A consortium approach for consumer-reported outcome measures for assessing tobacco and nicotine-containing products
The continuum of risk of tobacco products is generally accepted among public health authorities, where combustible products like cigarettes are the most risky and noncombustible products are at the lower end of the continuum. Adult smokers (AS) unable or unwilling to quit might benefit by switching to lower-risk tobacco and nicotine-containing products. Consumer-reported outcome measures (CROM) might help inform on the switching behaviors of AS from cigarettes to noncombustible tobacco products. CROM are self-reported observations that represent information intrinsic to the consumer, which cannot be obtained otherwise. To support regulatory decision-making on such products, there is a need for developing scientifically credible standards to ensure that CROM are valid and reliable. The CROM Consortium within the CORESTA framework seeks to establish best practices and guidelines for the integration of CROM into the tobacco regulatory process. The main objective of the consortium is to provide guidance on how to develop, validate, identify, access and use CROM to evaluate tobacco and nicotine-containing products for pre-market and post-market studies. To achieve this objective, a governance structure around specific working groups has been defined, with the tasks to: (i) review existing standards and guidelines on CROM and provide recommendations for standards that are fit-for-purpose; (ii) review, select and develop a knowledge repository for storing CROM and facilitating identification and access of the most appropriate CROM in a specific context of use; (iii) disseminate the work through communications and publications to foster a dialogue on the requirements for developing common terminology, standards, and best practices for CROM in tobacco and nicotine research; and (iv) use the Consortium as a collaborative platform between the tobacco industry, academia, and regulatory and public health stakeholders to enhance harmonization in CROM-related science.