Here you can access all the public outputs produced as part of the In Silico World project and made publicly and freely available to the in silico medicine research community.
Proximal femur bone mineral density in osteoporotic patients a review of placebo groups in clinical trials
The aim of this study was to perform a systematic review of Bone Mineral Density (BMD) loss measured in placebo groups of clinical trials for osteoporosis drug treatments. The data collected will be used to characterise bone loss in the populations typically recruited for interventional trials, and to simulate the disease progression in In Silico trials.
Reconsidering the Conceptualisation of Accuracy as a Principle of Data Processing
How can the principle of accuracy of data processing be conceptualised so as to contribute to mitigate possible harms to individuals (such as discrimination or misrepresentation) while guaranteeing their fundamental rights to privacy and data protection in the EU?
Surrogate model based sensitivity analysis of a one dimensional arterial pulse wave propagation model with correlated input
This study involved a methodology of two consecutive parts. The first part, the generation of the surrogate model, resulted in surrogate models that were able to accurately generate similar results as that of the one-dimensional pulse wave propagation model. In the second part, the sensitivity analysis was performed and the method, whilst assuming uncorrelated input parameters, was benchmarked against the established agPCE method by Quicken et al.
From the Virtual Physiological Human to the Human Digital Twin: a 20-year journey toward in silico medicine
Invited Lecture at the University of Bath (UK). The journey that brought us from the Virtual Physiological Human to the Digital Human Twin (now officially called Virtual Human Twin).
In Silico Medicine: Present and Future
Magistral lecture on In Silico Medicine at the Ph.D. Day 2022 Bioengineering and Medical Surgical Sciences of the Politecnico di Torino and of the University di Torino.
- what is In Silico Medicine
- can we predict life?
- what are the early results
- what are the open challenges
- What is the Virtual Human Twin
In Silico Medicine: Definition of Intended Learning Outcomes
Physics-based and/or data-driven computer modeling and simulation (CM&S) gain importance in cardio-vascular, musculoskeletal,immuno-therapeutical, neurological, and pharmaceutical applications. The goal of the In Silico World project is to lower barriers to the adoption of in Silico Trials (IST). This poster describes the process of how this project is defining Intended Learning Outcomes (ILO)for training and retraining of multiple stakeholder categories.
The use of Computer modelling & simulation in the regulatory process of medical devices
The annual congress of the French Society of Orthopedic and Traumatological Surgery (SOFTCOT) includes every year one special session organized by the European Federation of Orthopaedic Societies (EFORT). This year it was entitled: “EFORT ROUND TABLE: MODALITIES OF SURGICAL INNOVATION / MEDICAL & SCIENTIFIC RESEARCH REQUIREMENTS FOR THE CLINICAL INTRODUCTION OF ORTHOPEDIC JOINT REPLACEMENT DEVICES”. In a short presentations Prof. Viceconti informed the clinical audience of the role that modelling and simulations, and in particular clinical digital twins, will play in the regulatory approval of new orthopedic medical devices.
First report on Advanced solutions
The objective of WP2 is to address the first barrier B1:”Lack of advanced models: scarcityof predictive models advanced and robust enough to aspire a use in the reduction, refinement of replacement of the clinical trials required for the certification of newmedical products; challenges to support development; from blackbox to white box and back.”
The description of the final versions of Fast Accreditation Track applications and their movement towards WP4 to start the qualification advice (QA)processwith EMA, and first report on status of DAT applications is available in D2.1.
Report on initial validation data collections
The purpose of this deliverable is to identify, if possible, a general certification strategy that could be effective for all validation data collections.
Report on the certification of validation data.
This deliverable (report) focuses on the collection, curation, and publication of at least 7 data collections designed to provide validation to In Silico Trials solutions. The final goal is to provide reusable resources for validation that others can use for setting up their own in silico clinical trial and to provide validation collections for a set of specific applications.
Legal and ethical inventory
The present document “Legal and Ethical Inventory”, part of Work Package 9 ‘Ethical and Legal Framework’ of the In Silico World project, provides an overview of the core pieces of legislation and ethical principles that are relevant to the In Silico project, and thus, in silico trials.
First report on the qualification activities
This “First report on the qualification activities” aims at describing all the activities related to the qualification advice process for both FAT applications, from the preparations of the two Briefing Books, which describe in details the models and all the activities conducted to demonstrate the credibility of these solutions, to the first feedback from EMA, and all the necessary steps that precede the preparatory meeting with EMA commission. Preliminary exploitation investigation performed for both FAT applications are described as well.
Re-training and Education
The main goal of these processes is to train and educate a new workforce around development and use of In SilicoTrials technologies.
The ISW consortium plans to do this by defining, for each category of stakeholders, the intended learning outcomes (ILO).
The ABC method will then be applied to define, for each category, which course content is required to obtain each ILO. Next, for each content the optimal way of transferring knowledge and skills will be defined. This leads to a granulated course catalogue that is the basis for course offerings.
In Silico World Community of Practice
We believe that one effective way to accelerate adoption of in silico technologies is to establish a pre-competitive safe space where professionals working in academia, industry, regulators agencies, research hospitals, software houses, and contract research organisations can exchange information and establish best practices.
Requirements analysis report
One of the general objectives of the ISW Project concerns the development of an advanced yet easy-to-use simulaton environment to ensure repeatability, replicability and reproducibility of the researcher simulations and the implementation of an efficient strategy to access to the main computation and storage resources available in the Europe. To reach such objectves, the first step is the analysis of the different simulation architectures and the identification of the computational and storage needs of the different solutions developed by each partner; this requirement analysis is the object of the present deliverable.