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A clinical trial is an essential step in drug development, which is often costly and time-consuming. In silico trials are clinical trials conducted digitally through simulation and modeling as an alternative to traditional clinical trials.…
In recent years, human in silico trials have gained significant traction as a powerful approach to evaluate the effects of drugs, clinical interventions, and medical devices. In silico trials not only minimise patient risks but also reduce…
In Silico Clinical Trials (ISTC), i.e., clinical experimental campaigns carried out by means of computer simulations, hold the promise to decrease time and cost for the safety and efficacy assessment of pharmacological treatments, reduce…
A key challenge for the development and deployment of artificial intelligence (AI) solutions in radiology is solving the associated data limitations. Obtaining sufficient and representative patient datasets with appropriate annotations may…
Since the turn of the millennium, computational modelling of biological systems has evolved remarkably and sees matured use spanning basic and clinical research. While the topic of the peri-millennial debate about the virtues and…
The introduction of computational models in cardiovascular sciences has been progressively bringing new and unique tools for the investigation of the physiopathology. Together with the dramatic improvement of imaging and measuring devices…
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.…
Artificial intelligence (AI) now enables automated interpretation of medical images for clinical use. However, AI's potential use for interventional images (versus those involved in triage or diagnosis), such as for guidance during surgery,…
During the last decades, medical observations and multiscale data concerning tumor growth are mounting. At the same time, contemporary imaging techniques well established in clinical practice, provide a variety of information on real-time,…
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…
The human-associated microbiome is closely tied to human health and is of substantial clinical interest. Metagenomics-based tools are emerging for clinical diagnostics, tracking the spread of diseases, and surveillance of potential…
With many advancements in in silico biology in recent years, the paramount challenge is to translate the accumulated knowledge into exciting industry partnerships and clinical applications. Achieving models that characterize the link of…
FDA has been promoting enrollment practices that could enhance the diversity of clinical trial populations, through broadening eligibility criteria. However, how to broaden eligibility remains a significant challenge. We propose an AI…
Current clinical decision-making in oncology relies on averages of large patient populations to both assess tumor status and treatment outcomes. However, cancers exhibit an inherent evolving heterogeneity that requires an individual…
Aim: provide a methodological framework for the process of clinical tests, clinical acceptance, and scientific assessment of algorithms and software based on the artificial intelligence (AI) technologies. Clinical tests are considered as a…
Clinical trials are pivotal in the drug discovery process to determine the safety and efficacy of a drug candidate. The high failure rates of these trials are attributed to deficiencies in clinical model development and protocol design.…
To generate evidence regarding the safety and efficacy of artificial intelligence (AI) enabled medical devices, AI models need to be evaluated on a diverse population of patient cases, some of which may not be readily available. We propose…
Adolescent idiopathic scoliosis (AIS), a prevalent spinal deformity, significantly affects individuals' health and quality of life. Conventional imaging techniques, such as X - rays, computed tomography (CT), and magnetic resonance imaging…
As a future trend of healthcare, personalized medicine tailors medical treatments to individual patients. It requires to identify a subset of patients with the best response to treatment. The subset can be defined by a biomarker (e.g.…
Clinical trials are indispensable for medical research and the development of new treatments. However, clinical trials often involve thousands of participants and can span several years to complete, with a high probability of failure during…