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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 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 |
| 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 |
Important Links
Conventions proposal submitted to OHDSI
https://github.com/OHDSI/CommonDataModel/issues/358
Group GitHub repository
https://github.com/OHDSI/ClinicalTrialsWGETL
Meetings
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
