Task Force
CROM - Consumer Reported Outcome Measures Consortium - 2018
Objectives
To provide guidance on how to develop, validate, select, access and use consumer-reported outcome measures (CROM) to evaluate tobacco and nicotine-containing products for pre-market and post-market purposes:
- By reviewing existing information on measures
- By developing guidance on the development and validation of measures
- By creating a knowledge repository to store measures and facilitate identification and access
Through a cooperation platform involving tobacco industry and the guidance of academia and regulatory agency stakeholders
- Joining the CROM Task Force
- Overview of the CROM Task Force
- CROM Events
- CROM Presentations at External Events
Joining the CROM Task Force
CORESTA members who are interested in joining the CROM Task Force are encouraged to reach out to Christelle Chrea (christelle.chrea@pmi.com), Coordinator of the Task Force, to discuss willingness to get involved in the CROM consortium, as a funding or contributing member.
CORESTA Newsletter Issue 55 - Article on CROM Task Force
Overview of the CROM Task Force
Recently, novel tobacco products have been developed to reduce consumer exposure to harmful substances from smoking conventional tobacco products. For historical reasons, the Consumer Reported Outcome Measures (CROM) that have been developed to better understand tobacco users’ motivations, the subjective effects and behaviourm focused on cigarettes. This raises the question whether these measures are fit for purpose for novel tobacco and nicotine-containing products. Only very recently have these measures been developed in response to changed tobacco and nicotine delivery device use. These instruments have usually been developed in isolation and there is currently no assessment of the scientific merits of different instruments to further the development of international standards related to user experience of tobacco or nicotine exposure. There is a need for developing scientifically credible standards and research methodologies to support the assessment of these new tobacco products and satisfy regulators and the legal community.
A consortium approach, with contributions from manufacturers and related industry partners, is required to develop a scientific framework based on a shared vision:
- To collaborate with each other on scientific shift, beyond competition for market share
- To work with scientifically rigorous and well-respected partners to set up guidance to develop and validate new measures and research methods to achieve the strategic vision
- To use a core set of concepts and tools to facilitate sharing, comparing, replication of findings, and integration of data from multiple sources
To this end there was a consensus reached among members of the Product Use Behaviour Sub-Group, that a CROM Task Force should be formed within CORESTA.
The objectives of this Task Force, revised and approved by the Scientific Commission and the Board early 2020, are shown under the "Objectives" section above.
The consensus about the final objective, the process and structure of this consortium, short-term objectives (Phase 0) were submitted to and approved by the CORESTA executive bodies, i.e. the Scientific Commission and Board and are as follows:
- To clarify the goals of the Consortium, the research questions and the scope of work.
- To oversee the development of the CROM Consortium: governance, structure, budget & funding mechanisms and engagement with third parties.
- To prepare a workplan for the execution of future phases (1-4) for the working groups (WGs).
It is anticipated that 12 months will be required to complete this preparation phase and be ready to submit the objectives, timeline and budget for the phases 1-4 to CORESTA executive bodies.
- Phase 1: Review of Standards, Adaptation and Development of Guideline Documents
- Phase 2: Development of Repository (from Mapi Research Trust)
- Phase 3: Finalization through Public Review and Publication / Communication
- Phase 4: Long-term Management of the Repository
CROM Events
- Virtual CROM Symposium 2023 (held on 13 February 2023)
- Virtual CROM Workshop 2022 (2) (held on 29 September 2022)
- Virtual CROM Workshop 2022 (1) (held on 24 May 2022)
- Virtual CROM Symposium 2021 (held on 9 December 2021)
- Virtual CROM Symposium 2020 (held on 10 December 2020)
CROM Presentations at External Events
- Presentation:
"Consumer-reported outcome measure (CROM) guidelines with respect to descriptive-CROM for research on tobacco and nicotine-containing products"
Presented at the Tobacco Science Research Conference (TSRC) - New Orleans, Louisiana, USA - 11-14 September 2022 - Presentation:
"Human abuse liability assessment of tobacco and nicotine products: considerations to meet current regulatory recommendations"
Presented at the Tobacco Science Research Conference (TSRC) - Boston, Massachusetts, USA - 29 August - 1 September 2021 - Presentation:
"Development of Recommendations of Descriptive Consumer-Reported Outcome Measures (Descriptive-CROM) and Related Definitions in Tobacco and Nicotine Research"
Presented at the Tobacco Science Research Conference (TSRC) - Boston, Massachusetts, USA - 29 August - 1 September 2021 - Poster:
"Development of Consumer-Reported Outcome Measure (CROM) Best Practices and Guidelines for the Tobacco Industry with Respect to Psychometric CROM Using a Consortium-Based Approach: Methodology and Scope"
Presented at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Conference - Virtual - 17-20 May 2021 - Poster:
"Development of Consumer-Reported Outcome Measure (CROM) Best Practices and Guidelines for the Tobacco Industry with Respect to Psychometric CROM Using a Consortium-Based Approach: Methodology and Scope"
Presented at the Society for Research on Nicotine and Tobacco (SRNT) 27th Annual Meeting - Virtual - 24-27 February 2021 - Poster:
"A Consortium Approach for Consumer-Reported Outcome Measures for Assessing Tobacco and/or Nicotine-Containing Products"
Presented at the Society for Research on Nicotine and Tobacco (SRNT) 26th Annual Meeting - New Orleans, LA, USA - 11-14 March 2020
Updated November 2023