NCI EVS has extensive partnerships with government and standards organizations beyond NIH to develop terminology standards, content, technology, and operational support. Such partnerships are designed to directly support NCI's cancer research mission, improving regulatory, federal and community practices in ways that contribute to the conduct and sharing of cancer research while also having a positive impact on the wider biomedical community. The following collaborations are included below:
- U.S. Food and Drug Administration (FDA)
- Clinical Data Interchange Standards Consortium (CDISC)
- National Council of Prescription Drug Providers (NCPDP)
- Federal Medication Terminologies (FMT)
- Veterans Health Administration (VHA)
- Health Level 7 (HL7)
- World Health Organization (WHO)
- The Taiwan Cancer Registry
FDA has worked with EVS since 2001, with formal Memoranda of Understanding starting in 2004, to develop and harmonize terminology content, standards and systems in areas of mutual interest such as drugs, devices, patient safety, and clinical trials. FDA has chosen EVS and NCIt for developing and publishing many important terminology sets; some 15,000 FDA terms in over 20 defined subsets are now maintained in NCIt and required for regulatory reporting and other purposes. These include:
- Structured Product Labeling (SPL): Standard terminology for Drug Establishment Registration (Regulated Product Submission), Drug Listing and the Content of Labels. 16 NCIt subsets used for submission of proposed labeling by all manufacturers using electronic formats. There are 9,466 establishments from over 100 countries that use the SPL terminology in order to comply with federal regulations to list their products. There are approximately 40,000 subscribers to the FDA's SPL listserv, and this is one of the primary mechanisms to inform users of changes to the SPL terminology that is maintained by NCI. FDA does not track the number of hits against http://www.fda.gov/ForIndustry/DataStandards/default.htm and its sub pages, but they suspect that the number of hits is very high; when firms do not select the correct NCIt code, their submitted SPL file will not pass validation.
- CDRH Device Event Problem Codes: NCIt subsets used for the reporting of medical device problems to FDA. CDRH is responsible for ensuring the safety and effectiveness of medical devices and eliminating unnecessary human exposure to man-made radiation from medical, occupational and consumer products. Approximately 200 organizations from some 3,000 different reporting locations report to the CDRH using NCI Thesaurus terminology. CDRH receives approximately 35,000 submissions per month that are based on NCI Thesaurus terminology.
- Individual Case Safety Report (ICSR): NCIt subsets used for adverse event reporting. Proposed regulations for electronic submissions will create similar levels of use for these subsets.
- eCTD (electronic Common Technical Documents): Standard terminology for regulatory forms required by the Center for Drug Evaluation and Research (CDER).
- Drug Submissions: Beginning June 1, 2009, FDA no longer accepts paper submissions for drug establishment registration and listing unless a waiver is granted. Moving from a paper-based format to an electronic system will improve the timeliness and accuracy of the submissions. This is not possible without the terminology provided by NCI Thesaurus. Of 22,246 New Drug related Submissions from October 2009 - September 2010, (63%) were in electronic format submissions that required terminology from NCI Thesaurus.
- Stability: NCIt provides terminology for FDA and HL7 Stability Data Standards, including human pharmaceuticals, animal drugs and medical devices that are in regulatory submissions, amendments, supplements and annual reports.
(For more information, visit the NCI website http://www.cancer.gov/cancertopics/cancerlibrary/terminologyresources/FDA.)
All CDISC controlled terminology – more than 9,800 terms – is maintained and published as NCIt subsets, as part of a partnership started in 2002 to develop and support global data standards for medical research. This includes four main terminology efforts:
- Study Data Tabulation Model (SDTM): An approved standard for FDA submissions, SDTM has been downloaded more than 14,000 times in over 60 countries, primarily for institutional use. More than 270 commercial organizations use SDTM, as do numerous academic, non-profit and research organizations.
- Clinical Data Acquisition Standards Harmonization (CDASH) is developing clinical research study content standards in collaboration with sixteen partner organizations including NCI.
- Analysis Data Model (ADaM) supports efficient generation, replication, review and submission of analysis results from clinical trial data.
- Standard for Exchange of Non-Clinical Data (SEND) extends Study Data Tabulation Model (SDTM) for non-clinical studies and now includes some 1,900 additional terms.
(For more information, visit the NCI website http://www.cancer.gov/cancertopics/cancerlibrary/terminologyresources/CDISC.)
The CDISC Shared Health and Research Electronic Library (SHARE) project is also building a collaborative authoring platform for harmonizing data elements from multiple organizations, using LexWiki for its initial prototype. CDISC has created a data element curation process, including terminology linking, using the LexWiki and LexGrid technologies; this process provides a collaborative framework and platform for representation and harmonization of clinical study data elements. CDISC will use open tools created by NCI as the basis for developing SHARE.
NCPDP is a not-for-profit, ANSI-accredited, Standards Development Organization with over 1,600 members representing virtually every sector of the pharmacy services industry. NCPDP creates and promotes the transfer of data related to medications, supplies, and services within the healthcare system through the development of standards and industry guidance. In 2009, NCPDP decided to partner with EVS to use NCIt subsets to support two of those standards, employed by some 200 vendors serving approximately 15,000 pharmacies nationwide:
- NCPDP SCRIPT Standard supports messages for new prescriptions, prescription changes, refill requests, prescription fill status notification, prescription cancellation, medication history, and transactions for long term care environments. Many large providers such as First DataBank and Surescripts, the nation's largest e-prescriber, use this standard. Surescripts alone connects thousands of pharmacies across the US, and is connected to the largest network of payers and Medicaid Fee for Service payers nationwide.
- NCPDP Telecommunication Standard supports the electronic communication of claims and other transactions between pharmacy providers, insurance carriers, third party administrators, and other responsible parties.
(For more information, visit the NCI website http://www.cancer.gov/cancertopics/cancerlibrary/terminologyresources/ncpdp.)
Work started in 2002 as an interagency collaboration between NCI EVS, FDA, VHA, and NLM – joined later by AHRQ, CMS, DoD, and EPA – to improve the exchange and public availability of medication information with coordinated development of terminology standards. The initial FMT terminology set has been endorsed by U.S. Federal standards efforts including the National Committee on Vital and Health Statistics (NCVHS), Consolidated Health Informatics (CHI), the Healthcare Information Technology Standards Panel (HITSP), and the Office of the National Coordinator for Health Information Technology (ONC) within the Department of Health and Human Services (HHS). (For more information, visit the NCI website http://www.cancer.gov/cancertopics/cancerlibrary/terminologyresources/fmt.)
VHA has worked closely with EVS since 2002. Under an ongoing Memorandum of Understanding, VHA works with EVS on collaborative terminology policy and products, including content collaboration and publication of the VA's National Drug File Reference Terminology (NDF-RT), used by both agencies as a drug information reference resource.
The VHA also performed a thorough comparison of the functional capabilities of LexEVS to those of other terminology servers. The VA provided the results to the VKC, which transformed the matrix into a document that can be used by potential adopters of LexEVS as they evaluate the capabilities of the system. This is an example of a valuable contribution from the community that is not code-based; in an open source model, contributions of documentation can be as important as contributions of code.
EVS supports terminology content for the Regulated Clinical Research Information Management (RCRIM) committee of HL7, and for other committees as appropriate including Patient Safety, Pharmacy, Clinical Genomics, and the Clinical Interoperability Council.
WHO requested in June, 2009, a Classification Markup Language (ClaML) LexEVS data processing program that could be used to render ICD-10 in preparation for, and as the foundation of, ICD-11. This is an example of an international standards organization using NCI's open source tooling to support the development of a new version of a major international terminology standard.
WHO work on ICD-11 is also using NCI Thesaurus as an important source of cancer terminology and definitions.
MedDRA (Medical Dictionary for Regulatory Activities) is an ICH standard for regulatory reporting. EVS contributes to updates of the cancer domain for this widely employed international terminology. The NCI Thesaurus is used as the basis to update MedDRA neoplastic terminology. MedDRA is translated into 11 languages, with approximately 3,000 institutional subscribers from 60 countries.
The Taiwan Cancer Registry, a population-based cancer registry founded in 1979, uses NCI Thesaurus terminology. Hospitals with greater than 50-bed capacity that provide outpatient and hospitalized cancer care are recruited to participate in reporting all newly diagnosed malignant neoplasms to this registry.