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 on May 16-17, 2007 at the NIH Campus in Bethesda, MD. We are grateful to the National Heart, Lung and Blood Institute for generous support.
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, confidence interval, finding, biomarker, primary outcome, secondary outcome, intervention group, experimental design, etc., including also major relevant statistical terms and terms drawn from resources such as 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 Ontology for Biomedical Investigations OBI, which forms part of the OBO Foundry, and drawing on the Epoch ontology used by the Immune Tolerance Network.
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.
Agenda [Draft]
Clinical Trial Ontology
Venue: NIH Campus, Bethesda, MD
May 16 Natcher Balcony A
8.00am Continental Breakfast
9.00am Carol Bean: Introduction
9.10am Susan Shurin, Deputy Director of the National Heart Lung and Blood Institute: Welcome
9.20am Werner Ceusters: How to Build an Ontology
10.00am Discussion
10.15am Coffee
10.30am Suzanna Lewis: The OBO Foundry
11.00am Jennifer Fostel: The Ontology for Biomedical Investigations
11.30am Richard Scheuermann: Introducing the Clinical Trial Ontology
12.00 noon Discussion
12.30 Lunch
1.30pm Ida Sim: The RCT Schema
2.00pm Dave Parrish: The Epoch Ontology
2.30pm Panel on the Clinical Trial Ontology and the CDISC/BRIDG Initiatives
3.30pm General Discussion
5.00pm Close
May 17 Building 31 Conference Room 10
8.00am Continental Breakfast
9.00am Session 1: Building the Clinical Trial Ontology
11.00am Session 2: Applying the Clinical Trial Ontology
12.30 noon Lunch
1.30pm Session 3: The Future of the Clinical Trial Ontology
4.00pm Close
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.
Sivaram Arabandi -- Cleveland Clinic
Charles E. Barr -- AMIA Clinical Trial Working Group
Carol Bean -- NIH/NHLBI
Werner Ceusters -- Ontology Research Group, University at Buffalo
Chris Chute -- NCBO, Mayo Clinic, Rochester, MN
Lindsay Cowell -- Duke University
Kaushal Desai -- AstraZeneca
Liju Fan -- Ontology Workshop, LLC
Kerstin Forsberg -- AstraZeneca
Jennifer Fostel -- NIH/NIEHS
Gilberto Fragoso -- NIH/NCI
Douglas Fridsma -- University of Pittsburgh
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
Herb Hagler -- University of Texas Southwestern Medical Center
Steve Harris -- Computing Laboratory, University of Oxford
Tina Hernandez-Boussard -- PharmGKB, Stanford University
Warren A. Kibbe -- Northwestern University
Randy Levin -- CDER
Jamie Lee -- University of Texas Southwestern Medical Center
Suzanna Lewis -- NCBO, Berkeley, CA
Eric Little -- Center for Ontology and Interdisciplinary Studies
Peter Maccallum -- UK CancerGrid, Department of Oncology, University of Cambridge
Chris Mungall -- Howard Hughes Institute, Berkeley, CA
Mark Musen -- NCBO, Stanford University, CA
Fabian Neuhaus -– NCBO, University at Buffalo, NY
Chimezie Ogbuji -- Cleveland Clinic Foundation, OH
Dave Parrish -- Immune Tolerance Network, Pittsburgh, PA
Philippe Rocca-Serra -- EBI, Hinxton, Cambridge
Susanna Sansone -- EBI, Hinxton, Cambridge
Nigam Shah -– NCBO, Stanford Medical Informatics
Richard Scheuermann -- University of Texas Southwestern Medical Center
Ida Sim -- Trial Bank, University of California at San Francisco Medical Center
Barry Smith -– NCBO, University at Buffalo, NY
Holger Stenzhorn -- IFOMIS, Saarbrücken
Weida Tong -- Center for Toxicoinformatics, FDA NCTR
Trish Whetzel -- University of Pennsylvania
Samson Tu -- Stanford University
Gabriele Weiler -- Fraunhofer Institute, Sankt Ingbert, Germany
Chunhua Weng -- University of Pittsburgh
Venue
Day 1: Building 45 (Natcher)
Day 2: Building 31
Map of NIH Campus
