Search

Different research communities have developed various approaches to assess the credibility of predictive models. Each approach usually works well for a specific type of model, and under some epistemic conditions that are normally satisfied within that specific research domain. Some regulatory agencies recently started to consider evidences of safety and efficacy on new medical products obtained using computer modelling and simulation (which is referred to as In Silico Trials); this has raised the attention in the computational medicine research community on the regulatory science aspects of this emerging discipline. But this poses a foundational problem: in the domain of biomedical research the use of computer modelling is relatively recent, without a widely accepted epistemic framing for model credibility. Also, because of the inherent complexity of living organisms, biomedical modellers tend to use a variety of modelling methods, sometimes mixing them in the solution of a single problem. In such context merely adopting credibility approaches developed within other research communities might not be appropriate. In this paper we propose a theoretical framing for assessing the credibility of a predictive models for In Silico Trials, which accounts for the epistemic specificity of this research field and is general enough to be used for different type of models.

The hip-spine relationship is a critical consideration in total hip arthroplasty (THA) procedures. While THA is generally successful in patient, complications such as instability and dislocation can arise. These issues are significantly influenced by the alignment of implant components and the overall balance of the spine and pelvis, known as spinopelvic balance. Patients with alteration of those parameters, in particular rigid spines, often due to fusion surgery, face a higher risk of THA complications, with an emphasis on complications in instability, impingement and dislocation. For these reasons, over the years, computer modelling and simulation techniques have been developed to support clinicians in the different steps of surgery. The aim of the current review is to present current knowledge on hip-spine relationship to serve as a common platform of discussion among clinicians and engineers. The offered overview aims to update the reader on the main critical aspects of the issue, from both a theoretical and practical perspective, and to be a valuable introductory tool for those approaching this problem for the first time. [ABSTRACT FROM AUTHOR]

The term “In Silico Trial” indicates the use of computer modelling and simulation to evaluate the safety and efficacy of a medical product, whether a drug, a medical device, a diagnostic product or an advanced therapy medicinal product. Predictive models are positioned as new methodologies for the development and the regulatory evaluation of medical products. New methodologies are qualified by regulators such as FDA and EMA through formal processes, where a first step is the definition of the Context of Use (CoU), which is a concise description of how the new methodology is intended to be used in the development and regulatory assessment process. As In Silico Trials are a disruptively innovative class of new methodologies, it is important to have a list of possible CoUs highlighting potential applications for the development of the relative regulatory science. This review paper presents the result of a consensus process that took place in the InSilicoWorld Community of Practice, an online forum for experts in in silico medicine. The experts involved identified 46 descriptions of possible CoUs which were organised into a candidate taxonomy of nine CoU categories. Examples of 31 CoUs were identified in the available literature; the remaining 15 should, for now, be considered speculative. [ABSTRACT FROM AUTHOR]