Workshop on Clinical Trial Ontology

General Information

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 March 2007; 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 provide a definitions for terms like: cohort, randomization, placebo, response, efficacy, control, protocol, null hypothesis, control, confidence intervals, etc., including also major relevant statistical 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

(4) form an integral part of a more comprehensive investigation ontology, including also the Functional Genomics Investigation Ontology, which should form part of the OBO Foundry.

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.

Participation

Requests for participation are welcome. Please send a brief statement of your expertise to Barry Smith.

Participants (First Tentative List)

Russ Altman -- Stanford University

Werner Ceusters -- NCBO, University at Buffalo

Lindsay Cowell -- Duke University

Norbert Graf -- ACGT, Homburg, Germany

Ted Grasela -- Cognigen Corporation, Amherst, NY

Mark Musen -- NCBO, Stanford University

Fabian Neuhaus -– NCBO, University at Buffalo

Ricardo Pietrobon -- Duke University

Nigam Shah -– NCBO, Stanford Medical Informatics

Susanna Sansone -- EBI, Hinxton, Cambridge

Ida Sim -- NCBO, University of San Francisco Medical Center

Barry Smith -– NCBO, University at Buffalo

Still more tentative: BRIDG: Doug Fridsma, Joyce Niland (maybe) CDISC: Becky Kush HL7: Lakshmi Grama caBIG: not sure exactly who would be right NIH Roadmap: Stuart Speedie (U. Minn) AMIA CT WG: Michael Kahn, Charlie Barr, AMIA KR WG: not sure who Columbia group on Clinical Trials Informatics