Difference between revisions of "Workshop on Clinical Trial Ontology"

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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.
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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 [http://nihroadmap.nih.gov/bioinformatics here].
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We are grateful to the National Heart, Lung and Blood Institute for generous support for this meeting.
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== '''Aim of the Workshop''' ==
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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.
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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. It will address the potential uses of CTO, and methodology for CTO design and development.
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== '''Goals of the Clinical Trial Ontology Initiative''' ==
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The proposed CTO should:
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(1) fully and faithfully capture the types of entities and relationships involved in clinical trials of any experimental design
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(2) comprehend terms like: ''cohort, randomization, placebo, response, efficacy, control, protocol, null hypothesis, confidence interval, finding, biomarker, primary outcome, secondary outcome, intervention group, confounder,'' etc., including also major relevant statistical terms and terms drawn from resources such as the CDISC [http://www.cdisc.org/glossary/clinicalterminologyv4.pdf glossary] and
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all terms needed for the task of meta-analysis of clinical trials;
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(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.
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(4) support trial bank interoperation
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(5) form an integral part of the more comprehensive framework of the Ontology for Biomedical Investigations [http://obi.sourceforge.net/ OBI], which itself forms part of the [http://obofoundry.org/ OBO Foundry]
+
[http://www.chfang.com.cn/produce/measure.htm 测量显微镜]显微镜
 
+
[http://www.chfang.com.cn/produce/tools.htm 工具显微镜]显微镜
(6) draw on and seek maximal alignment with existing clinical trial ontologies, including:
+
[http://www.chfang.com.cn/produce/read.htm 读数显微镜]]显微镜
 
+
[http://www.chfang.com.cn/produce/projector.htm 测量投影仪]
-- the [http://smi.stanford.edu/smi-web/research/details.jsp?PubId=1227 Epoch ontology] used by the [http://www.immunetolerance.org Immune Tolerance Network]  
+
[http://www.chfang.com.cn/produce/image.htm 影像测量仪]
 
 
-- the [http://rctbank.ucsf.edu/ontology/outline/index.htm RCT Schema] ontology used by the[http://rctbank.ucsf.edu/ Trial Bank Initiative]
 
 
 
(7) rest on a clear understanding of the relation between CTO and related ventures such as 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) be created through an open process, in which all interested parties can be involved.
 
 
 
== '''Agenda''' ==
 
 
 
'''<big><u>Wednesday, May 16 - Building 45 (Natcher), Balcony A</u></big>'''
 
 
 
* 8:00am -- Registration & Continental Breakfast
 
 
 
'''Session 1 (Chair: Barry Smith)'''
 
 
 
* 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'' [http://ontology.buffalo.edu/07/CTO/ceusters.ppt ppt]
 
 
 
* 10:00am -- Discussion
 
 
 
* 10:15am -- Refreshment Break
 
 
 
'''Session 2 (Chair: Dave Parrish)'''
 
 
 
* 10:30am -- Chris Mungall: ''The OBO Foundry'' [http://ontology.buffalo.edu/07/CTO/mungall.ppt ppt]
 
 
 
* 11:00am -- Jennifer Fostel: ''The Ontology for Biomedical Investigations'' [http://ontology.buffalo.edu/07/CTO/fostel.ppt ppt]
 
 
 
* 11:30am -- Richard Scheuermann: ''Introducing the Clinical Trial Ontology'' [http://ontology.buffalo.edu/07/CTO/scheuermann.ppt  ppt]  
 
 
 
* 12:00pm -- Discussion
 
 
 
* 12:30pm -- Lunch Break
 
 
 
'''Session 3 (Chair: Werner Ceusters)'''
 
 
 
* 1:30pm -- Ida Sim: ''The RCT Schema'' [http://ontology.buffalo.edu/07/CTO/sim.ppt  ppt]
 
 
 
* 2:00pm -- Amar Das: ''Epoch: An Ontological Framework for Clinical Trial Management''
 
[http://ontology.buffalo.edu/07/CTO/Das.pdf ppt]
 
 
 
* 2:30pm -- Barry Smith: ''The Clinical Trial Ontology: Creating Consensus'' [http://ontology.buffalo.edu/07/CTO/smith.ppt  ppt]  
 
 
 
* 3:30pm -- Refreshment Break
 
 
 
* 4:00pm -- Discussion Session
 
 
 
* 5:00pm -- Close
 
 
 
 
 
'''<big><u>Thursday, May 17 - Building 31, Conference Room 10</u></big>'''
 
 
 
* 8:00am -- Registration & Continental Breakfast
 
 
 
'''Session 4 (Moderator: Jennifer Fostel)'''
 
 
 
* 9:00am -- Building the Clinical Trial Ontology
 
 
 
* 10:30am -- Refreshment Break
 
 
 
''' Session 5 (Moderator: Alan Ruttenberg)'''
 
 
 
* 11:00am -- Applying the Clinical Trial Ontology
 
**Norbert Graf: ACGT's Clinical Trial Builder [http://ontology.buffalo.edu/07/CTO/graf.ppt ppt]
 
 
 
* 12:30pm -- Lunch Break
 
 
 
'''Session 6 (Moderator: Richard Scheuermann)'''
 
 
 
* 1:30pm -- The Future of the Clinical Trial Ontology [[Media:CTO_Workshop_Day_2_RS_JL.doc]]
 
 
 
* 3:00pm -- Close
 
 
 
== '''NIH Security Regulations''' ==
 
 
 
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:
 
 
<u>Rockville Pike at South Drive</u> (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
 
 
 
<u>Old Georgetown Road at Center Drive</u> (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.
 
 
 
== '''Participants (Final)''' ==
 
 
 
Robert Arp -- NCBO, University at Buffalo
 
 
 
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
 
 
 
In Hye Cho -- National Library of Medicine (NLM) / NIH
 
 
 
Christopher G. Chute -- NCBO, Mayo Clinic
 
 
 
Kevin Clany -- Invitrogen Corp.
 
 
 
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
 
 
 
Gabriele Feolo -- National Heart, Lung and Blood Institute (NHLBI) / NIH
 
 
 
Kerstin Forsberg -- AstraZeneca
 
 
 
Jennifer Fostel -- NIH/NIEHS
 
 
 
Douglas Fridsma -- University of Pittsburgh
 
 
 
Jane Fun -- Contractor, National Library of Medicine (NLM) / NIH
 
 
 
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)
 
 
 
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
 
 
 
Frank Hartel -- NCI Center for Bioinformatics / NIH
 
 
 
Calvin A. Johnson -- Center for Information Technology (CIT) / NIH
 
 
 
Heather A. Junkins -- CRIIT & NHLBI / NIH
 
 
 
Webster Kelsey -- Dept of Biomedical Informatics, University of Pittsburgh
 
 
 
Warren A. Kibbe -- Northwestern University
 
 
 
Bron W. Kisler -- Clinical Data Interchange Standards Consortium (CDISC)
 
 
 
George A. Komatsoulis -- NCI Center for Bioinformatics / NIH
 
 
 
Jennie Larkin -- National Heart, Lung and Blood Institute (NHLBI) / NIH
 
 
 
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
 
 
 
Yun Lu -- KAI Research, Inc.
 
 
 
Dan Lyman -- Information Management Consultants (Reston, VA)
 
 
 
Peter Lyster -- Center for Bioinformatics and Computational Biology, National Institute of General Medical Sciences (NIGMS) / NIH
 
 
 
Peter Maccallum -- CRUK Cambridge Research Institute, University of Cambridge
 
 
 
Charles Mead -- NCI/NIH, Center for Biomedical Informatics and Information Technology
 
 
 
Chris Mungall -- NCBO, Lawrence Berkeley National Laboratory
 
 
 
Robert A. Musson -- National Heart, Lung and Blood Institute (NHLBI) / NIH
 
 
 
Darren Natale -- Georgetown University Medical Center
 
 
 
Fabian Neuhaus -– National Institute of Standards and Technology (NIST)
 
 
 
Eric Neumann -- Teranode (Seattle, WA)
 
 
 
Eduardo Ortiz -- National Heart, Lung and Blood Institute (NHLBI) / NIH
 
 
 
Jeng-Jong Pan -- National Institute on Drug Abuse (NIDA) / NIH
 
 
 
Dave Parrish -- Immune Tolerance Network (Pittsburgh, PA)
 
 
 
George O. Redmond -- National Cancer Institute (NCI) / NIH
 
 
 
Dianne M. Reeves -- National Cancer Institute, Center for Biomedical Informatics and Information Technology (formerly NCICB) / NIH
 
 
 
Alan Ruttenberg -- Science Commons (c/o MIT CSAIL)
 
 
 
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
 
 
 
Ranjana Srivastava -- Information Management Consultants (Reston, VA)
 
 
 
Samson Tu -- Stanford University
 
 
 
Suresh Varghese -- Digital Infuzion, Inc.
 
 
 
Chunhua Weng -- University of Pittsburgh
 
 
 
Rebecca Williams -- National Library of Medicine (NLM) / NIH
 
 
 
Ashley Xia -- National Institute of Allergy and Infectious Diseases (NIAID) / NIH
 
 
 
Sandhya Xirasagar -- Information Management Consultants (Reston, VA)
 
 
 
Alison Yao -- National Institute of Allergy and Infectious Diseases (NIAID) / NIH
 
 
 
Zhensheng Zhang -- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) / NIH
 
 
 
== '''Venue''' ==
 
 
 
Day 1: Balcony A, Building 45 (Natcher), NIH Campus, Bethesda, MD
 
 
 
Day 2: Conference Room 10, Building 31, NIH Campus, Bethesda, MD
 
 
 
A printable NIH Visitors Map can be found at: [http://parking.nih.gov/documents/visitorAccessMap.pdf NIH Visitors Map]
 
 
 
A printable schedule of shuttle service between area hotels and NIH can be found at:  [http://dtts.ors.od.nih.gov/documents/south_hotel_shuttles.pdf NIH Shuttles]
 
 
 
== '''Links''' ==
 
 
 
[http://www.bioontology.org/ncbo/faces/index.xhtml NCBO Bioportal]
 
 
 
[http://obo.sourceforge.net Open Biomedical Ontologies]
 
 
 
[http://obofoundry.org OBO Foundry]
 
 
 
[http://obi.sourceforge.net Ontology for Biomedical Investigations]
 
 
 
[http://rctbank.ucsf.edu/ Trial Bank]
 
 
 
[http://protege.stanford.edu/conference/2006/submissions/slides/3.2_Shankar_EpochModels.pdf Epoch Ontology]
 
 
 
[http://www.ifomis.uni-saarland.de/wiki/index.php/ACGT The ACGT Project]: Advancing Clinico-Genomic Trials on Cancer
 
 
 
[http://www.bioontology.org/wiki/index.php/CTO:Main_Page Clinical Trial Ontology Wiki]
 
 
 
[http://esw.w3.org/topic/HCLS/OntologyTaskForce/BIONTDSEDCM HCLS Ontology Task Force]
 
 
 
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) ==
 
 
 
[http://cto.googlecode.com/svn/trunk/CTO.owl Current OWL version]
 
 
 
[[Image:CTO.jpg]]
 

Revision as of 21:06, 25 July 2008

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