Workshop on Clinical Trial Ontology
The National Center for Biomedical Ontology will host a two-day workshop focused on the Ontology of Clinical Trials. The workshop will take place in May 2007 at a venue to be determined.
Aim of the workshop
The aim of the workshop is to foster the creation of a reference ontology (high-quality controlled structured vocabulary) for clinical trial annotation. The ontology should comprehend terms like: cohort, randomization, placebo, response, efficacy, control, protocol, null hypothesis, control, confidence interval, finding, biomarker, etc., including also major relevant statistical terms and terms drawn from the CDISC glossary.The ontology will organize these terms in a structured way, providing definitions and logical relations designed to advance reasoning with the data annotated in its terms.
The proposed CTO should:
(1) fully and faithfully capture the types of entities and relationships involved in clinical trials of any experimental design
(2) comprehend all the terms needed for the task of meta-analysis of clinical trials
(3) support trial bank interoperation
The purpose of the meeting is to bring together representatives of the major groups involved in clinical trial informatics, design, execution, analysis and standardization in order to approve an initial draft of the CTO and create a strategy for its further development and testing.
Further topics to be addressed include:
i. The relation between CTO and data-model-oriented initiatives (HL7, CDISC, BRIDG, caBIG).
ii. The relation between CTO and a drug (trial) ontology
iii. The relation between CTO and an epidemiology study ontology
iv. The proper treatment of types (surgical intervention, tumor, human being) and instances (Jane's oophorectomy, John's tumor, Fritz) in ontologies and related artifacts.
v. The relation between CTO, Trialbank, and OBD.
PLEASE NOTE THAT PARTICIPATION IN THIS MEETING IS RESTRICTED.
If you wish to be considered for participation, please send a brief statement to Barry Smith.
Participants (Initial List)
Carol Bean -- NIH/NCRR
Werner Ceusters -- NCBO, University at Buffalo
Chris Chute -- NCBO, Mayo Clinic, Rochester, MN
Lindsay Cowell -- Duke University
Liju Fan -- Ontology Workshop, LLC
Jennifer Fostel -- NIH/NIEHS
Gilberto Fragoso -- NIH/NCI
Louis J. Goldberg -- University at Buffalo
Federico Goodsaid -- (FDA CDER, Office of Clinical Pharmacology)
Norbert Graf -- ACGT, Homburg, Germany
Ted Grasela -- Cognigen Corporation, Amherst, NY
Tina Hernandez-Boussard -- PharmGKB, Stanford University
Suzanna Lewis -- NCBO, Berkeley
Chris Mungall -- Howard Hughes Institute
Mark Musen -- NCBO, Stanford University
Fabian Neuhaus -– NCBO, University at Buffalo
Philippe Rocca-Serra -- EBI, Hinxton, Cambridge
Nigam Shah -– NCBO, Stanford Medical Informatics
Susanna Sansone -- EBI, Hinxton, Cambridge
Ida Sim -- NCBO, University of California at San Francisco Medical Center
Barry Smith -– NCBO, University at Buffalo
Holger Stenzhorn -- IFOMIS, Saarbrücken
Weida Tong -- Center for Toxicoinformatics, FDA NCTR
Samson Tu -- Stanford University
Gabriele Weiler -- Fraunhofer Institute, Sankt Ingbert, Germany