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Some significant examples of collaborations and direct deployment use of EVS resources and services are briefly outlined in this section and those that follow for covering NCI, caBIG, and in later sections covering NIH, other Federal government and standards organizations, and other partnerships. The following profiles are included herecaBIG® and other organizations in the cancer research and biomedical community. This NCI section includes the following profiles:
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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 the detailed description below).
Common Terminology Criteria for Adverse Events (CTCAE)
CTCAE, created by CTEP in 1983, 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 plays a major role 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, caBIG®, the FDA, 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 .
Cancer Diagnosis Program (CDP) - Diagnostics Evaluation Branch
- EVS is supporting gene nomenclature used in a new CDP Biomarker project, including updating HUGO in the EVS servers so it is accessible to CDP curators.
- In an extension to this project, EVS will be creating gene and protein sequence variations in the NCIt, according to HGVS guidelines, for genes/proteins of therapeutic interest as requested by CDP. The initial request is 150 genes (in progress), with about 180 protein variants, 300 gene variants, 300 fusion genes, and 300 fusion proteins.
- This work is to support creation of an application to retrieve content from the NIH Clinical Trial Database into the NCI Clinical Trials Reporting Program (CTRP), and is being done jointly with DCTD, NCI/OCE, NCI/CCR and NIH/NLM.
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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
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.
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NCI
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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.
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