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 May 16-17, 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

(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

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 (Provisional List)

All participants will be required to register. Registration details will be available in due course.

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

Kerstin Forsberg -- AstraZeneca

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

Randy Levin -- CDER

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