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Upcoming Blue Ribbon Panel

Blue Ribbon Panels
BRP 8 Scope of MedDRA - 29 April 2014
Purpose: To discuss how the scope of MedDRA should be defined in its role as an international medical and regulatory terminology and to address issues pertaining to the possible expansion of the terminology into new topic areas. Such issues include how to establish general criteria when considering potential areas for expansion (e.g., manufacturing product quality concepts and additional device-related concepts) and where new topic areas can be placed in MedDRA.
Documentation: BRP background document BRP presentation BRP recommendations BRP 8 recommendations and MedDRA Board outcomes
BRP 7 Proposed Revisions to the Neoplasm SOC - 12 April 2011
Purpose: Based on suggestions from a MedDRA user at the US National Cancer Institute (NCI), the MSSO convened BRP7 to discuss possible delinking of “cyst” terms from SOC Neoplasms benign, malignant and unspecified (incl cysts and polyps), improvement of the specificity of tumour terms at the PT level, and improvement/update of the classification of tumours in MedDRA.
Outcome: The MSSO first studied the impact that the Panel proposals might have on already coded data and new data if their recommendations were to be implemented. The proposed changes were also posted for general user comment. After review of the feedback and analysis, the Management Board endorsed all of the Panel’s recommendations except the proposal to demote all “stage” PTs to LLT level (this may be reconsidered at a future date). The changes were implemented in MedDRA Version 16.0 (March 2013).
Documentation: Orientation to the topic BRP presentation BRP recommendations and MedDRA Board outcome
BRP 6 Extent of MedDRA Versioning and Feasibility of an Annual MedDRA Release - 13 May 2009
Purpose: To discuss an MSSO concept paper regarding the extent of MedDRA versioning (i.e., what an organisation does to implement the latest version of MedDRA) and to discuss the feasibility of changing from a twice to once annual MedDRA release frequency.
Outcome: The Panel's recommendations were reviewed and endorsed by the MedDRA Management Board. The MedDRA Term Selection Points to Consider document was amended as recommended. The Panel’s specific recommendation of “MSSO to consider developing a software tool to help subscribers assess the impact of a new version on their data to facilitate the task of upversioning” led to the development of the free online MedDRA Version Analysis Tool (MVAT) which became available to MedDRA subscribers in September 2012.
Documentation: Extent of versioning: background and questions for Panel Extent of versioning: MSSO draft recommendation Frequency of MedDRA release: background and questions for Panel BRP presentation BRP 6 recommendations BRP recommendation and MedDRA Board outcome
BRP 5 Proposed Terminology Changes to Facilitate the Analysis of MedDRA-Coded Data - 16 November 2006
Purpose: In response to subscribers’ requests, the MSSO conducted a feasibility study in 2005 on MedDRA hierarchy structure modifications to improve its support of statistical analysis and reporting. The existing MedDRA rules and conventions, such as primary SOC allocation, were reviewed in this context. The MSSO originally drafted 7 proposals, 4 of which were referred to this BRP for further discussion. These 4 proposals were: Review “NEC” HLTs and HLGTs Explore alternative namings for clearer indication of their content Review large sized HLT groupings for possible reduction of the number of subordinate PTs Allow multiaxiality of SOC Investigations Allow multiaxiality of SOC Social circumstances Eliminate multiaxial HLTs (i.e., an HLT that is linked to more than one SOC) in cumulative data outputs when only the primary paths are displayed
Outcome: Regarding the “NEC” HLTs, the Management Board endorsed this recommendation, and these were addressed over subsequent versions of MedDRA. The Panel's recommendation of conducting a pilot study on implementing concept attribute relationships in MedDRA terminology was approved by the MedDRA Management Board. The MSSO conducted the pilot program (see below). For detailed information, please refer to the “Concept Attribute Pilot Plan” document. In the pilot study, the MSSO analysed the cost and level of effort for the de novo approach to establish diagnosis-test relationships, compared to those by exploiting existing relationships in National Library of Medicine's Unified Medical Language System (UMLS). In conclusion, both approaches are cost- and resource-intensive. Therefore, concept attributes for MedDRA are not feasible at present. Regarding the Panel’s recommendations for SOC Social circumstances, these were endorsed by the Board and implemented in MedDRA Version 10.1. Finally, regarding the Panel’s recommendation for multiaxial HLTs in cumulative data output, the Board also endorsed these recommendations which were implemented in MedDRA Version 11.0.
Documentation: BRP Concept Paper Drug Information Journal Article BRP presentation BRP 5 summary Concept Attribute Pilot Plan BRP recommendation and MedDRA Board outcome
BRP 4 CTCAE (CommonTerminology Criteria for Adverse Events) to MedDRA Mapping - 6 April 2006
Purpose: This BRP meeting was intended to address the following questions: Does the updated mapping of CTCAE base terms with a proposed six month maintenance schedule meet the needs of MedDRA users? Is there a need for a standardised mapping of CTCAE grades to MedDRA? If yes, what are the options for mapping? If no, what guidance should be provided for users?
Outcome: After review of the recommendations by the MedDRA Management Board, a cooperative working group was formed by stakeholders involved with both terminologies. The ultimate product of these discussions was a revision of CTCAE (CTCAE Vervion 4.0 released in May 2009) in which the CTCAE adverse event terms were reconciled to MedDRA LLTs while still supporting a revised grading system.
Documentation: CTCAE to MedDRA Mapping Concept Paper BRP presentation BRP 4 summary BRP recommendation and MedDRA Board outcome CTCAE working group teleconference (8 July 2008) CTCAE Version 3.0 vocabulary standards review (11 July 2008) CTCAE Version 3.0 revision project (11 July 2008) CTCAE Version 4.0 is posted on the CTEP website http://evs.nci.nih.gov/ftp1/CTCAE/About.html
BRP 3 MedDRA and Product Labelling: Best Practices - 16 March 2005
Purpose: The purpose of this BRP was to consider a set of general recommendations on how MedDRA-coded data should be used in biopharmaceutical product labelling. These recommendations were to take into account the multiple purposes of product labelling and the characteristics of MedDRA.
Outcome: The MedDRA Management Board, at their meeting in May 2005, discussed the BRP3 recommendations on MedDRA and product labelling. To address the needs of subscribers and for further clarification of this complex issue, the Management Board decided to solicit input from at least one other MedDRA expert organisation. Ultimately, it was concluded that the development of MedDRA Labelling Entities (MLEs) would not go forward.
Documentation: MedDRA and product labelling: "Best practices" recommendations Presentation: Can MedDRA be used for Labeling? Should it? Presentation: MedDRA and product labelling: Best ractices BRP 3 summary BRP recommendation and MedDRA Board outcome
BRP 2 MedDRA Modifiers - 18 June 2004
Purpose: The Panel met to consider potential options for accommodating requests for and uses of “modified” MedDRA concepts (e.g., terms for conditions that are “aggravated”, “acute”, “post-operative”). The core of the MSSO’s proposal included the use of a “base” term (e.g., confusion) paired with a “modifier” (e.g., acute). A list of “modifier” terms would be maintained along with “base” terms. The MSSO’s proposal included a change to MedDRA files with the potential for significant impact on users and their systems (e.g., E2B). The potential benefits and risks of this approach were outlined in a background/proposal document.
Outcome: The MedDRA Management Board endorsed the Panel’s recommended approach. After collecting feedback on a set of posted proposed modified terms, the MSSO added the terms to MedDRA Version 9.1.
Documentation: Background document BRP recommendation and MedDRA Board outcome
BRP 1 Scope and Specificity of MedDRA - 15 May 2003
Purpose: The purpose of this BRP was to provide the MedDRA Management Board with information to support the Board’s oversight and policy formation regarding MedDRA. At this particular meeting, the BRP was asked to review, discuss and make recommendations on MedDRA’s general scope and level of specificity.
Outcome:The recommendations were endorsed by the MedDRA Management Board and were implemented by the MSSO during MedDRA Version 7.0.
Documentation Background document BRP recommendation and MedDRA Board outcome

Blue Ribbon Panels

BRP 8 Scope of MedDRA - 29 April 2014

Purpose: To discuss how the scope of MedDRA should be defined in its role as an international medical and regulatory terminology and to address issues pertaining to the possible expansion of the terminology into new topic areas. Such issues include how to establish general criteria when considering potential areas for expansion (e.g., manufacturing product quality concepts and additional device-related concepts) and where new topic areas can be placed in MedDRA.

Documentation:

BRP 7 Proposed Revisions to the Neoplasm SOC - 12 April 2011

Purpose: Based on suggestions from a MedDRA user at the US National Cancer Institute (NCI), the MSSO convened BRP7 to discuss possible delinking of “cyst” terms from SOC Neoplasms benign, malignant and unspecified (incl cysts and polyps), improvement of the specificity of tumour terms at the PT level, and improvement/update of the classification of tumours in MedDRA.

Outcome: The MSSO first studied the impact that the Panel proposals might have on already coded data and new data if their recommendations were to be implemented. The proposed changes were also posted for general user comment. After review of the feedback and analysis, the Management Board endorsed all of the Panel’s recommendations except the proposal to demote all “stage” PTs to LLT level (this may be reconsidered at a future date). The changes were implemented in MedDRA Version 16.0 (March 2013).

Documentation:

BRP 6 Extent of MedDRA Versioning and Feasibility of an Annual MedDRA Release - 13 May 2009

Purpose: To discuss an MSSO concept paper regarding the extent of MedDRA versioning (i.e., what an organisation does to implement the latest version of MedDRA) and to discuss the feasibility of changing from a twice to once annual MedDRA release frequency.

Outcome: The Panel's recommendations were reviewed and endorsed by the MedDRA Management Board. The MedDRA Term Selection Points to Consider document was amended as recommended. The Panel’s specific recommendation of “MSSO to consider developing a software tool to help subscribers assess the impact of a new version on their data to facilitate the task of upversioning” led to the development of the free online MedDRA Version Analysis Tool (MVAT) which became available to MedDRA subscribers in September 2012.

Documentation:

BRP 5 Proposed Terminology Changes to Facilitate the Analysis of MedDRA-Coded Data - 16 November 2006

Purpose: In response to subscribers’ requests, the MSSO conducted a feasibility study in 2005 on MedDRA hierarchy structure modifications to improve its support of statistical analysis and reporting. The existing MedDRA rules and conventions, such as primary SOC allocation, were reviewed in this context.

The MSSO originally drafted 7 proposals, 4 of which were referred to this BRP for further discussion. These 4 proposals were:

Review “NEC” HLTs and HLGTs
- Explore alternative namings for clearer indication of their content
- Review large sized HLT groupings for possible reduction of the number of subordinate PTs
Allow multiaxiality of SOC Investigations
Allow multiaxiality of SOC Social circumstances
Eliminate multiaxial HLTs (i.e., an HLT that is linked to more than one SOC) in cumulative data outputs when only the primary paths are displayed

Outcome: Regarding the “NEC” HLTs, the Management Board endorsed this recommendation, and these were addressed over subsequent versions of MedDRA.

The Panel's recommendation of conducting a pilot study on implementing concept attribute relationships in MedDRA terminology was approved by the MedDRA Management Board. The MSSO conducted the pilot program (see below). For detailed information, please refer to the “Concept Attribute Pilot Plan” document.

In the pilot study, the MSSO analysed the cost and level of effort for the de novo approach to establish diagnosis-test relationships, compared to those by exploiting existing relationships in National Library of Medicine's Unified Medical Language System (UMLS). In conclusion, both approaches are cost- and resource-intensive. Therefore, concept attributes for MedDRA are not feasible at present.

Regarding the Panel’s recommendations for SOC Social circumstances, these were endorsed by the Board and implemented in MedDRA Version 10.1.

Finally, regarding the Panel’s recommendation for multiaxial HLTs in cumulative data output, the Board also endorsed these recommendations which were implemented in MedDRA Version 11.0.

Documentation:

BRP 4 CTCAE (CommonTerminology Criteria for Adverse Events) to MedDRA Mapping - 6 April 2006

Purpose: This BRP meeting was intended to address the following questions:

Does the updated mapping of CTCAE base terms with a proposed six month maintenance schedule meet the needs of MedDRA users?
Is there a need for a standardised mapping of CTCAE grades to MedDRA?
- If yes, what are the options for mapping?
- If no, what guidance should be provided for users?

Outcome: After review of the recommendations by the MedDRA Management Board, a cooperative working group was formed by stakeholders involved with both terminologies. The ultimate product of these discussions was a revision of CTCAE (CTCAE Vervion 4.0 released in May 2009) in which the CTCAE adverse event terms were reconciled to MedDRA LLTs while still supporting a revised grading system.

Documentation:

CTCAE to MedDRA Mapping Concept Paper
BRP presentation
BRP 4 summary
BRP recommendation and MedDRA Board outcome
CTCAE working group teleconference (8 July 2008)
CTCAE Version 3.0 vocabulary standards review (11 July 2008)
CTCAE Version 3.0 revision project (11 July 2008)
CTCAE Version 4.0 is posted on the CTEP website
http://evs.nci.nih.gov/ftp1/CTCAE/About.html

BRP 3 MedDRA and Product Labelling: Best Practices - 16 March 2005

Purpose: The purpose of this BRP was to consider a set of general recommendations on how MedDRA-coded data should be used in biopharmaceutical product labelling. These recommendations were to take into account the multiple purposes of product labelling and the characteristics of MedDRA.

Outcome: The MedDRA Management Board, at their meeting in May 2005, discussed the BRP3 recommendations on MedDRA and product labelling. To address the needs of subscribers and for further clarification of this complex issue, the Management Board decided to solicit input from at least one other MedDRA expert organisation. Ultimately, it was concluded that the development of MedDRA Labelling Entities (MLEs) would not go forward.

Documentation:

BRP 2 MedDRA Modifiers - 18 June 2004

Purpose: The Panel met to consider potential options for accommodating requests for and uses of “modified” MedDRA concepts (e.g., terms for conditions that are “aggravated”, “acute”, “post-operative”). The core of the MSSO’s proposal included the use of a “base” term (e.g., confusion) paired with a “modifier” (e.g., acute). A list of “modifier” terms would be maintained along with “base” terms. The MSSO’s proposal included a change to MedDRA files with the potential for significant impact on users and their systems (e.g., E2B). The potential benefits and risks of this approach were outlined in a background/proposal document.

Outcome: The MedDRA Management Board endorsed the Panel’s recommended approach. After collecting feedback on a set of posted proposed modified terms, the MSSO added the terms to MedDRA Version 9.1.

Documentation:

BRP 1 Scope and Specificity of MedDRA - 15 May 2003

Purpose: The purpose of this BRP was to provide the MedDRA Management Board with information to support the Board’s oversight and policy formation regarding MedDRA. At this particular meeting, the BRP was asked to review, discuss and make recommendations on MedDRA’s general scope and level of specificity.

Outcome:The recommendations were endorsed by the MedDRA Management Board and were implemented by the MSSO during MedDRA Version 7.0.

Documentation