval. Recent examples include imaging, pharmacogenomics, and patient reported
outcomes. CDISC plays a role in determining the necessity for and timing of standards
creation around such parameters, influencing key stakeholders and other appropriate
groups. CDISC will rely on the CDISC Advisory Board (CAB), Board Strategy
Committee and others to identify and raise awareness of new standards-related
opportunities and needs.
Biomedical research standards development is the domain expertise of CDISC, whether
CDISC acts as a doer, influencer, facilitator or enabler. CDISC must track new
developments and act nimbly to partner with important stakeholders to develop,
influence, approve, harmonize, and lifecycle manage new and existing standards.
CDISC must input views into public debate at the time of greatest potential impact.
In addition to influencing decisions about emerging standards, CDISC must ensure its
standards are harmonized with one another and with other healthcare standards,
specifically the HL7 Reference Information Model (RIM). This can be accomplished by
employing the domain analysis model, specifically the BRIDG (Biomedical Research
Integrated Domain Group) model. CDISC must maintain, support and enhance, as
appropriate, the standards it develops; and, CDISC must promote acceptance of its
standards through various methods and implementation services.
This strategic theme needs to balance the old with the new. CDISC will support
standards maintenance, but CDISC will not be expected to provide maintenance a priori.
This decision should be made each time new work is considered.
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 the organization's overall plans for business transformation and
technology management. It is difficult for organizations to change their business
practices, and CDISC should support all degrees of conformance to standards. CDISC
should support standard data content (semantic interoperability) as expressed in BRIDG
and the core concepts of existing standards, standard data transport (application and data
interoperability) through work with HL7 and support of CDISC define.xml. CDISC must
explore standard architectures that support common user interfaces and work processes
(application integration). Distinguishing between data content, data transport, and data
architecture will allow businesses to use CDISC standards to the extent they support their
business objectives. CDISC should make clear these distinctions and support all degrees
of business and technology standardization.
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CDISC has had tremendous success in developing standards in several areas due in large
part to the efforts of volunteer subject matter experts (SMEs). CDISC standards are
strong because of the relative simplicity of their structures and because of their intuitive
design aimed at meeting the users’ needs. CDISC standards are continuously evolving
within a stable process targeting compliance with existing and future regulatory
requirements. CDISC standards simplify data collection and end-to-end data handling
processes. CDISC has 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 a responsibility to ensure these
standards, related terminology and best practices are properly maintained with continued
support from the industry SMEs who have helped bring about success.
Promote and Provide Education on the Use and Benefits of Standards
CDISC has a key role in facilitating education for its standards, and seeking additional
SMEs in new areas aligned with its mission. It is especially important that CDISC
establishes an international network of experts to provide education in regions outside the
US. This educational effort is important both to medical researchers and to key
stakeholders in the implementation of the CDISC standards.
We recognize that there are different levels of stakeholder education. High level policy
making and funding bodies require education around business use cases and benefits that
are aligned with the Communications Plan for CDISC. Education of technical and
application-focused users of CDISC tools and standards necessitates a more
comprehensive program. And, the U.S. FDA has sought education from CDISC for its
reviewers. CDISC Education should continue to be managed and implemented through
the work of the CDISC Operations staff and instructors and the training programs they
offer.
CDISC needs to promote standards usage to ensure smooth integration across the
healthcare domain. CDISC should be aligned with further development and/or
enhancement of best practices and terminology. A well designed Education and
Communication Plan will support and promote more advocates in the medical research
community.
CDISC needs to be proactive toward decisions that provide education about its initiatives.
It needs to ensure education but can decide to defer operational aspects of education to
other organizations. CDISC also needs to accept that part of our leadership role is to
educate the world about "Standards" and not just "CDISC standards”.
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Facilitate the Integration Clinical Research Standards and Processes with Electronic
Health Records (EHR) / Health Information Technology (HIT)
CDISC and other opinion leaders envision that the future of clinical data capture will be
integrated into the broader world of healthcare information technology and the EHR.
This integration will have a profound impact by:
Improving a sponsor’s ability to recruit patients into trials
Enhancing accessibility to data for research
Streamlining the data capture process by reducing data entry and transcription errors
while reducing associated costs/resources to resolve such discrepancies
Improving pharmacovigilance
Facilitating decision support
Decreasing the number of systems required at an investigator site
An equally relevant issue is the ability of clinicians to provide care that is evidence-
based and predicated on safety where knowledge can be derived from medical databases.
As part of this vision, CDISC expects to take a leading role on behalf of the medical
research industry by linking biomedical research and healthcare standards efforts. This
will require continued involvement by CDISC and its Board in worldwide healthcare IT
initiatives, at the technical and political levels.
CDISC has been actively engaged with the pharmaceutical industry and Integrating the
Healthcare Enterprise (IHE) and various HIT initiatives operated through the
Department of Health and Human Services (HHS) Office of the National Coordinator
(ONC) in an effort to identify how data can be harvested from the EHR for safety and
medical research. This work promises to bring about process improvements and
contribute to the aggregation of data for safety reporting, signal detection and evaluation,
including but not limited to comparative effectiveness and to streamlining biomedical
research processes.
Use CDISC Standards to Support Data Collection and Reporting with a Focus on Data
Aggregation for the Purposes of Scientific Investigation and Comparative
Effectiveness
With increasing demands for aggregated data for comparative effectiveness evaluations,
biosurveillance and drug safety surveillance, the knowledge base supporting
pharmacovigilance data is growing. There are increasing pressures to enhance the access
to information for such purposes to improve evaluations of safety and efficacy for
biopharmaceutical products and other therapies. Requirements are generated at the
legislative level as well as from regulatory authorities.
CDISC has an opportunity to leverage its experience to great advantage. The use or
application of existing CDISC standards can contribute to several key domains, including
biomedical research, adverse event reporting, post-marketing pharmacovigilance, and
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potentially certified supply chain documentation. Coordination with regulatory agencies
is paramount, but support of other co-existing standards is essential for success.
Appropriate areas of expansion for CDISC may included: a) the implementation of the
CDISC Integrating the Healthcare Enterprise (IHE) Retrieve Form for Data Capture
(RFD) integration profile to support drug safety reporting, clinical research, and
population of registries using EHRs (through the CDISC Healthcare Link Initiative), b)
the FDA Integrated Safety Data pilot and c) the harmonization of AE standards, including
National Institutes of Health (NIH) and cancer Bioinformatics Grid (caBIG) models into
BRIDG. These should be areas of focus for TAC and our EHR/HIT programs.
CDISC should remain both agile and forward-looking in support of the evolving,
complex environment. 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.
Leverage Our Global, Non-profit, Vendor Neutral, Independent Status to Forge
Productive Collaborations with Other Standards Development Organizations (SDOs)
and Key Stakeholder Communities including Regulators and Health Agencies
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 non-
profit, 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
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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), Comité Européen 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
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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.
Conclusion
We believe this document provides necessary direction for CDISC over the next five
years by maximizing its unique value to the global health care community and
capitalizing on the concepts of borderless innovation and strength through
collaboration.
This document will be a “living document” that will be reviewed regularly and changed
as appropriate to the evolving environment.
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