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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.

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

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

Recent WG Presentation Slides


Meetings

Schedule:
Friday, Dec. 2nd, 2022: 7AM PT/9AM CT/10AM ET/3PM UK/10PM CST;
Friday, Dec. 9th, 2022: 8AM PT/10AM CT/11AM ET/4PM UK/11PM CST;
Friday, Dec. 16th, 2022: 10AM PT/12AM CT/1PM ET/6PM UK/1AM CST;
on Teams

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) and Zhen Lin, Robot Bacon, US (Zhen.Lin@ohdsi.org)

Active members

Name Organization Location
Rebecca Baker CDISC Austin, TX, USA
Junn Bautista Genentech South San Francisco, CA, USA
Elise Berliner
Ian Braun Critical Path Institute Tucson, AZ, USA
Melissa Cook Essex Management Boston, MA, USA
Diane Corey Critical Path Institute Tucson, AZ, USA
Stephen Fortin
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
Asiyah Yu Lin National Institute of Health;
National Center for Ontological Research
Bethesda, MD, USA
Zhen Lin Robot Bacon Houston, TX, USA ,
Terrence McHugh Critical Path Institute Tucson, AZ, USA
Daniel Olson Critical Path Institute Tucson, AZ, USA
Katy Sadowski TrialSpark New York, NY, USA
Philip Solovyev Odysseus Data Services Inc. St. Petersburg, Russia
Cynthia Sung Bill & Melinda Gates Medical Research Institute Seattle, WA, USA
Ramona Walls Critical Path Institute Tucson, AZ, USA , ,
Tom Walpole Trials.ai San Diego, CA, USA
Kenneth Wilkins National Institute of Health Bethesda, MD, USA
Ariana Winder nPhase, REDCap Cloud Bellefonte, PA, USA
Qi Yang IQVIA Plymouth Meeting, PA, USA
Stella Zhu Bill & Melinda Gates Medical Research Institute Seattle, WA, USA

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
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

* Past leads


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projects/workgroups/clinicalstudy.txt · Last modified: 2022/11/28 23:50 by zhen