CROM - Consumer Reported Outcome Measures Consortium - 2018
- To develop a CROM approach for tobacco and nicotine products under the guidance of industry, academia and regulatory agency stakeholders.
- To adopt validation guidelines for CROM for use in the assessment of products with reduced risk potential.
- To create a repository of existing and new CROM instruments outlining measurement and validation approaches.
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 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 anticipate 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