Workshop on Clinical Trial Ontology
General Information
REGISTRATION FOR THIS EVENT IS NOW CLOSED!
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.
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.
The work of the NCBO is funded by the National Institutes of Health through the NIH Roadmap for Medical Research, Grant 1 U 54 HG004028. Information on the National Centers for Biomedical Computing can be found here.
We are grateful to the National Heart, Lung and Blood Institute for generous support for this meeting.
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
-- the RCT 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
PLEASE ALLOW AN EXTRA 30 MINUTES TO COMPLETE THE NIH SECURITY ADMISSION PROCESS
Wednesday, May 16 - Building 45 (Natcher), Balcony A
Session 1 (Chair: Barry Smith)
- 8:00am -- Continental Breakfast & Registration
- 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
Session 2 (Chair: Dave Parrish)
- 10:15am -- Refreshment Break
- 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
- 12:00pm -- Discussion
- 12:30pm -- Lunch Break
Session 3 (Chair: Werner Ceusters)
- 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
- 3:30pm -- Refreshment Break
- 4:00pm -- Discussion Session
- 5:00pm -- Close
Thursday, May 17 - Building 31, Conference Room 10
- 8:00am -- Continental Breakfast & Registration
Session 4 (Moderator: Richard Scheuermann)
- 9:00am -- Building the Clinical Trial Ontology
- 10:30am -- Refreshment Break
Session 5 (Moderator: Alan Ruttenberg)
- 11:00am -- Applying the Clinical Trial Ontology
- 12:30pm -- Lunch Break
Session 6 (Moderator: Richard Scheuermann)
- 1:30pm -- The Future of the Clinical Trial Ontology
- 3:00pm -- Refreshments/Close
NIH Security Procedures
All visitor vehicles, including taxicabs, hotel and airport shuttles, delivery trucks and vans will be inspected before being allowed on campus. Visitors will be asked to show a form of government-issued photo identification (driver's license, passport, green card, etc.) and to state the purpose of their visit. Be sure to allow extra time for this vehicle inspection procedure. Employees and visitors should continue to wear their identification prominently at all times while on campus.
Guards will remain at certain buildings to address specific program requirements such as sensitive research and safety concerns. At building entrances where guards are posted:
- Visitors may be required to log in, wear a visitors pass and have an employee escort them through the building.
- Visitors may be required to pass through a metal detector and have bags, backpacks or purses inspected or x-rayed as they enter buildings.
Security staff will be looking for and confiscating any suspicious or potentially dangerous materials. U.S. Code prohibits bringing any dangerous weapons onto Federal property, including anything with a blade longer than 2½ inches. Meeting participants may want to leave extra bags or personal materials at their hotel to minimize the time needed for inspection.
All visitors including patients, contractors, vendors and delivery persons must use the following entrances:
Rockville Pike at South Drive (Metro):
- Open 24 hours - Inbound and Outbound traffic
- Open to All Vehicles
- Pedestrian Turnstiles Open for Employees
- Gateway Center at Metro Open for Visitor Registration--this is where visitors check-in with security if they are not driving
Old Georgetown Road at Center Drive (This entrance is primarily for commercial vehicles and visitors):
- 6am- 7pm -Inbound and Outbound Traffic
- Open to Employee, Commercial and Visitor Vehicles
- Pedestrian Turnstiles Open for Employees
Please note: Visitor parking is limited at NIH. Visitors are encouraged to use public transportation such as the Metrorail subway system which has a convenient stop (Medical Center) on the NIH campus.
Visitors arriving by bus will be dropped off at the NIH/Medical Center Metro stop at Rockville Pike and South Drive. Patients and visitors on official business can then ride the Campus Shuttle to the Clinical Center and other designated shuttle stops on the campus.
Registered Participants
Robert Arp -- NCBO, Buffalo, NY
Pat Avery -- Digital Infuzion, Inc.
Elaine Ayres -- NIH / Clinical Center
William Barrick -- National Institute of Allergy and Infectious Diseases (NIAID) / NIH
Carol Bean -- National Heart, Lung and Blood Institute (NHLBI) / NIH
Maureen Beanan -- National Center for Research Resources (NCRR) / NIH
Elmer Bernstam -- University of Texas Health Science Center at Houston
Olivier Bodenreider -- National Library of Medicine (NLM) / NIH
Olga Brazhnik -- National Center for Research Resources (NCRR) / NIH
Constantino Castillo -- The KEVRIC Company, Inc.
Werner Ceusters -- Ontology Research Group, University at Buffalo
Huey Cheung -- Center for Information Technology (CIT) / NIH
Ling Chin -- National Institute on Deafness and Other Communication Disorders (NIDCD) / NIH
Christopher G. Chute -- NCBO, Mayo Clinic, Rochester, MN
Christian Cocos -- IFOMIS, Saarbrücken, Germany
Elaine Collier -- National Center for Research Resources (NCRR) / NIH
Leo Cousineau -- Information Management Consultants, Reston, VA
Lindsay Cowell -- Duke University Medical Center
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
Douglas Fridsma -- University of Pittsburgh
Charles P. Friedman -- NIH/CRIIT/NHLBI
Louis J. Goldberg -- University at Buffalo
Peter Good -- National Human Genome Research Institute (NHGRI) / NIH
Norbert Graf -- Clinic for Paediatric Oncology and Haematology, Saarland University, Homburg, Germany
Lakshmi M. Grama -- National Cancer Institute (NCI) / NIH
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
William Harlan -- Consultant, National Library of Medicine (NLM) / NIH
Steve Harris -- Computing Laboratory, University of Oxford
Calvin A. Johnson -- Center for Information Technology (CIT) / NIH
Warren A. Kibbe -- Northwestern University
Bron W. Kisler -- Clinical Data Interchange Standards Consortium (CDISC)
William Lau -- Center for Information Technology (CIT) / NIH
Jamie Lee -- University of Texas Southwestern Medical Center at Dallas
Natasha Levenkov -- Rockefeller University
Yuan Liu -- National Institute of Neurological Diseases and Stroke (NINDS) / NIH
Dan Lyman -- Information Management Consultants, Reston, VA
Charles Mead -- NCI/NIH, Center for Biomedical Informatics and Information Technology
Ivan Montoya -- National Institute on Drug Abuse (NIDA) / NIH
Chris Mungall -- Lawrence Berkeley National Laboratory, Berkeley, CA
Robert A. Musson -- National Heart, Lung and Blood Institute (NHLBI) / NIH
Fabian Neuhaus -– National Institute of Standards and Technology (NIST)
Eric Neumann -- Teranode, Seattle, WA
Jeng-Jong Pan -- National Institute on Drug Abuse (NIDA) / NIH
Dave Parrish -- Immune Tolerance Network, Pittsburgh, PA
Ricardo Pietrobon -- Duke University Medical Center
George O. Redmond -- National Cancer Institute (NCI) / NIH
Alexander Rosenthal -- National Institute of Allergy and Infectious Diseases (NIAID) / NIH
Alan Ruttenberg -- Science Commons (c/o MIT CSAIL)
Laurie M. Ryan -- National Institute on Aging (NIA) / NIH
Jody Sachs -- National Center for Research Resources (NCRR) / NIH
Michael Sayre -- National Center for Research Resources (NCRR) / NIH
Richard Scheuermann -- University of Texas Southwestern Medical Center
Susan Shurin -- National Heart, Lung and Blood Institute (NHLBI) / NIH
Hua-Chuan Sim -- National Library of Medicine (NLM) / 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
Samson Tu -- Stanford University
Suresh Varghese -- Digital Infuzion, Inc.
Chunhua Weng -- University of Pittsburgh
Trish Whetzel -- University of Pennsylvania
Rebecca Williams -- National Library of Medicine (NLM) / NIH
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)
