Observational Health Data Sciences and Informatics

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====== Clinical Trials Working Group ======

<WRAP box justify round>

**Objective**: To allow adequate representation of clinical trial data in OMOP. 

**First use case**: To convert clinical trial data in [[https://www.cdisc.org/standards/foundational/sdtm|CDISC SDTM]] format to [[https://www.ohdsi.org/data-standardization/the-common-data-model/|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**:\\ 
- 2025: CTWG is providing new chapter content (Clinical Trial Data) for the upcoming Book of OHDSI update.
- 2024: The finalization of C-Path SDTM-to-OMOP mappings is underway, with an emphasis on matching concept codes using Usagi. The next step is to execute ETL queries to generate the OMOP CDM tables. Additionally, a secondary objective is to identify general conventions and best practices for clinical trials. These conventions will be applied to additional C-Path SDTM study data to uncover any further gaps or challenges. \\
- 2023: The team has transitioned from using Vivli (due to access constraints) data to leveraging SDTM data provided by C-Path for tuberculosis. The development of mapping specifications for the subsequent ETL process will proceed from the initial stages.\\
- 2022: CTWG has been granted access to 20 Vivli clinical study packages in SDTM format. The team is conducting an inventory of these study packages to prioritize SDTM-to-OMOP mappings. The current CTWG guidance topics will be further evaluated, with new topics identified as needed.  \\
- 2021: CTWG conducted an assessment of clinical trial data providers to identify sources of accessible SDTM data. This assessment led to discussions with Vivli, focusing on general data usage agreements and evaluating the feasibility of their platform. \\
- 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.\\
</WRAP>



==== 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: 
[[https://www.ohdsi-europe.org/images/symposium-2024/Posters/CTWG%20OHDSI%20Europe%20poster_v3%20-%20Cynthia%20Sung.pdf|2024 EU OHDSI Symposium Poster]]; [[https://youtu.be/pWW72a9A5YE|Nov. 2022 Presentation]]; [[https://youtu.be/ctPADsAoYpM|Oct. 2021 Presentation]] and [[https://ohdsiorg.sharepoint.com/:b:/s/Workgroup-Clinicaltrials/EXbVRrl7hQNEiPhC48Zx0t4BfILfVjMiW85MtWBmGHRzFA?e=nThgMV|Slides]]
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==== Meetings ====

**Bi-weekly on Fridays from 11:30 AM to 12:00 PM EST (Eastern Standard Time) or 4:30 PM to 5:00 PM UTC (Universal Time Coordinated)** is accessible on the OHDSI Teams environment. \\

*** Note on accessing Teams channel:**\\
  * 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\\
  * Join our WG here if you haven't: https://ohdsi.org/join-the-journey/.   

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==== Membership ====

**WG co-leads**: 
Open Spot
and 
Kenneth Wilkins

**WG past leads**: 
Mike Hamidi, Tom Walpole, Zhen Li, Sonia Araujo

**Active members**\\

^ Name              ^ Organization                                             ^ Location                   ^                                                                                                                                                                                                                          ^
| Chidi	Asuzu     |                                                     | USA            |                                                                                                                                                                                                                          |
| Rebecca Baker     | CDISC                                                    | Austin, TX, USA            |                                                                                                                                                                                                                          |
| Ian	Braun         | Critical Path Institute                                  | Tucson, AZ, USA            |                                                                                                                                                                                                                          |
| Melissa Cook      | Essex Management                                         | Boston, MA, USA            | [[http://www.linkedin.com/in/mkcook|{{:wiki:linkedinicon.png?20}}]]                                                                                                                                                      |
| Diane	Corey       | Critical Path Institute                                  | Tucson, AZ, USA            |                                                                                                                                                                                                                          |
| Shital Desai     | Independent                                                   | USA            |                                                                                                                                                                                                                          |
| Kerry Goetz       | National Institute of Health; \\ National Eye Institute  | Bethesda, MD, USA          | [[https://www.linkedin.com/in/kerrygoetz/|{{:wiki:linkedinicon.png?20}}]]                                                                                                                                                
| Mike Hamidi       | Walmart Healthcare Research Institute                                                   | USA                        | [[https://www.linkedin.com/in/kamiar-mike-hamidi-0a908164/|{{:wiki:linkedinicon.png?20}}]]                                                                                                                               |
| Dan  Hartley     | Critical Path Institute                                                    | USA            |                                                                                                                                                                                                                          |
| Ying	Huang       |National Institute of Health                                       | USA            |                                                                                                                                                                                                                          |
| Asiyah Yu Lin     | National Institute of Health  | Bethesda, MD, USA |
| Zhen Lin *         | Robot Bacon                                       | Houston, TX, USA           | [[https://www.linkedin.com/in/zhen-lin/|{{:wiki:linkedinicon.png?20}}]], [[https://twitter.com/zhenLinPhDRN|{{:wiki:twittericon.png?20}}]]                                                                               |
| 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           |                                                                                                                                                                                                                          |
| Paul Orona     |                                                     | USA            |                                                                                                                                                                                                                          |
| Daniel Olson      | Critical Path Institute                                  | Tucson, AZ, USA            |                                                                                                                                                                                                                          |
| Katy Sadowski     | TrialSpark                                               | New York, NY, USA          |                                                                                                                                                                                                                          |
| Philip Solovyev   | Odysseus Data Services Inc.                              | Vilnius, Lithuania         | [[https://www.linkedin.com/in/filippsolovev|{{:wiki:linkedinicon.png?20}}]]                                                                                                                                              |
| Cynthia Sung      | OHDSI                                                    | Seattle, WA, USA           | [[https://www.linkedin.com/in/cynthia-sung-phd-fcp-ba01703/|{{:wiki:linkedinicon.png?20}}]]                                                                                                                              |
| Ramona Walls      | Critical Path Institute                                  | Tucson, AZ, USA            | [[https://www.linkedin.com/in/ramona-walls-41aa7599/|{{:wiki:linkedinicon.png?20}}]], [[https://twitter.com/Ramona_Walls|{{:wiki:twittericon.png?20}}]], [[https://github.com/ramonawalls|{{:wiki:githubicon.png?15}}]]  |
| 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  |                                                                                                                                                                                                                          |

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**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 | 
| Michael Kallfelz  | Odysseus Data Services Inc.                              | Berlin, Germany            | [[https://www.linkedin.com/in/michael-kallfelz/|{{:wiki:linkedinicon.png?20}}]]                                                                                                                                          |
| 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 | 
| Ariana Winder     | Javara Research                                                       | State College, Pennsylvania, USA        | [[https://www.linkedin.com/in/amwinder/|{{:wiki:linkedinicon.png?20}}]]                                                                                                                                                  |
| Stella Zhu      | Bill & Melinda Gates Medical Research Institute                            | Seattle, WA, USA|

* Past leads

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**Want to contribute to the group?** [[https://ohdsi.org/join-the-journey/|Opt-in here]]. \\
[[https://ohdsi.org/this-week-in-ohdsi/|Click here to catch up recent calls and job openings]]
~~NOTOC~~