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Advisory Group to Recommend an Update to the Preamble to the IARC Monographs IARC Monographs on the Identification of Carcinogenic Hazards to Humans Report of the Advisory Group to Recommend an Update to the Preamble to the IARC Monographs Lyon, France September 2019 Report of the Advisory Group to Recommend an Update to the Preamble to the IARC Monographs Contents INTRODUCTION ......................................................................................................................... 1 Procedures and outcomes ........................................................................................................... 3 Advisory Group recommendations ............................................................................................ 5 GENERAL PRINCIPLES AND PROCEDURES ........................................................................ 5 Name of the Monographs series ................................................................................................ 5 Objective and scope ................................................................................................................... 6 Working procedures ................................................................................................................... 6 Conflicts of interest................................................................................................................. 6 Role of peer review in Monographs ....................................................................................... 8 SCIENTIFIC REVIEW AND EVALUATION ............................................................................ 8 Exposure characterization .......................................................................................................... 8 Evaluation of the quality of the exposure assessment in epidemiological studies ................. 8 Studies of cancer in humans....................................................................................................... 9 Importance of expert judgement ............................................................................................. 9 Study quality and informativeness ......................................................................................... 9 Studies of cancer in experimental animals ............................................................................... 10 Evidence summary and role within the overall evaluation ................................................... 10 Mechanistic evidence ............................................................................................................... 11 Importance and role within the overall evaluation ............................................................... 11 Classifications .......................................................................................................................... 12 Group 2 categories ................................................................................................................ 12 Group 4 category .................................................................................................................. 14 Instructions for Authors ........................................................................................................... 14 Lay summary and frequently asked questions ......................................................................... 15 REFERENCES ............................................................................................................................ 16 ANNEX 1. List of participants ....................................................................................................17 ANNEX 2. Public comments ...................................................................................................... 20 ANNEX 3. Scientific webinar agenda and list of participants .................................................. 216 ANNEX 4. Compilation of presenters' slides from the scientific webinar ............................... 219 Report of the Advisory Group to Recommend an Update to the Preamble to the IARC Monographs INTRODUCTION The Advisory Group to Recommend an Update to the Preamble to the IARC Monographs was convened at a time when significant shifts are occurring in the scientific evidence that contributes to the understanding of carcinogenicity, as well as in approaches to information gathering and evidence assessment and integration. Historically, for many agents, the IARC Monographs Working Groups have considered substantial bodies of epidemiological and animal bioassay research, along with evidence from mechanistic studies. The use of conventional animal bioassays is currently declining as alternative methods are developed and come into use. Simultaneously, studies of carcinogen mechanisms are increasing in availability and utility, and are contributing new types of evidence (e.g. from various –omics technologies, high-throughput screening systems, and in silico predictive methods that rely on structure–activity relationships). In addition, epidemiological research is available only for those agents for which exposures have taken place, studies have been conducted, and sufficient follow-up has occurred to provide useful results. For newer agents, epidemiological information may be unavailable or uninformative. However, epidemiological studies now include the collection of biological samples and the measurement of various biomarkers, and thus they offer enhanced assessment of exposures and outcomes, and the opportunity to bridge from laboratory findings on mechanisms to human populations. Epidemiological cohort studies are also evolving, to incorporate biobanks and large populations. All of these developments are relevant to the assessment of carcinogenic hazards. The carcinogenicity classifications provided by the IARC Monographs have broad implications. Therefore, these classifications have been carefully considered by the scientific community and other stakeholders, including the general public. Recently, a tendency has emerged to dismiss evidence-based findings in some sectors, particularly if the conclusions affect the interests of stakeholders. Given this changing climate, IARC should renew its commitment to ensuring that the processes used to develop the Monographs are fully transparent and rigorous, and potential conflicts of interest of Working Group members are fully revealed and addressed. 1 Report of the Advisory Group to Recommend an Update to the Preamble to the IARC Monographs IARC’s continued attention to scientific rigour and full transparency is essential to ensure that the conclusions of the Monographs will be fully defensible in the face of questioning, which has become inevitable for some types of agents. The Advisory Group noted that many recommendations for updates to the Preamble were aimed at increasing transparency about the processes that the IARC Monographs use, and particularly about the methods. Although IARC Working Groups have always conducted comprehensive reviews of evidence, the many advances in methods of systematic review provide a basis for enhancing transparency through more specific guidance to Working Group members. The IARC Monographs programme has embraced these systematic review methods, incorporating them into its procedures. The Advisory Group recommended updating the Preamble by specifying these procedures, for example, how reviews of the quality of the exposure assessment methods used can be integrated with results of studies of cancer in humans and with mechanistic data, how the principles of systematic review apply to IARC Monographs assessments, and how the rationale for expert judgement needs to be stated. The Advisory Group also recognized that there is a balance between transparency and specifying methods in the Preamble too rigidly. The Preamble is designed to accommodate flexibility as scientific methods evolve. The Instructions for Authors, which are updated more frequently than the Preamble is, describe how these methods are operationalized. The Advisory Group’s recommendations for updates to the Preamble also confirmed renewed commitments to transparency, including disclosure and publication of conflicts of interest, engagement with the public throughout the process, and limiting the use of data or studies to only those that can be made publicly available. Substantial revisions to the Preamble were recommended to reflect both the changing mix of scientific evidence considered by Monographs Working Groups – notably, that there will be a predominance of mechanistic evidence for some agents – and the evolution of review methods. The evolution of approaches for mechanistic research is reflected in the acknowledgement that three streams of evidence contribute to the classification of carcinogenicity: studies of cancer in humans, animal cancer bioassays, and mechanistic data. The key characteristics of carcinogens 2 Report of the Advisory Group to Recommend an Update to the Preamble to the IARC Monographs provide a framework for organizing mechanistic evidence and assessing its strength. The overall evaluation draws on the evidence from mechanistic data, animal cancer bioassays, and studies of cancer in humans in a more integrated fashion, rather than using the mechanistic findings only to “upgrade” or “downgrade” a preliminary classification based on the evidence from studies in humans and experimental animals, as previously. One consequence of the recommendations for updates to the Preamble is greater harmonization of the approaches to evidence evaluation across the four subgroups
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