Innovative Medicines Initiative WEB-RADR 2 · 2020. 6. 19. · Provide feedback on the technical...
Transcript of Innovative Medicines Initiative WEB-RADR 2 · 2020. 6. 19. · Provide feedback on the technical...
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Innovative Medicines InitiativeWEB-RADR 2
Webinar 2: terminology mappings
@WEBRADR #WEBRADR2020
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David Lewis, Novartis
Phil Tregunno, MHRA
@WEBRADR #WEBRADR2020
Welcome
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WEB-RADR
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Vision
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#WEBRADR2020
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Aims of the webinar
• WEB-RADR 2 outputs and achievementsShare
• Enhanced data exchange through terminology interoperabilityInspire
• Further discussion and collaborationInitiate
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Webinar 2: terminology mappings
Jane Millar, SNOMED International
Speakers
Patrick Revelle, MedDRA MSSO
Judy Harrison, MedDRA MSSO
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Judy Harrison, MedDRA MSSO
Jane Millar, SNOMED International
Patrick Revelle, MedDRA MSSO
@WEBRADR #WEBRADR2020
Work Package 4: Terminology Mapping And Maintenance
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Terminology interoperability
• Longstanding need to exchange data between Electronic Health Record systems and the drug regulatory space based on standardised terminologies in order to support better public health information and patient safety
• Aim to achieve interoperability through maps between SNOMED CT (healthcare systems) and MedDRA (regulatory arena)
Facilitates conversion of SNOMED CT-encoded EHR data to MedDRA as a source for adverse event reporting
Allows MedDRA-coded data on product labels to be accessible in clinical decision support systems using the MedDRA to SNOMED CT map
• First time that the terminology owners, ICH and SNOMED International, have collaborated to produce endorsed standardised maps
• Sustainability of the work beyond the project by continued maintenance of the maps is a key aspect
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Work Package 4
WP 4 - “Terminology Mapping and Maintenance”
Co-leads: Patrick Revelle (MSSO) and Jane Millar (SNOMED International)
Aims:
• Develop bi-directional independent maps between SNOMED CT and MedDRA based on a priority set of MedDRA content
• Develop ownership, maintenance, licensing and distribution arrangements between ICH and SNOMED International to enable sustainable implementation beyond the end of the project
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Source data for mapping
• List of Terms to Map (Bi-directional)
7,349 MedDRA LLTs
Derived from EMA and MHRA, UK reported terms
Included adverse events, medical history, and indications
All 27 SOCs represented
Included terms from EMA’s Designated Medical Event (DME) list
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Mapping teams and process
• Dual independent mapping
• Quality assurance
• Knowledge of SNOMED CT and MedDRA required
• Team 1• Sandra Fielder (AbbVie) - Mapper
• Martin Menke (CSL Behring) – Mapper
• Sophie Reeve, Tamara Darwiche (MHRA) – Quality Assurance
• Team 2• Isabel Lázaro Salcedo (AEMPS) - Mapper
• Belen Castro (AEMPS) – Mapper
• Kine Toure Lam (AEMPS) – Mapper
• Debbra Scotti (Pfizer) – Quality Assurance
• Maintenance Organization Quality Assurance• SNOMED International – Donna Morgan, Krista Lilly
• MSSO – Ali Awan, Amanda Saunders, Judy Harrison
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Map deliverables
• Two independent maps
MedDRA to SNOMED CT map (6,374 LLTs mapped to SNOMED CT Fully Specified Names (FSN))
SNOMED CT to MedDRA map (3,684 FSNs mapped to LLTs)
Spreadsheet and RF2 formats
• Mapping conventions
Developed and revised through project
Available to users to understand how maps were created and to interpret results obtained
To be used for ongoing maintenance and updating
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Map examples
• MedDRA to SNOMED CT
• SNOMED CT to MedDRA
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Post-project steps
15
Nov 2019Bi-directional Term Mapping Complete
Feb 2020IMI Project Complete
March 2020Alpha Test Period Begins
- Scope includes format and content - Test Protocol Developed
- Regulatory, Industry, Vendor, Clinical Users, and Member country Testers
Identified
Sept 2020Alpha Test Period Ends
April 2021Production Version of the Maps
made available to licensed SNOMED/MedDRA Users
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Alpha test/review of maps
• Alpha test/review period - April to September 2020
• Based on MedDRA version 21.1 (released September 2018) and SNOMED CT January 2019 International edition
• Purpose:Provide feedback on the quality and accuracy of the content of the maps
Provide feedback on the technical representation in the SNOMED CT RF2 version.
• Participants from stakeholder communities of both MedDRA and SNOMED InternationalParticipants must be a licensee of either MedDRA or SNOMED CT (or both)
• Participants are Regulators, Industry, Vendors, Researchers, Clinicians, Informaticians/Terminologists, SNOMED International Member Countries
• This period is intended to signal to both SNOMED CT and MedDRA communities and wider stakeholders the availability of these maps, which are new products to both organisations.
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Alpha test/review of maps
• Participants are invited to complete a protocol questionnaire or provide ad hoc feedback
• In providing feedback, respondees are asked to provide details of the Use Cases they have applied when reviewing the maps, details of any data that has been used in comparison and also any specific areas of the Maps which are relevant
• The mapping conventions document has been shared so that reviewers can comment on how they supported the understanding of how the maps were created.
• As well as review of the Maps, respondees are asked to compare them to any similar maps they might have access to, though taking into account the issue of versioning etc.
• Comments on format and technical issues are invited, depending on which version they have used for review. Details of any software that have been applied are requested.
Any queries on this topic, contact either SNOMED International at [email protected] or [email protected].
Alpha test/review protocol
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Plans after alpha test
• Analyse Alpha Test/Review Feedback – October 2020
Consider content and format changes to the maps
Note that scope of maps remain the same
• Update maps to SNOMED CT International Edition January 2021 and MedDRA September 2020 – January/February 2021
• Extend the scope of the maps to include relevant COVID-19 terms
SNOMED CT and MedDRA both added COVID-19 terms during this period
• Complete the agreement between ICH and SNOMED International for maintenance of Maps
Sustainability of the maps beyond the WEB-RADR 2 project
Manage any further requirements, ensuring the maps meet the needs of users
• Production release of the 2 Maps - April 2021
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Mapping maintenance
• Process developed during initial mapping within WEB-RADR 2 project
Consider content and format changes to the mappings
• Will support proposed additions and changes
SNOMED CT and MedDRA users will be able to submit change requests
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Mapping maintenance (continued)
• Access and Distribution
Free to SNOMED CT and MedDRA users
RF2 for distribution to SNOMED CT users
Spreadsheets currently for distribution to MedDRA users
• SNOMED International and MSSO will form a project team to maintain the maps
Key is to sustain the quality of the maps as user needs evolve and as both terminologies develop
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@WEBRADR #WEBRADR2020
Question and answer
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Phil Tregunno, MHRA
@WEBRADR #WEBRADR2020
Concluding remarks
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Next steps
@WEBRADR
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Thank you for joining
Contact email: [email protected]
WEB-RADR website: https://web-radr.eu/
Webinar recording available on WEB-RADR website Events page:
https://web-radr.eu/events/
@WEBRADR
#WEBRADR2020
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Innovative Medicines InitiativeWEB-RADR 2
Stakeholder-focused webinars
@WEBRADR #WEBRADR2020