projects:workgroups:clinicalstudy
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projects:workgroups:clinicalstudy [2021/09/04 11:38] zhen |
projects:workgroups:clinicalstudy [2024/01/15 15:59] (current) zhen [Meetings] |
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| **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. | **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 are built on OMOP CDM v6 and the Oncology extension, with v5.3.1 backward compatibility. | + | **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**:\\ | **Status**:\\ | ||
| - | - Proposals submitted to the OHDSI community in July 2020.\\ | + | - 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. \\ |
| - | - Currently applying our proposed conventions to the PHUSE database (a synthetic SDTM database). | + | - 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.\\ | ||
| </WRAP> | </WRAP> | ||
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| https://github.com/OHDSI/ClinicalTrialsWGETL | https://github.com/OHDSI/ClinicalTrialsWGETL | ||
| + | Recent WG Updates: [[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]] | ||
| ---- | ---- | ||
| ==== Meetings ==== | ==== Meetings ==== | ||
| + | {{:projects:workgroups:ct_wg_ohdsi2021fallsymp.png?direct&300|}} | ||
| - | **Schedule**: | + | **Spring 24 Schedule**: \\ |
| - | Biweekly calls on Fridays, 7:30AM PT/9:30AM CT/10:30AM ET/3:30PM UK time on Teams [[https://teams.microsoft.com/l/channel/19%3acc614694401a40b4b48668bd271cc9c0%40thread.tacv2/General?groupId=176311d3-ef0e-467c-bf6f-47c7f3aa82a0&tenantId=a30f0094-9120-4aab-ba4c-e5509023b2d5|here]] | + | Bi-weekly on Fridays, 8:30AM PT/10:30AM CT/11:30AM ET/4:30PM UK/11:30PM CST, from Jan. 19th;\\ |
| - | //**Note on accessing Teams channel above:**\\ | + | *** 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\\ | * 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// | + | * Alternatively, select the "web app" button in the link above for accessing meetings on your browser\\ |
| ---- | ---- | ||
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| **WG co-leads**: | **WG co-leads**: | ||
| - | [[https://www.linkedin.com/in/kamiar-mike-hamidi-0a908164/|Mike Hamidi]], Pfizer, US (Kamiar.Hamidi@pfizer.com) | + | Mike Hamidi, Pfizer, US (Kamiar.Hamidi@pfizer.com), |
| - | [[https://www.linkedin.com/in/zhen-lin/|Zhen Lin]], Robot Bacon, US (Zhen.Lin@ohdsi.org) | + | Tom Walpole, ZS Associates, US, |
| + | and | ||
| + | Zhen Lin, Memorial Hermann TMC | Robot Bacon, US (Zhen.Lin@ohdsi.org) | ||
| **Active members**\\ | **Active members**\\ | ||
| - | ^ Name ^ Organization ^ Location ^ ^ | + | ^ Name ^ Organization ^ Location ^ ^ |
| - | | Rebecca Baker | CDISC | Austin, Texas, USA | | | + | | Chidi Asuzu | | USA | | |
| - | | Mike Hamidi | Pfizer | USA | [[https://www.linkedin.com/in/kamiar-mike-hamidi-0a908164/|L]] | | + | | Rebecca Baker | CDISC | Austin, TX, USA | | |
| - | | Michael Kallfelz | Odysseus Data Services Inc. | Cambridge, MA, USA | | + | | Ian Braun | Critical Path Institute | Tucson, AZ, USA | | |
| - | | Zhen Lin | Robot Bacon | Houston, TX, USA | [[https://www.linkedin.com/in/zhen-lin/|L]], [[https://twitter.com/zhenLinPhDRN|T]] | | + | | Melissa Cook | Essex Management | Boston, MA, USA | [[http://www.linkedin.com/in/mkcook|{{:wiki:linkedinicon.png?20}}]] | |
| - | | Katy Sadowski | TrialSpark | New York, NY, USA | | | + | | Diane Corey | Critical Path Institute | Tucson, AZ, USA | | |
| - | | Philip Solovyev | Odysseus Data Services Inc. | Cambridge, MA, USA | | | + | | Shital Desai | | USA | | |
| - | | Anthony Sunjaya | The George Institute for Global Health, UNSW Sydney | Sydney, NSW, Australia | | | + | | Kerry Goetz | National Institute of Health; \\ National Eye Institute | Bethesda, MD, USA | [[https://www.linkedin.com/in/kerrygoetz/|{{:wiki:linkedinicon.png?20}}]] | |
| - | | Tom Walpole | Trials.ai | San Diego, CA, USA | | + | | Priya Gopal | Flatiron Health | New York, NY, USA | | |
| - | | Ariana Winder | REDCap Cloud | Bellefonte, PA, USA | [[https://www.linkedin.com/in/amwinder/|L]] | | + | | Mike Hamidi | Pfizer | USA | [[https://www.linkedin.com/in/kamiar-mike-hamidi-0a908164/|{{:wiki:linkedinicon.png?20}}]] | |
| - | | Qi Yang | IQVIA | Plymouth Meeting, PA, USA | | | + | | Dan Hartley | | USA | | |
| + | | Ying Huang |National Institute of Health | USA | | | ||
| + | | Asiyah Yu Lin | National Institute of Health | Bethesda, MD, USA | | ||
| + | | Zhen Lin | MH-TMC/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 | | | ||
| + | | Pam Nesbitt | | 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**\\ | **Other members**\\ | ||
| - | ^ Name ^ Organization ^ Location | + | ^ Name ^ Organization ^ Location ^ |
| | Eldar Allakhverdiiev | Odysseus Data Services Inc. | Cambridge, MA, USA| ^ | | Eldar Allakhverdiiev | Odysseus Data Services Inc. | Cambridge, MA, USA| ^ | ||
| - | | Sonia Araujo * | IQVIA | London, UK | | + | | Sonia Araujo * | IQVIA | London, UK | |
| - | | Ted Bebi | Medidata | Boston, MA, USA | | + | | Junn Bautista | Genentech | South San Francisco, CA, USA | | |
| - | | Lina Clover | SAS | Raleigh-Durham, NC, USA | | + | | Elise Berliner | | | |
| - | | Alexander Davydov | Odysseus Data Services Inc. | Cambridge, MA, USA | | + | | Ted Bebi | Medidata | Boston, MA, USA | |
| - | | Shawn Dolley | Open Global Health | Arlington, Virginia, USA | | + | | Lina Clover | SAS | Raleigh-Durham, NC, USA | |
| - | | Rhonda Facile | CDISC | Austin, Texas, USA | | + | | Alexander Davydov | Odysseus Data Services Inc. | Cambridge, MA, USA | |
| - | | Vojtech Huser | National Library of Medicine, National Institutes of Health | Bethesda, MD, USA | | + | | Shawn Dolley | Open Global Health | Arlington, Virginia, USA | |
| - | | Gregory Klebanov | Odysseus Data Services Inc. | Cambridge, MA, USA | | + | | Rhonda Facile | CDISC | Austin, Texas, USA | |
| - | | Bess LeRoy | CDISC | Tucson, AZ, USA | | + | | Stephen Fortin | | | |
| - | | James Liddil | M2Gen | Tampa, FL, USA | | + | | Vojtech Huser | National Library of Medicine,\\ National Institutes of Health | Bethesda, MD, USA | |
| - | | Asiyah Yu Lin | National Institute of Health | Bethesda, Maryland, USA | | + | | Michael Kallfelz | Odysseus Data Services Inc. | Berlin, Germany | [[https://www.linkedin.com/in/michael-kallfelz/|{{:wiki:linkedinicon.png?20}}]] | |
| - | | Maxim Moinat | The Hyve | Utrecht, The Netherlands | | + | | Gregory Klebanov | Odysseus Data Services Inc. | Cambridge, MA, USA | |
| - | | Alexandra Orlova | Odysseus Data Services Inc. | Cambridge, MA, USA | | + | | Bess LeRoy | CDISC | Tucson, AZ, USA | |
| - | | Joshua F. Ransom | BEKHealth Inc | Wayland, MA, USA | | + | | James Liddil | M2Gen | Tampa, FL, USA | |
| - | | Chris Roeder | School of Medicine, University of Colorado | CO, USA | | + | | Maxim Moinat | The Hyve | Utrecht, The Netherlands | |
| - | | Cynthia Sung| Bill & Melinda Gates Medical Research Institute | Seattle, WA, USA| | + | | Alexandra Orlova | Odysseus Data Services Inc. | Cambridge, MA, USA | |
| - | | Emma Vos | The Hyve | Utrecht, The Netherlands| | + | | Joshua F. Ransom | BEKHealth Inc | Wayland, MA, USA | |
| - | | Andrew Williams | Tufts Institute for Clinical Research and Health Policy Studies | Boston, 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 | * Past leads | ||
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| ---- | ---- | ||
| - | **Want to contribute to the group?** [[https://ohdsi.org/join-the-journey/|Opt-in here]], or email Mike and/or Zhen. | + | **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~~ | ~~NOTOC~~ | ||
projects/workgroups/clinicalstudy.1630755527.txt.gz · Last modified: 2021/09/04 11:38 by zhen
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