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 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 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

PLEASE NOTE THAT PARTICIPATION IN THIS MEETING IS RESTRICTED.

If you wish to be considered for participation, please send a brief statement of your expertise to Barry Smith.

Participants (First Tentative List)

Confirmed

Werner Ceusters -- NCBO, University at Buffalo

Chris Chute -- NCBO, Mayo Clinic, Rochester, MN

Lindsay Cowell -- Duke University

Norbert Graf -- ACGT, Homburg, Germany

Ted Grasela -- Cognigen Corporation, Amherst, NY

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

Samson Tu -- Stanford University

Tentative Russ Altman -- Stanford University Carol Bean -- NCRR/NIH Peter Good -- NHGRI/NIH BRIDG: ? Doug Fridsma, ? Joyce Niland CDISC: ? Becky Kush HL7: ? Lakshmi Grama caBIG: ? NIH Roadmap: ? Stuart Speedie (U. Minn) AMIA CT WG: ? Michael Kahn, Charlie Barr, AMIA KR WG: ? Columbia group on Clinical Trials Informatics Jodie Sachs, Karen Skinner, NIH FuGO WG Ricardo Pietrobon -- Duke University Randy Levin - Center for Drug Evaluation and Research Edward Tripp -- Abbott Laboratories Weida Tong (FDA NCTR, Center for Toxicoinformatics, Director) Federico Goodsaid (FDA CDER, Office of Clinical Pharmacology)