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Novel diagnostic and therapeutic radiopharmaceuticals are increasingly becoming a central part of personalized medicine. Continued innovation in the development of new radiopharmaceuticals is key to sustained growth and advancement of…

Biomolecules · Quantitative Biology 2021-08-06 Bahar Ataeinia , Pedram Heidari

Randomized clinical trials, while often viewed as the highest evidentiary bar by which to judge the quality of a medical intervention, are far from perfect. In silico imaging trials are computational studies that seek to ascertain the…

Artificial Intelligence · Computer Science 2026-05-05 A Badano , M Lago , E Sizikova , JG Delfino , S Guan , MA Anastasio , B Sahiner

Clinical trials are pivotal for developing new medical treatments but typically carry risks such as patient mortality and enrollment failure that waste immense efforts spanning over a decade. Applying artificial intelligence (AI) to predict…

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.…

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…

In this chapter, we reflect on the use of Artificial Intelligence (AI) and its acceptance in clinical environments. We develop a general view of hindrances for clinical acceptance in the form of a pipeline model combining AI and clinical…

Computers and Society · Computer Science 2021-03-02 Jens Schneider , Marco Agus

Artificial Intelligence (AI) and Machine-Learning (ML) models have been increasingly used in medical products, such as medical device software. General considerations on the statistical aspects for the evaluation of AI/ML-enabled medical…

Methodology · Statistics 2023-03-10 Feiming Chen , Hong Laura Lu , Arianna Simonetti

The integration of artificial intelligence [AI] into clinical trials has revolutionized the process of drug development and personalized medicine. Among these advancements, deep learning and predictive modelling have emerged as…

Machine Learning · Computer Science 2024-12-11 Sydney Anuyah , Mallika K Singh , Hope Nyavor

Clinical trials are an indispensable part of the drug development process, bridging the gap between basic research and clinical application. During the development of new drugs, clinical trials are used not only to evaluate the safety and…

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…

Artificial Intelligence · Computer Science 2021-06-22 Stefano Sinisi , Vadim Alimguzhin , Toni Mancini , Enrico Tronci , Federico Mari , Brigitte Leeners

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.…

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…

Quantitative Methods · Quantitative Biology 2019-10-25 Marco Viceconti , Miguel A. Juárez , Cristina Curreli , Marzio Pennisi , Giulia Russo , Francesco Pappalardo

The discussions around Artificial Intelligence (AI) and medical imaging are centered around the success of deep learning algorithms. As new algorithms enter the market, it is important for practicing radiologists to understand the pitfalls…

Image and Video Processing · Electrical Eng. & Systems 2022-11-28 Rishi Gadepally , Andrew Gomella , Eric Gingold , Paras Lakhani

Artificial intelligence (AI) holds great promise for supporting clinical trials, from patient recruitment and endpoint assessment to treatment response prediction. However, deploying AI without safeguards poses significant risks,…

Machine Learning · Computer Science 2025-10-09 Yao Chen , David Ohlssen , Aimee Readie , Gregory Ligozio , Ruvie Martin , Thibaud Coroller

In the context of clinical research, computational models have received increasing attention over the past decades. In this systematic review, we aimed to provide an overview of the role of so-called in silico clinical trials (ISCTs) in…

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…

Computational Engineering, Finance, and Science · Computer Science 2025-03-06 Ruben Doste , Julia Camps , Zhinuo Jenny Wang , Lucas Arantes Berg , Maxx Holmes , Hannah Smith , Marcel Beetz , Lei Li , Abhirup Banerjee , Vicente Grau , Blanca Rodriguez

Clinical trials are conducted to test the effectiveness and safety of potential drugs in humans for regulatory approval. Machine learning (ML) has recently emerged as a new tool to assist in clinical trials. Despite this progress, there…

Artificial Intelligence · Computer Science 2023-10-06 Zifeng Wang , Brandon Theodorou , Tianfan Fu , Cao Xiao , Jimeng Sun

Artificial Intelligence (AI) and Machine Learning (ML) have significantly impacted various industries, including software development. Software testing, a crucial part of the software development lifecycle (SDLC), ensures the quality and…

Software Engineering · Computer Science 2024-09-05 Ahmed Ramadan , Husam Yasin , Burhan Pektas

Applications of artificial intelligence (AI) in drug development continue to increase at a rapid pace. Regulatory authorities have provided increasingly clear perspectives on the use of AI in regulated applications, including recent draft…

Applications · Statistics 2026-05-25 Aaron M. Smith , Tala Fakhouri , Run Zhuang , Jonathan R. Walsh

The development of automated experimental facilities and the digitization of experimental data have introduced numerous opportunities to radically advance chemical laboratories. As many laboratory tasks involve predicting and understanding…

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