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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:
- 2022: CTWG was given access to 20 Vivli clinical study packages in the SDTM format. The CTWG team is doing an inventory of those study packages in order to prioritize SDTM-to-OMOP mappings. The existing CTWG guidance topics will be further assessed and new ones identified where necessary.
- 2021: CTWG did an assessment of clinical trial data providers where SDTM data could be accessed. This eventually led to discussions with Vivli (i.e., general data usage agreements and platform feasibility evaluation).
- 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.
Important Links
Conventions proposal submitted to OHDSI
https://github.com/OHDSI/CommonDataModel/issues/358
Group GitHub repository
https://github.com/OHDSI/ClinicalTrialsWGETL
Recent WG Updates: Nov. 2022 Presentation; Oct. 2021 Presentation and Slides
Meetings
Spring 23 Schedule:
Weekly rotating schedule on Fridays, 8AM PT/10AM CT/11AM ET/4PM UK/11PM CST;
and Fridays, 10AM PT/12AM CT/1PM ET/6PM UK/1AM CST;
on Teams
For example:
* Jan 27th: 11AM ET
* Feb 3rd: 1PM ET
* Feb 10th: 11AM ET
* Feb 17th: 1PM ET
* Note on accessing Teams channel above:
- If you use the Teams desktop app and have multiple accounts, ensure you are already in the OHDSI Teams account before clicking the link above
- Alternatively, select the “web app” button in the link above for accessing meetings on your browser
Membership
WG co-leads: Mike Hamidi, Pfizer, US (Kamiar.Hamidi@pfizer.com), Tom Walpole, ZS Associates, US, and Zhen Lin, Memorial Hermann TMC | Robot Bacon, US (Zhen.Lin@ohdsi.org)
Active members
| Name | Organization | Location | |
|---|---|---|---|
| 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 | |
| Kerry Goetz | National Institute of Health; National Eye Institute | Bethesda, MD, USA | |
| Priya Gopal | Flatiron Health | New York, NY, USA | |
| Mike Hamidi | Pfizer | USA | |
| Michael Kallfelz | Odysseus Data Services Inc. | Berlin, Germany | |
| Zhen Lin | MH-TMC/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 | |
| Daniel Olson | Critical Path Institute | Tucson, AZ, USA | |
| Katy Sadowski | TrialSpark | New York, NY, USA | |
| Philip Solovyev | Odysseus Data Services Inc. | 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 | |
| Gregory Klebanov | Odysseus Data Services Inc. | Cambridge, MA, USA | |
| Bess LeRoy | CDISC | Tucson, AZ, USA | |
| James Liddil | M2Gen | Tampa, FL, USA | |
| Asiyah Yu Lin | National Institute of Health | Bethesda, MD, 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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