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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 are built on OMOP CDM v6 and the Oncology extension, with v5.3.1 backward compatibility.
Status:
- Currently applying our proposed conventions to the PHUSE database (a synthetic SDTM database).
- 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
Schedule: Biweekly calls on Fridays, 7:30AM PT/9:30AM CT/10:30AM ET/3:30PM UK time on Teams here
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WG co-leads: Mike Hamidi, Pfizer, US (Kamiar.Hamidi@pfizer.com) and Zhen Lin, Robot Bacon, US (Zhen.Lin@ohdsi.org)
Active members
Other members
Name | Organization | Location | |
---|---|---|---|
Eldar Allakhverdiiev | Odysseus Data Services Inc. | Cambridge, MA, USA | |
Sonia Araujo * | IQVIA | London, UK | |
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 | |
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; National Center for Ontological Research | Bethesda, Maryland, 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 | |
Cynthia Sung | Bill & Melinda Gates Medical Research Institute | Seattle, WA, USA | |
Emma Vos | The Hyve | Utrecht, The Netherlands | |
Andrew Williams | Tufts Institute for Clinical Research and Health Policy Studies | Boston, MA, USA |
* Past leads
Want to contribute to the group? Opt-in here, or email Mike and/or Zhen.