Work Package Structure

 

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 Click on the below Work Package titles to see a summary of the work

We will establish 3 standard Brighton Collaboration Working Groups based on the ad hoc Task Forces established during the WHO-Brighton Collaboration process in preparation of the WHO/Brighton Collaboration consultancy in Geneva, July 2014. One group is dedicated to prioritized outcomes in the mother and will focus on mother’s health, obstetric events during pregnancy, and delivery outcomes. One group is dedicated to the neonate ( 28 days of life ) and will include outcomes in the fetus. A third group will focus on the development of the glossary of enabling terms. The first two groups will form working groups comprised of a total of about 100 -200 volunteer subject matter experts to develop and revise the large number of case definitions simultaneously. These working groups will include representatives of public and private stakeholders and seek wide geographic distribution including LMIC. They will review the evidence from the pre-existing WHO-Brighton Collaboration landscape analysis and develop a set of interim case definitions according to the Brighton Collaboration process and format (https://brightoncollaboration.org/public/what-we-do/setting-standards/case-definitions/process.html). These interim definitions will be submitted for peer review to the global Brighton Collaboration Reference Group consisting of 3000 volunteer professionals as well as the investigators of ongoing trials and key stakeholder organizations. Specific focus will be on applicability in LMIC. Comments of this consultation will be incorporated in the final version of the definitions to be published in the peer reviewed medical literature.

The work of this group will build on the enormous work done at the Enterprise Vocabulatory Services, National Cancer Institute also in collaboration with the National Children’s Study at NIH related to the establishment of ontologies, terminologies and disease concepts for the monitoring of drug and vaccine safety in pregnancy. It will utilize (and possibly improve) the UMLS system for terminology services and will draw on existing infrastructures for code mapping across disease code dictionaries. It will also leverage the extensive pharmacoepidemiological expertise specific to multinational observational studies and federated database research for the development of case identification algorithms at EMC. The groups will build on previous interaction between NIH, EMC and the Brighton Collaboration in the context of a European Commission funded project called Global Research in Pediatrics towards the finalization of WP 2 deliverables. The NIH has developed terminologies and ontologies for maternal, fetal, obstetric and neonatal outcomes in the frame of the national children’s study and a general terminology service. GAIA will build on this development and ensure compatibility with other terminologies by mapping and consensus formation. NIH will not be able to accept funding from the BCF and contribute in kind.

This work package will capitalize on an existing draft guideline for collection, analysis and presentation of data developed by the Brighton Collaboration for monitoring the safety of immunization in pregnancy. This will be tailored to the needs of this project and will be finalized based on feedback from investigators of ongoing studies and parallel projects. Based on the new case definitions and guidance document a data collection matrix will be developed outlining key variables to be collected in the different monitoring settings during the vaccine and program life cycle. The existing Automated Brighton Collaboration Case Classification tool (ABC tool) will be expanded to include the newly developed set of case definitions and guidelines for automated single case and batch classification by level of diagnostic certainty and to prompt the investigator on critical information to be collection (on follow-up) for a given case to meet a higher level of diagnostic certainty.

The work package will promote evaluation and implementation of the interim and finalized versions of the standards, guidelines and tools in parallel efforts. We will leverage the internationally recognized capacity of IABS to organizing scientific conferences and symposia on approaches to standardize assessment of biologicals by bringing together public and private stakeholders and working towards inclusion of these standards in regulatory frameworks. We provide advice and solicit feedback from investigators in ongoing studies and research consortia for potential improvement of case definitions. Finally, review and recommendation of the standards by key organizations will be sought by this working group.

This task will involve general project management at the operational levels. By the application of best management practices, and will ensure:

  • Work plan control and update, schedule control, implementation of corrective actions.
  • Assurance of timely submission of deliverables with appropriate quality levels.
  • Risk Management and promotion of synergy and efficiency throughout.
  • Cost control and budget management.
  • Contract and legal management, entailing also the management of the subcontracts and formalizing updates of the work plan, roles and resources assignment as needed.

CASE DEFINITIONS AND KEY OBSTETRIC AND NEONATAL OUTCOMES

WP Leader: Sonali Kochhar, GHC

We will establish 3 standard Brighton Collaboration Working Groups based on the ad hoc Task Forces established during the WHO-Brighton Collaboration process in preparation of the WHO/Brighton Collaboration consultancy in Geneva, July 2014. One group is dedicated to prioritized outcomes in the mother and will focus on mother’s health, obstetric events during pregnancy, and delivery outcomes. One group is dedicated to the neonate ( 28 days of life (and will include outcomes in the fetus. A third group will focus on the development of the glossary of enabling terms. The first two groups will form working groups comprised of a total of about 100 -200 volunteer subject matter experts to develop and revise the large number of case definitions simultaneously. These working groups will include representatives of public and private stakeholders and seek wide geographic distribution including LMIC. They will review the evidence from the pre-existing WHO-Brighton Collaboration landscape analysis and develop a set of interim case definitions according to the Brighton Collaboration process and format (https://brightoncollaboration.org/public/what-we-do/setting-standards/case-definitions/process.html). These interim definitions will be submitted for peer review to the global Brighton Collaboration Reference Group consisting of 3000 volunteer professionals as well as the investigators of ongoing trials and key stakeholder organizations. Specific focus will be on applicability in LMIC. Comments of this consultation will be incorporated in the final version of the definitions to be published in the peer reviewed medical literature.

SHARED TERMINOLOGY AND CODE MAPPING

WP Leader: Stephen Hirschfeld, NIH

The work of this group will build on the enormous work done at the Enterprise Vocabulatory Services, National Cancer Institute also in collaboration with the National Children’s Study at NIH related to the establishment of ontologies, terminologies and disease concepts for the monitoring of drug and vaccine safety in pregnancy. It will utilize (and possibly improve) the UMLS system for terminology services and will draw on existing infrastructures for code mapping across disease code dictionaries. It will also leverage the extensive pharmacoepidemiological expertise specific to multinational observational studies and federated database research for the development of case identification algorithms at EMC. The groups will build on previous interaction between NIH, EMC and the Brighton Collaboration in the context of a European Commission funded project called Global Research in Pediatrics towards the finalization of WP 2 deliverables. The NIH has developed terminologies and ontologies for maternal, fetal, obstetric and neonatal outcomes in the frame of the national children’s study and a general terminology service. GAIA will build on this development and ensure compatibility with other terminologies by mapping and consensus formation. NIH will not be able to accept funding from the BCF and contribute in kind.

SHARED TOOLS FOR HARMONIZED DATA COLLECTION

WP Leader: Paul Heath, SGUL

This work package will capitalize on an existing draft guideline for collection, analysis and presentation of data developed by the Brighton Collaboration for monitoring the safety of immunization in pregnancy. This will be tailored to the needs of this project and will be finalized based on feedback from investigators of ongoing studies and parallel projects. Based on the new case definitions and guidance document a data collection matrix will be developed outlining key variables to be collected in the different monitoring settings during the vaccine and program life cycle. The existing Automated Brighton Collaboration Case Classification tool (ABC tool) will be expanded to include the newly developed set of case definitions and guidelines for automated single case and batch classification by level of diagnostic certainty and to prompt the investigator on critical information to be collection (on follow-up) for a given case to meet a higher level of diagnostic certainty.

STANDARDS REVIEWED AND IMPLEMENTED

WP Leader: Jorgen Bauwens, BCF

The work package will promote evaluation and implementation of the interim and finalized versions of the standards, guidelines and tools in parallel efforts. We will leverage the internationally recognized capacity of IABS to organizing scientific conferences and symposia on approaches to standardize assessment of biologicals by bringing together public and private stakeholders and working towards inclusion of these standards in regulatory frameworks. We provide advice and solicit feedback from investigators in ongoing studies and research consortia for potential improvement of case definitions. Finally, review and recommendation of the standards by key organizations will be sought by this working group.

PROJECT COORDINATION AND MANAGEMENT

WP Leader: Angel Horado, SYNAPSE

This task will involve general project management at the operational levels. By the application of best management practices, and will ensure:

  • Work plan control and update, schedule control, implementation of corrective actions.
  • Assurance of timely submission of deliverables with appropriate quality levels.
  • Risk Management and promotion of synergy and efficiency throughout.
  • Cost control and budget management.
  • Contract and legal management, entailing also the management of the subcontracts and formalizing updates of the work plan, roles and resources assignment as needed.