projects:workgroups:clinicalstudy
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projects:workgroups:clinicalstudy [2020/06/26 19:14] saraujo |
projects:workgroups:clinicalstudy [2024/01/15 15:59] (current) zhen [Meetings] |
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| - | ====== Clinical Trial WG ====== | + | ====== Clinical Trials Working Group ====== |
| <WRAP box justify round> | <WRAP box justify round> | ||
| - | **Objective:** Understand clinical trial use cases where the OHDSI platform & ecosystem can aid trials in any aspect, and assist in driving updates in OHDSI tools to support. This might be to represent data from interventional trial or observational study in OMOP CDM, might include enabling feasibility analysis, might include trial data collection, supporting biostatistics, or delivering real-world evidence to help trialists, or other. | + | **Objective**: To allow adequate representation of clinical trial data in OMOP. |
| - | **Project Lead:** Sonia Araujo, IQVIA London (sonia.araujo@iqvia.com) | + | **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. |
| - | **Members:** | + | **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. |
| - | * Andrew Williams, PhD, Tufts | + | |
| - | * Greg Klebanov, MS, Odysseus | + | |
| - | * Rupa Makadia, PhD, Janssen | + | |
| - | * Vojtech Huser, PhD, NIH | + | |
| - | * Chris Roeder, MS, Colorado | + | |
| - | * Thomas Falconer, MS, Columbia | + | |
| - | * Josh Ransom, PhD, Medidata | + | |
| - | * Ryan Li, Columbia | + | |
| - | * Ana Heredia, GMV | + | |
| - | * Ayesha Kang, Deloitte | + | |
| - | * Kees van Bochove, MS, The Hyve | + | |
| - | * Maxim Moinat, MS, The Hyve | + | |
| - | * Sonia Araujo, PhD, IQVIA | + | |
| - | * Jill Hardin, PhD, Janssen | + | |
| - | * Shawn Dolley, MBA consultant to Gates Foundation | + | |
| - | **Start Date:** 2019 (this started as 'Clinical Study' working group in 2016 and was dormant) | + | **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.\\ | ||
| + | </WRAP> | ||
| - | **Repository:** | ||
| - | * https://github.com/vojtechhuser/project/tree/master/sdtm-omop | ||
| - | * {{:projects:workgroups:using-real-world-evidence-to-optimize-clinical-trials_2018-shyftanalytics.pdf|White Paper: Using RWE in Trials by SHYFT Analytics}} | ||
| - | * {{:projects:workgroups:SHYFT-OHDSI-POSTER.pdf|Poster: Leveraging the OMOP CDMv5 for CDISC SDTM RCT Data}} | ||
| - | * {{https://www.shyftanalytics.com/webinars/7-ways-to-compress-your-clinical-trial/|Webinar: 7 Ways to Compress Your Clinical Trial (registration required)}} | ||
| - | * {{:projects:workgroups:20190423-clinical-trials-and-rwd.pptx|All Identified Use Cases Joining Clinical Trial Data with Real World Data}} | ||
| - | * {{:projects:workgroups:the_hyve_ohdsi_clinical_trials_wg_presentation_20190412.pdf|The Hyve presentation on clinical trials in OMOP 20190412}} | ||
| + | ==== Important Links ==== | ||
| - | </WRAP> | + | Conventions proposal submitted to OHDSI\\ |
| + | https://github.com/OHDSI/CommonDataModel/issues/358 | ||
| + | Group GitHub repository\\ | ||
| + | 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|}} | |
| - | **Latest meeting recordings:** | + | |
| - | * 26 Jun 2020: https://youtu.be/bBW8Znz2hQI (unlisted) | + | **Spring 24 Schedule**: \\ |
| - | * 22 May 2020: https://youtu.be/F7LLaGKwa-I (unlisted) | + | Bi-weekly on Fridays, 8:30AM PT/10:30AM CT/11:30AM ET/4:30PM UK/11:30PM CST, from Jan. 19th;\\ |
| - | * 15 May 2020: https://youtu.be/u_9_AHs6bdc (unlisted) | + | |
| - | * 01 May 2020: https://youtu.be/cRvHcwaO-yg (unlisted) | + | *** Note on accessing Teams channel above:**\\ |
| - | * 03 Apr 2020: https://youtu.be/51nEFDCSH0g (unlisted) | + | * 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\\ |
| - | * 20 Mar 2020: https://youtu.be/ISWQpqGH_Hg (unlisted) | + | * Alternatively, select the "web app" button in the link above for accessing meetings on your browser\\ |
| - | * 06 Mar 2020: https://youtu.be/1UyrBVa28aU (partial) (unlisted) | + | |
| - | * 07 Feb 2020: https://youtu.be/95vD4A12gWE (unlisted) | + | ---- |
| - | * 10 Jan 2020: https://youtu.be/_7billAOg60 (unlisted) | + | |
| - | * 06 Dec 2019: presentations from the Hyve, Medidata and Odysseus, https://youtu.be/Fc9OHg8qCq0 (unlisted) | + | ==== Membership ==== |
| + | |||
| + | **WG co-leads**: | ||
| + | Mike Hamidi, Pfizer, US (Kamiar.Hamidi@pfizer.com), | ||
| + | Tom Walpole, ZS Associates, US, | ||
| + | and | ||
| + | Zhen Lin, Memorial Hermann TMC | Robot Bacon, US (Zhen.Lin@ohdsi.org) | ||
| + | |||
| + | |||
| + | **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 | | USA | | | ||
| + | | Kerry Goetz | National Institute of Health; \\ National Eye Institute | Bethesda, MD, USA | [[https://www.linkedin.com/in/kerrygoetz/|{{:wiki:linkedinicon.png?20}}]] | | ||
| + | | Priya Gopal | Flatiron Health | New York, NY, USA | | | ||
| + | | Mike Hamidi | Pfizer | USA | [[https://www.linkedin.com/in/kamiar-mike-hamidi-0a908164/|{{:wiki:linkedinicon.png?20}}]] | | ||
| + | | 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 | | | ||
| + | |||
| + | ---- | ||
| + | |||
| + | **Other members**\\ | ||
| - | **Logs of past meetings:** | + | ^ Name ^ Organization ^ Location ^ |
| - | * {{:projects:workgroups:20190208_ohdsi_ct_wg.docx|Feb 8 2019 Log}} | + | | Eldar Allakhverdiiev | Odysseus Data Services Inc. | Cambridge, MA, USA| ^ |
| - | * {{:projects:workgroups:20190301_2nd_meeting_log_-_march_1_2019_-_ohdsi_ct_wg.docx|March 1 2019 Log}} | + | | Sonia Araujo * | IQVIA | London, UK | |
| - | * Recording of Mar 15 2019 meeting, unlisted to the public: https://youtu.be/6Wh2BTB6DXU | + | | Junn Bautista | Genentech | South San Francisco, CA, USA | | |
| - | * {{:projects:workgroups:20190426 Meeting 4-CDISC-to-OHDSI-Odysseus.docx|Apr 26 2019 Log}} | + | | Elise Berliner | | | |
| - | * Recording of Apr 26 2019 meeting, unlisted to the public: Odysseus & Medidata Presentation on Clin Trials to OMOP Common Data Model: https://youtu.be/R8dnOZA6ODE | + | | Ted Bebi | Medidata | Boston, MA, USA | |
| - | * Recording of May 10 2019 meeting, unlisted to the public: https://youtu.be/XIuSnsMov8U | + | | Lina Clover | SAS | Raleigh-Durham, NC, USA | |
| - | * Unlisted Youtube recording of CDISC's presentation to our group: https://youtu.be/Wal6ZfNtA58 | + | | 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| | ||
| - | **Old/ Archive** | + | * Past leads |
| - | * http://forums.ohdsi.org/t/omop-cdm-and-clinical-trials/2109 | + | |
| - | * http://forums.ohdsi.org/t/requirements-for-clinical-study-trial-data-in-ohdsi/3202 | + | |
| - | * http://www.ohdsi.org/web/wiki/doku.php?id=documentation:next_cdm:clinical_trial | + | |
| - | **Schedule**: Biweekly calls on Fridays, 3pm UK time (10am EST) | + | ---- |
| - | **Want to contribute** to the group and participate in group calls? Email sonia.araujo@iqvia.com | + | **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~~ | ||
projects/workgroups/clinicalstudy.1593198871.txt.gz · Last modified: 2020/06/26 19:14 by saraujo
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