projects:workgroups:clinicalstudy
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projects:workgroups:clinicalstudy [2023/02/12 19:47] zhen move inactive members |
projects:workgroups:clinicalstudy [2025/05/11 15:58] (current) mikehamidi |
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| **Status**:\\ | **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. \\ | + | - 2025: CTWG is providing new chapter content (Clinical Trial Data) for the upcoming Book of OHDSI update. |
| - | - 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). \\ | + | - 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.\\ | - 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> | ||
| Line 25: | Line 28: | ||
| 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]] | + | 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]] | ||
| ---- | ---- | ||
| ==== Meetings ==== | ==== Meetings ==== | ||
| - | {{:projects:workgroups:ct_wg_ohdsi2021fallsymp.png?direct&300|}} | ||
| - | **Spring 23 Schedule**: \\ | + | **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. \\ |
| - | Weekly rotating schedule on Fridays, 8AM PT/10AM CT/11AM ET/4PM UK/11PM CST;\\ | + | |
| - | and Fridays, 10AM PT/12AM CT/1PM ET/6PM UK/1AM CST;\\ | + | |
| - | on [[https://teams.microsoft.com/l/channel/19%3acc614694401a40b4b48668bd271cc9c0%40thread.tacv2/General?groupId=176311d3-ef0e-467c-bf6f-47c7f3aa82a0&tenantId=a30f0094-9120-4aab-ba4c-e5509023b2d5|Teams ]] \\ | + | |
| - | For example:\\ | + | *** Note on accessing Teams channel:**\\ |
| - | * Jan 27th: 11AM ET\\ | + | |
| - | * Feb 3rd: 1PM ET\\ | + | |
| - | * Feb 10th: 11AM ET\\ | + | |
| - | * Feb 17th: 1PM ET\\ | + | |
| - | + | ||
| - | *** 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\\ | ||
| + | * Join our WG here if you haven't: https://ohdsi.org/join-the-journey/. | ||
| ---- | ---- | ||
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| **WG co-leads**: | **WG co-leads**: | ||
| - | Mike Hamidi, Pfizer, US ([email protected]) and | + | Open Spot |
| - | Zhen Lin, Memorial Hermann TMC | Robot Bacon, US ([email protected]) | + | and |
| + | Kenneth Wilkins | ||
| + | **WG past leads**: | ||
| + | Mike Hamidi, Tom Walpole, Zhen Li, Sonia Araujo | ||
| **Active members**\\ | **Active members**\\ | ||
| - | ^ Name ^ Organization ^ Location ^ ^ | + | ^ Name ^ Organization ^ Location ^ ^ |
| - | | Rebecca Baker | CDISC | Austin, TX, USA | | | + | | Chidi Asuzu | | USA | | |
| - | | Ian Braun | Critical Path Institute | Tucson, AZ, USA | | + | | Rebecca Baker | CDISC | Austin, TX, USA | | |
| - | | Melissa Cook | Essex Management | Boston, MA, USA | [[http://www.linkedin.com/in/mkcook|{{:wiki:linkedinicon.png?20}}]] | | + | | Ian Braun | Critical Path Institute | Tucson, AZ, USA | | |
| - | | Diane Corey | Critical Path Institute | Tucson, AZ, USA | | + | | Melissa Cook | Essex Management | Boston, MA, USA | [[http://www.linkedin.com/in/mkcook|{{:wiki:linkedinicon.png?20}}]] | |
| - | | Kerry Goetz | National Institute of Health; \\ National Eye Institute | Bethesda, MD, USA | [[https://www.linkedin.com/in/kerrygoetz/|{{:wiki:linkedinicon.png?20}}]] | | + | | Diane Corey | Critical Path Institute | Tucson, AZ, USA | | |
| - | | Priya Gopal | Flatiron Health | New York, NY, USA | | | + | | Shital Desai | Independent | USA | | |
| - | | Mike Hamidi | Pfizer | USA | [[https://www.linkedin.com/in/kamiar-mike-hamidi-0a908164/|{{:wiki:linkedinicon.png?20}}]] | | + | | Kerry Goetz | National Institute of Health; \\ National Eye Institute | Bethesda, MD, USA | [[https://www.linkedin.com/in/kerrygoetz/|{{:wiki:linkedinicon.png?20}}]] |
| - | | Michael Kallfelz | Odysseus Data Services Inc. | Berlin, Germany | [[https://www.linkedin.com/in/michael-kallfelz/|{{:wiki:linkedinicon.png?20}}]] | | + | | Mike Hamidi | Walmart Healthcare Research Institute | USA | [[https://www.linkedin.com/in/kamiar-mike-hamidi-0a908164/|{{:wiki:linkedinicon.png?20}}]] | |
| - | | Asiyah Yu Lin | National Institute of Health; \\ National Center for Ontological Research | Bethesda, MD, USA | | | + | | Dan Hartley | Critical Path Institute | 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}}]] | | + | | Ying Huang |National Institute of Health | USA | | |
| - | | Terrence McHugh | Critical Path Institute | Tucson, AZ, USA | | + | | Asiyah Yu Lin | National Institute of Health | Bethesda, MD, USA | |
| - | | Daniel Olson | Critical Path Institute | Tucson, AZ, 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}}]] | |
| - | | Katy Sadowski | TrialSpark | New York, NY, USA | | | + | | Zhixin Lun | University of Colorado Anschutz Medical Campus | Aurora, CO, USA | | |
| - | | Philip Solovyev | Odysseus Data Services Inc. | St. Petersburg, Russia | | | + | | Terrence McHugh | Critical Path Institute | Tucson, AZ, USA | | |
| - | | Cynthia Sung | Bill & Melinda Gates Medical Research Institute | Seattle, WA, USA| | + | | Priya Meghrajani | Talosix | Seattle, WA, USA | | |
| - | | 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}}]] | | + | | Paul Orona | | USA | | |
| - | | Tom Walpole | Trials.ai | San Diego, CA, USA | | | + | | Daniel Olson | Critical Path Institute | Tucson, AZ, USA | | |
| - | | Kenneth Wilkins | National Institute of Health | Bethesda, MD, USA | | | + | | Katy Sadowski | TrialSpark | New York, NY, USA | | |
| - | | Qi Yang | IQVIA | Plymouth Meeting, PA, 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 | | | ||
| ---- | ---- | ||
| Line 93: | Line 97: | ||
| | Stephen Fortin | | | | | Stephen Fortin | | | | ||
| | Vojtech Huser | National Library of Medicine,\\ National Institutes of Health | Bethesda, MD, USA | | | 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 | | | Gregory Klebanov | Odysseus Data Services Inc. | Cambridge, MA, USA | | ||
| | Bess LeRoy | CDISC | Tucson, AZ, USA | | | Bess LeRoy | CDISC | Tucson, AZ, USA | | ||
| - | | James Liddil | M2Gen | Tampa, FL, USA | | + | | James Liddil | M2Gen | Tampa, FL, USA | |
| | Maxim Moinat | The Hyve | Utrecht, The Netherlands | | | Maxim Moinat | The Hyve | Utrecht, The Netherlands | | ||
| | Alexandra Orlova | Odysseus Data Services Inc. | Cambridge, MA, USA | | | Alexandra Orlova | Odysseus Data Services Inc. | Cambridge, MA, USA | | ||
| Line 103: | Line 108: | ||
| | Emma Vos | The Hyve | Utrecht, The Netherlands| | | Emma Vos | The Hyve | Utrecht, The Netherlands| | ||
| | Andrew Williams | Tufts Institute for Clinical Research \\ and Health Policy Studies | Boston, MA, USA | | | Andrew Williams | Tufts Institute for Clinical Research \\ and Health Policy Studies | Boston, MA, USA | | ||
| - | | Ariana Winder | nPhase, REDCap Cloud | Bellefonte, PA, USA | [[https://www.linkedin.com/in/amwinder/|{{:wiki:linkedinicon.png?20}}]] | | + | | 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| | | Stella Zhu | Bill & Melinda Gates Medical Research Institute | Seattle, WA, USA| | ||
projects/workgroups/clinicalstudy.1676231225.txt.gz · Last modified: 2023/02/12 19:47 by zhen
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