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 and dissemination of a reference ontology (high-quality controlled structured vocabulary) for the annotation of the results of clinical trials.
The Workshop will bring together representatives of all of the major groups involved in clinical trial informatics, design, execution, analysis and standardization, with the goal of achieving a broad consensus on the requirements which the ontology should address and on the most effective means of realizing these requirements.
Goals of the Clinical Trial Ontology Initiative
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 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 and all terms needed for the task of meta-analysis of clinical trials;
(3) organize these terms in a structured way, providing definitions and logical relations designed to enhance retrieval of, reasoning with, and integration of the data annotated in its terms.
(4) support trial bank interoperation
(5) form an integral part of the more comprehensive framework of the Ontology for Biomedical Investigations OBI, which itself forms part of the OBO Foundry
(6) draw on and seek maximal alignment with existing clinical trial ontologies, including the Epoch ontology used by the Immune Tolerance Network and theRCT Schema ontology used by theTrial Bank Initiative
(7) rest on a clear understanding of the relation between CTO and an epidemiology study ontology
(8) rest on a clear understanding of the relation between CTO and data-model-oriented initiatives such as CDISC and BRIDG.
(9) meet the requirements of the OBO Foundry, and in particular support an adequate treatment of the distinction between types (surgical intervention, tumor, human being) and instances (Jane's oophorectomy, John's tumor, Fritz)
Agenda [Draft]
The meeting will be divided into two parts:
Day 1 will be a public event consisting of presentations and panel discussions on the CTO and cognate initiatives.
Day 2 will be a working meeting devoted to intense discussions of mature drafts of the CTO and to the creation of a strategy for its further development and testing.
Please note that active participation in Day 2 of the meeting is restricted. If you wish to be considered for participation, please send a brief statement to Barry Smith.
Observers will be welcome in both parts of the meeting providing they give prior notice, details concerning which will be provided in due course.
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 Chris Mungall: 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 Amar Das: Epoch: An Ontological Framework for Clinical Trial Management
2.30pm Barry Smith: The Clinical Trial Ontology: Creating Consensus
3.00pm Discussion
3.30pm Coffee
4.00pm Panel Session
5.00pm Close
May 17 Building 31 Conference Room 10
8.00am Continental Breakfast
9.00am Session 1: Building the Clinical Trial Ontology
Moderator: Richard Scheuermann
10.30am Coffee
11.00am Session 2: Applying the Clinical Trial Ontology
12.30 noon Lunch
1.30pm Session 3: The Future of the Clinical Trial Ontology
3.00pm Coffee
Participants
Sivaram Arabandi -- Cleveland Clinic
Robert Arp -- NCBO, Buffalo, NY
Pat Avery -- Digital Infusion, Inc.
Charles E. Barr -- AMIA Clinical Trial Working Group
William Barrick -- NIH/NIAID
Carol Bean -- NIH/NHLBI
Maureen Beanan -- NIH/National Center for Research Resources
Olivier Bodenreider -- NIH/NLM
Olga Brazhnik -- NIH/National Center for Research Resources
Constantino Castillo -- The KEVRIC Company, Inc.
Werner Ceusters -- Ontology Research Group, University at Buffalo
Huey Cheung -- NIH/CIT
Chris Chute -- NCBO, Mayo Clinic, Rochester, MN
Christian Cocos -- IFOMIS, Saarbrücken, Germany
Elaine Collier -- NIH/National Center for Research Resources
Leo Cousineau -- Information Management Consultants, Reston, VA
Lindsay Cowell -- Duke University
Amar Das -- Stanford Medical Informatics
Kaushal Desai -- AstraZeneca
Stephen Dobson -- Pfizer Global Research and Development
Liju Fan -- Ontology Workshop, LLC
Kerstin Forsberg -- AstraZeneca
Jennifer Fostel -- NIH/NIEHS
Gilberto Fragoso -- NIH/NCI
Douglas Fridsma -- University of Pittsburgh
Charles P. Friedman -- /NIH/CRIIT/NHLBI
Louis J. Goldberg -- University at Buffalo
Peter Good -- NIH/National Human Genome Research Institute
Federico Goodsaid -- FDA CDER, Office of Clinical Pharmacology
Norbert Graf -- ACGT, Homburg, Germany
Ted Grasela -- Cognigen Corporation, Amherst, NY
Patricia Haggerty -- National Heart, Lung and Blood Institute (NHLBI) / NIH
Herb Hagler -- University of Texas Southwestern Medical Center
Andrea Harabin -- National Heart, Lung and Blood Institute (NHLBI) / NIH
Steve Harris -- Computing Laboratory, University of Oxford
Tina Hernandez-Boussard -- PharmGKB, Stanford University
Calvin A. Johnson -- Center for Information Technology (CIT) / NIH
Warren A. Kibbe -- Northwestern University
Bron W. Kisler -- CDISC Terminology Program
William Lau -- Center for Information Technology (CIT) / NIH
Jamie Lee -- University of Texas Southwestern Medical Center
Randy Levin -- CDER
Eric Little -- Center for Ontology and Interdisciplinary Studies, Buffalo
Dan Lyman -- Information Management Consultants, Reston, VA
Peter Maccallum -- UK CancerGrid, Department of Oncology, University of Cambridge
Charles Mead -- NIH/NCI Center for Biomedical Informatics and Information Technology
Chris Mungall -- Howard Hughes Institute, Berkeley, CA
Mark Musen -- NCBO, Stanford University, CA
Robert A. Musson -- NIH/NHLBI
Fabian Neuhaus -– NCBO, University at Buffalo, NY
Eric Neumann -- Teranode, Seattle, WA
Chimezie Ogbuji -- Cleveland Clinic Foundation, OH
Dave Parrish -- Immune Tolerance Network, Pittsburgh, PA
Alexander Rosenthal -- National Institute of Allergy and Infectious Diseases (NIAID) / NIH
Jody Sachs -- NIH/National Center for Research Resources
Michael Sayre -- NIH/National Center for Research Resources
Richard Scheuermann -- University of Texas Southwestern Medical Center
Nigam Shah -– NCBO, Stanford Medical Informatics
Susan Shurin -- National Heart, Lung and Blood Institute (NHLBI) / NIH
Ida Sim -- Trial Bank, University of California at San Francisco Medical Center
Barry Smith -– NCBO, University at Buffalo, NY
Ranjana Srivastava -- Information Management Consultants, Reston, VA
Weida Tong -- Center for Toxicoinformatics, FDA NCTR
Samson Tu -- Stanford University
Chunhua Weng -- University of Pittsburgh
Trish Whetzel -- University of Pennsylvania
Sandhya Xirasagar -- Information Management Consultants, Reston, VA
Alison Yao -- National Institute of Allergy and Infectious Diseases (NIAID) / NIH
Venue
Day 1: Balcony A, Building 45 (Natcher), NIH Campus, Bethesda, MD
Day 2: Conference Room 10, Building 31, NIH Campus, Bethesda, MD
Links
Ontology for Biomedical Investigations
The ACGT Project: Advancing Clinico-Genomic Trials on Cancer
A video introduction to ontologies by Barry Smith is available here:
- Realmedia: rtsp://stream.buffalo.edu/shared/research/phismith/Stanford10-25-06/Tutorial.rm
- Mediaplayer: rtsp://stream.buffalo.edu/shared/research/phismith/Stanford10-25-06/Tutorial.WMV
The second half of this presentation pertains to the building of the Clinical Trial Ontology.
Preliminary Fragment of CTO (for illustration purposes only)
