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Identifying the patient harms to include in an in silico clinical trial
Computer Methods and Programs in Biomedicine, 2023Clinical trials represent a crucial step in the development and approval of medical devices. These trials involve evaluating the safety and efficacy of the device in a controlled setting with human subjects. However, traditional clinical trials can be expensive, time-consuming, and ethically challenging.
Philippe Favre, Jeff Bischoff
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In-Silico Clinical Trials as a New Paradigm in Medicine
2020 9th Mediterranean Conference on Embedded Computing (MECO), 2020In silico clinical trial represents a new paradigm for development of new drug and medical device. In SILICOFCM project Familial Cardiomyopathy disease was modelled with comprehensive list of patient specific features such as genetic, biological, pharmacologic, clinical, imaging.
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Advancing in Silico Clinical Trials for Regulatory Adoption and Innovation
The evolution of information and communication technologies has affected all fields of science, including health sciences. However, the rate of technological innovation adoption by the healthcare sector has been historically slow, compared to other industrial sectors.
Georgia S Karanasiou +2 more
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A risk and credibility framework for in silico clinical trials of medical devices
Computer Methods and Programs in Biomedicine, 2023The use of in silico clinical trials (ISCTs) to generate clinically-relevant data on new medical devices is an emerging area of regulatory research. Interest in ISCTs stems from recognized challenges in acquiring sufficient clinical data and the continued maturation of in silico technologies.
Jeff Bischoff +2 more
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In Silico Clinical Trials for Cardiovascular Disease.
Journal of visualized experiments : JoVE, 2022The SILICOFCM project mainly aims to develop a computational platform for in silico clinical trials of familial cardiomyopathies (FCMs). The unique characteristic of the platform is the integration of patient-specific biological, genetic, and clinical imaging data.
Nenad, Filipovic +7 more
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In silico design of clinical trials: A method coming of age
Critical Care Medicine, 2004To determine the feasibility and potential usefulness of mathematical models in evaluating immunomodulatory strategies in clinical trials of severe sepsis.Mathematical modeling of immunomodulation in simulated patients.Computer laboratory.We introduce and evaluate the concept of conducting a randomized clinical trial in silico based on simulated ...
Gilles, Clermont +5 more
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Design and implementation of in silico clinical trial for Bioresorbable Vascular Scaffolds
2020 42nd Annual International Conference of the IEEE Engineering in Medicine & Biology Society (EMBC), 2020In the recent years, Bioresorbable Vascular Scaffolds (BVS) for the treatment of atherosclerosis have been introduced. InSilc is a cloud based in silico clinical trial (ISCT) platform for drug-eluting BVS. The platform integrates multidisciplinary and multiscale models predicting the BVS performance.
Georgia S. Karanasiou +11 more
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The case for AI-driven cancer clinical trials – The efficacy arm in silico
Biochimica et Biophysica Acta (BBA) - Reviews on Cancer, 2021Pharmaceutical agents in oncology currently have high attrition rates from early to late phase clinical trials. Recent advances in computational methods, notably causal artificial intelligence, and availability of rich clinico-genomic databases have made it possible to simulate the efficacy of cancer drug protocols in diverse patient populations, which
Likhitha, Kolla +4 more
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In-silico pre-clinical trials for implantable cardioverter defibrillators
2016 38th Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC), 2016Regulatory authorities require that the safety and efficacy of a new high-risk medical device be proven in a Clinical Trial (CT), in which the effects of the device on a group of patients are compared to the effects of the current standard of care. Phase III trials can run for several years, cost millions of dollars, and expose patients to an unproven ...
Zhihao Jiang +6 more
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