Credible predictions for regulatory decision-making

detail from abstract by Zahrah ReshRegulators are charged with ensuring that manufactured products, from aircraft and nuclear power stations to cosmetics and vaccines, are safe.  The general public seeks certainty that these devices and the materials and chemicals they are made from will not harm them or the environment.  Technologists that design and manufacture these products know that absolute certainty is unattainable and near-certainty in unaffordable.  Hence, they attempt to deliver the service or product that society desires while ensuring that the risks are As Low As Reasonably Practical (ALARP).  The role of regulators is to independently assess the risks, make a judgment on their acceptability and thus decide whether the operation of a power station or distribution of a vaccine can go ahead.  These are difficult decisions with huge potential consequences – just think of the more than three hundred people killed in the two crashes of Boeing 737 Max airplanes or the 10,000 or so people affected by birth defects caused by the drug thalidomide.  Evidence presented to support applications for regulatory approval is largely based on physical tests, for example fatigue tests on an aircraft structure or toxicological tests using animals.  In some cases the physical tests might not be entirely representative of the real-life situation which can make it difficult to make decisions using the data, for instance a ground test on an airplane is not the same as a flight test and in many respects the animals used in toxicity testing are physiologically different to humans.  In addition, physical tests are expensive and time-consuming which both drives up the costs of seeking regulatory approval and slows down the translation of new innovative products to the market.  The almost ubiquitous use of computer-based simulations to support the research, development and design of manufactured products inevitably leads to their use in supporting regulatory applications.  This creates challenges for regulators who must judge the trustworthiness of predictions from these simulations.  [see ‘Fake facts & untrustworthy predictions‘ on December 4th, 2019]. It is standard practice for modellers to demonstrate the validity of their models; however, validation does not automatically lead to acceptance of predictions by decision-makers.  Acceptance is more closely related to scientific credibility.  I have been working across a number of disciplines on the scientific credibility of models including in engineering where multi-physics phenomena are important, such as hypersonic flight and fusion energy [see ‘Thought leadership in fusion energy‘ on October 9th, 2019], and in computational biology and toxicology [see ‘Hierarchical modelling in engineering and biology‘ on March 14th, 2018]. Working together with my collaborators in these disciplines, we have developed a common set of factors which underpin scientific credibility that are based on principles drawn from the literature on the philosophy of science and are designed to be both discipline-independent and method-agnostic [Patterson & Whelan, 2019; Patterson et al, 2021]. We hope that our cross-disciplinary approach will break down the subject-silos that have become established as different scientific communities have developed their own frameworks for validating models.  As mentioned above, the process of validation tends to be undertaken by model developers and, in some sense, belongs to them; whereas, credibility is not exclusive to the developer but is a trust that needs to be shared with a decision-maker who seeks to use the predictions to inform their decision [see ‘Credibility is in the eye of the beholder‘ on April 20th, 2016].  Trust requires a common knowledge base and understanding that is usually built through interactions.  We hope the credibility factors will provide a framework for these interactions as well as a structure for building a portfolio of evidence that demonstrates the reliability of a model. 


Patterson EA & Whelan MP, On the validation of variable fidelity multi-physics simulations, J. Sound & Vibration, 448:247-258, 2019.

Patterson EA, Whelan MP & Worth A, The role of validation in establishing the scientific credibility of predictive toxicology approaches intended for regulatory application, Computational Toxicology, 17: 100144, 2021.

Image: Extract from abstract by Zahrah Resh.

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