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Page History
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- Harmonization and use of NCIt drug and molecular target information in CTEP systems.
- Harmonization and integration of CTEP disease classification with NCIt, PDQ and MedDRA in NCIm.
- Joint development, together with other partners, of the redesigned Common Terminology Criteria for Adverse Events (CTCAE) v.4, which has been widely adopted since its release in 2010 . (See see the detailed description in the Example Case Studies section below).)
The Cancer Diagnosis Program (CDP) - Diagnostics Evaluation Branch
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- NCIt drug information used in the PDQ clinical trials database.
- NCI Drug Dictionary: NCI Thesaurus provides original definitions for the drugs presented in this tool, with about 40,000 visitors monthly (see section 3EVS Server statistics above).
- NCIt terminology for cancers and related conditions, procedures, and chemotherapy regimens, involving many years of development and harmonization between PDQ and NCIt terminology.
- NCI Glossary includes lay definitions for key cancer terms, and is incorporated into NCI Thesaurus.
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DCCPS collaboration includes several terminology projects related to cancer classification, drugs, chemotherapy regimens, and statistics. DCCPS is currently launching a new initiative on standardized terminology for population health data collection.
NCI Division of Extramural Activities (DEA)
Portfolio Management Application (PMA-DCCPS): EVS has worked with DCCPS for a number of years to integrate PMA-DCCPS grant coding terminology with other EVS resources. NCIt now includes more than 1,500 concepts for PMA grant coding. PMA terms are also inserted and appear in the NCI Metathesaurus as a separate terminology.
NCI Division of Extramural Activities (DEA)
DEA is supported by EVS, which helps collect, develop and map grant-related terminology, including representing NCI DEA is supported by EVS, which helps collect, develop and map grant-related terminology, including representing NCI in the NIH Research, Condition and Disease Categorization (RCDC) effort.
Other NCI
NCI Supported Cooperative Human Tissue Bank (CHTB): EVS has supported terminology creation and editing for this network of research institutions, which host NCI funded tissue facilities and services providing remnant human tissue and fluids from routine procedures to investigators (NCI, Vanderbilt, U. Penn, UAB School of Medicine, Nationwide Children's Hospital, Ohio State, University of Virginia) There is active use by 14 academic and research organizations and eight (8) commercial organizations. EVS staff assisted with matching up terminology used by these groups to NCIt terminology, creating new NCIt concepts and definitions as needed.
Cancer Central Clinical Database (C3D): EVS provides support for C3D, largely through providing the new and updated terminology and definitions for case report forms. C3D currently supports electronic submission of clinical trials data to the NCI Clinical Data System (CDS) and the Clinical Trials Monitoring Service (CTMS/Theradex).
OPEN (Oncology Patient Enrollment Network): This web-based registration system for patient enrollments onto NCI-sponsored Cooperative Group clinical trials is a highly active project; most terminology supplied for this is standard demographic terminology.
PMA-DCCPS Grant Coding: EVS has worked with DCCPS for a number of years to include in NCIt more than 1,500 concepts for grant coding for DCCPS's Portfolio Management Application. PMA terms are also inserted and appear in the NCI Metathesaurus as a separate terminology.
Common Terminology Criteria for Adverse Events (CTCAE): CTCAE is used throughout the entire oncology community as the standard classification and severity grading scale for adverse events in cancer therapy clinical trials and other oncology settings. It is also used in a number of non-oncology trials and settings.
Version 4, released in May 2009, is a major update based on extensive international participation by stakeholders and experts. It is harmonized with MedDRA at the Adverse Event (AE) level, includes revised AE terms and severity indicators to reflect clinical effects identified with current oncology interventions, and is a caBIG® vocabulary standard. This version is used by more than 50 academic and research organizations, as well as many commercial and non-profit organizations. Five different Apple applications utilize the NCI Thesaurus version of the CTCAE data, and cite NCIt as the source.
Common Terminology Criteria for Adverse Events (CTCAE): CTCAE is used throughout the entire oncology community as the standard classification and severity grading scale for adverse events in cancer therapy clinical trials and other oncology settings. It is also used in a number of non-oncology trials and settings.
Version 4, released in May 2009, is a major update based on extensive international participation by stakeholders and experts. It is harmonized with MedDRA at the Adverse Event (AE) level, includes revised AE terms and severity indicators to reflect clinical effects identified with current oncology interventions, and is a caBIG® vocabulary standard. This version is used by more than 50 academic and research organizations, as well as many commercial and non-profit organizations. Five different Apple applications utilize the NCI Thesaurus version of the CTCAE data, and cite NCIt as the source.
CTCAE is designed to integrate into information networks for safety data exchange, and is expected to have a significant impact in data management for AE data collection, analysis, and patient outcomes associated with cancer research and care. EVS played a central role in designing and managing this effort, working closely with CTEP, DCP, VCDE, the Vocabulary Knowledge Center, and many participants from the broader community. The revision was developed and deployed using various EVS tools including the BiomedGT Wiki, Protégé editing tools, LexEVS terminology server, NCI Term Browser, and the EVS ftp site http://evs.nci.nih.gov/ftp1/CTCAE/About.html .
Cooperative Human Tissue Bank (CHTB): EVS has supported terminology creation and editing for this network of research institutions, established by the NCI Cancer Diagnosis Program in 1987 and now including six divisions located at Vanderbilt, U. Penn, UAB School of Medicine, Nationwide Children's Hospital, Ohio State, University of Virginia. CHTB hosts NCI funded tissue facilities and services providing remnant human tissue and fluids from routine procedures to investigators. There is active use by 14 academic and research organizations and eight (8) commercial organizations. EVS staff assisted with matching up terminology used by these groups to NCIt terminology, creating new NCIt concepts and definitions as needed.
Cancer Central Clinical Database (C3D): EVS provides support for C3D, largely through providing the new and updated terminology and definitions for case report forms. C3D currently supports electronic submission of clinical trials data to the NCI Clinical Data System (CDS) and the Clinical Trials Monitoring Service (CTMS/Theradex).
OPEN (Oncology Patient Enrollment Network): This web-based registration system for patient enrollments onto NCI-sponsored Cooperative Group clinical trials is a highly active project; most terminology supplied for this is standard demographic terminologyCTCAE is designed to integrate into information networks for safety data exchange, and is expected to have a significant impact in data management for AE data collection, analysis, and patient outcomes associated with cancer research and care. EVS played a central role in designing and managing this effort, working closely with CTEP, DCP, VCDE, the Vocabulary Knowledge Center, and many participants from the broader community. The revision was developed and deployed using various EVS tools including the BiomedGT Wiki, Protégé editing tools, LexEVS terminology server, NCI Term Browser, and the EVS ftp site .
Users: NIH
National Library of Medicine (NLM)
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NCI is also a contributor to the UMLS, for example, providing monthly builds of NCIt for inclusion in UMLS. (UMLS only publishes twice yearly; they pull whichever build is most current at the time they begin processing.) EVS also worked with NLM and other federal partners to develop the Federal Medication Terminologies framework for harmonized medication coding (see below). EVS staff provided startup start-up phrase dictionaries and search criteria for the PubMed Cancer Subset, and jointly maintains this content with NLM on an ongoing basis.
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The Cancer Genome Atlas (TCGA) is a joint effort between NCI and NHGRI, developing a database of the changes that occur in the genome, associated with a specific cancer type. TCGA creates a national network of research and technology teams, and provides a mechanism for pooling results; data are publically publicly available. 25 Studies are associated with this data, and data are being actively submitted or used by 16 academic and research organizations, 27 commercial organizations, and 17 non-profit organizations. EVS supports terminology for annotating the CDEs for tagging information and samples, mainly cell and specimen type, with information about tumor size, anatomic location, sample preparation, and patient demographics.
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Since 2009, NICHD and EVS have jointly developed terminology in NCIt for pediatric terminology, including standardizing data for newborn screening forms, through the Pediatric Terminology Harmonization Initiative, developed to assist Pediatric clinical researchers. This is associated with 848 NICHD Clinical Trials, and is being used by 52 different academic and research organizations.
National Institute of Dental and Craniofacial Research (NIDCR)
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Since 2008, NIDCR and EVS have jointly developed terminology in NCIt for dental treatments and medical procedures.
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(For more information, visit the NCI website http://www.cancer.gov/cancertopics/cancerlibrary/terminologyresources/FDA.)
Clinical Data Interchange Standards Consortium (CDISC)
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(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.
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(For more information, visit the NCI website http://www.cancer.gov/cancertopics/cancerlibrary/terminologyresources/ncpdp.)
Federal Medication Terminologies (FMT)
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.)
Veterans Health Administration (VHA)
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