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 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 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
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
Active Participants
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
Mathias Brochhausen -- IFOMIS / European Center for Ontological Research, Saarbrücken
Werner Ceusters -- Ontology Research Group, University at Buffalo
Chris Chute -- NCBO, Mayo Clinic, Rochester, MN
Leo Cousineau -- Information Management Consultants, Reston, VA
Lindsay Cowell -- Duke University
Amar Das -- Stanford Medical Informatics
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
Dan Lyman -- Information Management Consultants, Reston, VA
Peter Maccallum -- UK CancerGrid, Department of Oncology, University of Cambridge
Charles Mead -- NCI Center for Biomedical Informatics and Information Technology
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
Ranjana Srivastava -- Information Management Consultants, Reston, VA
Holger Stenzhorn -- IFOMIS, Saarbrücken
Weida Tong -- Center for Toxicoinformatics, FDA NCTR
Trish Whetzel -- University of Pennsylvania
Samson Tu -- Stanford University
Chunhua Weng -- University of Pittsburgh
Sandhya Xirasagar -- Information Management Consultants
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)
