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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: - Proposals submitted to the OHDSI community in July 2020. - Currently applying our proposed conventions to the PHUSE database (a synthetic SDTM database).
WG Lead: Sonia Araujo, IQVIA, London, UK (sonia.araujo@iqvia.com)
Current Members
Name | Organization & Location | |
---|---|---|
Alexander Davydov | Odysseus Data Services Inc., Cambridge, MA, USA | |
Alexandra Orlova | Odysseus Data Services Inc., Cambridge, MA, USA | |
Andrew Williams | Tufts Institute for Clinical Research and Health Policy Studies, Boston, MA, USA | |
Asiyah Yu Lin | Center for Devices and Radiological Health, FDA, Silver Spring, MD, USA; National Center for Ontological Research, Buffalo, New York, USA | |
Bess LeRoy | CDISC, Tucson, AZ, USA | |
Chris Roeder | School of Medicine, University of Colorado, CO, USA | |
Cynthia Sung | Bill & Melinda Gates Medical Research Institute, Seattle, WA, USA | |
{nowrap | Eldar Allakhverdiiev} | Odysseus Data Services Inc., Cambridge, MA, USA |
Emma Vos | The Hyve, Utrecht, The Netherlands | |
Gregory Klebanov | Odysseus Data Services Inc., Cambridge, MA, USA | |
James Liddil | M2Gen, Tampa, FL, USA | |
Joshua F. Ransom | BEKHealth Inc, Wayland, MA, USA | |
Katy Sadowski | TrialSpark, New York, New York, USA | |
Lina Clover | SAS, Raleigh-Durham, NC, USA | |
Maxim Moinat | The Hyve, Utrecht, The Netherlands | |
Michael Kallfelz | Odysseus Data Services Inc., Cambridge, MA, USA | |
Mike Hamidi | CDISC, Audubon, PA, USA | |
Philip Solovyev | Odysseus Data Services Inc., Cambridge, MA, USA | |
Rebecca Baker | CDISC, Austin, Texas, USA | |
Rhonda Facile | Elligo, Austin, Texas, USA | |
Sonia Araujo | IQVIA, London, UK | |
Ted Bebi | Medidata, Boston, MA, USA | |
Tom Walpole | Trials.ai, San Diego, CA, USA | |
Vojtech Huser | National Library of Medicine, National Institutes of Health, Bethesda, MD, USA |
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, 3pm UK time (10am Eastern)
Recordings
Q4 2020 | Q3 2020 | Q2 2020 | Q1 2020 |
---|---|---|---|
02 Oct | 18 Sep | 26 Jun | 20 Mar |
04 Sep | 22 May | 06 Mar (partial) | |
21 Aug | 15 May | 07 Feb | |
14 Aug | 01 May | 10 Jan | |
03 Apr |
Q4 2019 06 Dec - initial presentations from the Hyve, Medidata and Odysseus
Want to contribute to the group? Email sonia.araujo@iqvia.com