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 and to bring together representatives. It 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 consensus on the .

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. 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.

The Clinical Trial Ontology

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.

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]

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

Travel to NIH Campus

Map of NIH Campus