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This FAQs section details frequently asked questions about the ICH M7 guidelines. For FAQs on Lhasa products, please refer to the relevant product area.
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Is it true that every prediction used by an expert should be either a clear positive or negative call and that a prediction such as “Probable” or “Plausible” is ambiguous?

This is not correct – the requirement is for a single overall call by an expert, but not that all the information used to come to that overall conclusion is simply true or false.  In fact, it is not possible for all evidence to be simply ascribed as true or false with complete certainty since we are dealing with predictions.  In such cases, an expert should be looking at the weight of evidence and supporting information in order to decide whether to accept or reject a prediction.  To support this, Derek produces a measure of confidence in the prediction.  Derek defines “probable” as meaning “there is at least one strong argument that the proposition is true and there are no arguments against it” and “plausible” as meaning “the weight of evidence supports the proposition”. In qualitative terms, “probable” is associated with greater confidence than “plausible”. “Equivocal” is defined as meaning that there is an equal weight of evidence for and against a proposition, and this is distinct from “open” which means that there is no evidence in support of or against a proposition.  This has been robustly demonstrated and published in Judson, P. N., Stalford, S. a., & Vessey, J. (2013). Assessing confidence in predictions made by knowledge-based systems. Toxicology Research2, 70–79. doi:10.1039/c2tx20037f

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