Clinical Trials Working Group

Objective: To allow adequate representation of clinical trial data in OMOP.

First use case: To convert clinical trial data in CDISC SDTM format to OMOP, with a view to allowing trial planning optimization.

Approach: We advocate minimum changes to the OMOP CDM and Standardized Vocabularies because we want to ensure minimum impact on OHDSI tools like Atlas, whilst providing a value-add SDTM-to-OMOP conversion with minimum data loss. We have proposed conventions introducing new concepts and modifiers, but no new CDM tables; and providing guidance for ETL developers where appropriate. Our proposals were originally built on OMOP CDM v6 and the Oncology extension, with v5.3 backward compatibility. In a new v5.4 the additions from the Oncology extension became standard, which made our changes minimal, thereby, making our proposals fully compatible with v5.4.

Status:
- 2024: The finalization of C-Path SDTM-to-OMOP mappings is underway, with an emphasis on matching concept codes using Usagi. The next step is to execute ETL queries to generate the OMOP CDM tables. Additionally, a secondary objective is to identify general conventions and best practices for clinical trials. These conventions will be applied to additional C-Path SDTM study data to uncover any further gaps or challenges.
- 2023: The team has transitioned from using Vivli (due to access constraints) data to leveraging SDTM data provided by C-Path for tuberculosis. The development of mapping specifications for the subsequent ETL process will proceed from the initial stages.
- 2022: CTWG has been granted access to 20 Vivli clinical study packages in SDTM format. The team is conducting an inventory of these study packages to prioritize SDTM-to-OMOP mappings. The current CTWG guidance topics will be further evaluated, with new topics identified as needed.
- 2021: CTWG conducted an assessment of clinical trial data providers to identify sources of accessible SDTM data. This assessment led to discussions with Vivli, focusing on general data usage agreements and evaluating the feasibility of their platform.
- 2020: Used a synthetic representation of the CDISC SDTM data via PHUSE Test Data. Initial guidance topics were codified but require further testing with diverse real world SDTM data. The CTWG proposals submitted to the OHDSI community in July 2020.

Conventions proposal submitted to OHDSI
https://github.com/OHDSI/CommonDataModel/issues/358

Group GitHub repository
https://github.com/OHDSI/ClinicalTrialsWGETL

Recent WG Updates: 2024 EU OHDSI Symposium Poster; Nov. 2022 Presentation; Oct. 2021 Presentation and Slides

Meetings

Bi-weekly on Fridays from 11:30 AM to 12:00 PM EST (Eastern Standard Time) or 4:30 PM to 5:00 PM UTC (Universal Time Coordinated) is accessible on the OHDSI Teams environment.

* Note on accessing Teams channel:

Membership

WG co-leads: Mike Hamidi and Kenneth Wilkins

Active members

Name Organization Location
Chidi Asuzu USA
Rebecca Baker CDISC Austin, TX, USA
Ian Braun Critical Path Institute Tucson, AZ, USA
Melissa Cook Essex Management Boston, MA, USA
Diane Corey Critical Path Institute Tucson, AZ, USA
Shital Desai Independent USA
Kerry Goetz National Institute of Health;
National Eye Institute 		Bethesda, MD, USA
Mike Hamidi DataInterop LLC New Jersey, USA
Dan Hartley Critical Path Institute USA
Ying Huang National Institute of Health USA
Asiyah Yu Lin National Institute of Health Bethesda, MD, USA
Zhen Lin * Robot Bacon Houston, TX, USA ,
Zhixin Lun University of Colorado Anschutz Medical Campus Aurora, CO, USA
Terrence McHugh Critical Path Institute Tucson, AZ, USA
Priya Meghrajani Talosix Seattle, WA, USA
Paul Orona USA
Daniel Olson Critical Path Institute Tucson, AZ, USA
Katy Sadowski TrialSpark New York, NY, USA
Philip Solovyev Odysseus Data Services Inc. Vilnius, Lithuania
Cynthia Sung OHDSI Seattle, WA, USA
Ramona Walls Critical Path Institute Tucson, AZ, USA , ,
Tom Walpole * ZS Associates Princeton, NJ, USA
Kenneth Wilkins National Institute of Health Bethesda, MD, USA
Ying Xiao Penn Medicine, University of Pennsylvania Philadelphia, PA, USA
Qi Yang IQVIA Plymouth Meeting, PA, USA

Other members

Name Organization Location
Eldar Allakhverdiiev Odysseus Data Services Inc. Cambridge, MA, USA
Sonia Araujo * IQVIA London, UK
Junn Bautista Genentech South San Francisco, CA, USA
Elise Berliner
Ted Bebi Medidata Boston, MA, USA
Lina Clover SAS Raleigh-Durham, NC, USA
Alexander Davydov Odysseus Data Services Inc. Cambridge, MA, USA
Shawn Dolley Open Global Health Arlington, Virginia, USA
Rhonda Facile CDISC Austin, Texas, USA
Stephen Fortin
Vojtech Huser National Library of Medicine,
National Institutes of Health 		Bethesda, MD, USA
Michael Kallfelz Odysseus Data Services Inc. Berlin, Germany
Gregory Klebanov Odysseus Data Services Inc. Cambridge, MA, USA
Bess LeRoy CDISC Tucson, AZ, USA
James Liddil M2Gen Tampa, FL, USA
Maxim Moinat The Hyve Utrecht, The Netherlands
Alexandra Orlova Odysseus Data Services Inc. Cambridge, MA, USA
Joshua F. Ransom BEKHealth Inc Wayland, MA, USA
Chris Roeder School of Medicine, University of Colorado CO, USA
Anthony Sunjaya The George Institute for Global Health,
UNSW Sydney 		Sydney, NSW, Australia
Emma Vos The Hyve Utrecht, The Netherlands
Andrew Williams Tufts Institute for Clinical Research
and Health Policy Studies 		Boston, MA, USA
Ariana Winder Javara Research State College, Pennsylvania, USA
Stella Zhu Bill & Melinda Gates Medical Research Institute Seattle, WA, USA

* Past leads

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