Virtual clinical trials could transform the development of new drugs

New cutting-edge research undertaken at the University of Leicester could revolutionize the way new drugs are developed and the way patients are cared for, through a pioneering new approach using virtual clinical trials.

Following a £500,000 Royal Academy of Engineering research funding award, Dr Himanshu Kaul, will expand research with his 'virtual asthma patient' to participate in virtual clinical trials, which could help make more accurate and timely predictions around which new drugs are successful and can offer benefits to patients.

Virtual clinical trials could also help doctors gain a better understanding of individual patients' disease progression, allowing them to tailor therapies to patients' individual needs and improve outcomes in a wider range of cases.

Currently, medications must meet a number of robust milestones over several years before human trials may begin, meaning that potentially life-saving drugs are often years away from patient use.

In a nutshell, more than 90% of drugs fail to reach the market. This is because we lack the capacity to predict the impact of drugs at the systems level, and this comes at a huge cost to pharmaceutical companies. In contrast, when aeronautical companies design a new plane, they run their design through rigorous mathematical models to predict how well the design will perform and optimize performance."

Dr Himanshu Kaul, Research Fellow, Royal Academy of Engineering

"There is no practical equivalent of this in the pharma industry, which will significantly drop the costs. My long-term research vision is to create software that will allow clinicians and pharmaceutical companies to predict how well a drug will perform in patients and offer a way to optimize its therapeutic efficacy."

Using agent-based modelling, Dr Kaul is collaborating with experts from the University of Leicester's Schools of Engineering and Mathematics and Department of Respiratory Sciences on his pioneering research project, titled 'The Lung Pharmacome'.

The project aims to produce a working in silico lung by 2024, with the ambition of conducting patient-specific 'virtual clinical trials' by 2025 at the earliest. The initial area of focus for the research will be lung diseases, specifically asthma and chronic obstructive pulmonary disease (COPD), with scientists and clinicians at the National Institute for Health Research (NIHR) Leicester Biomedical Research Centre's respiratory theme, based at Glenfield Hospital.

Dr Kaul continued: "Lung diseases are a major source of socio-economic burden globally. In the UK alone, lung diseases are the third-worst killers, affecting one in five people, and responsible for a death, on average, every five minutes.

"Outside of that, the cost to the economy given number of missed work days and in patient bed days is £11billion a year."

And identifying the right environment for his Fellowship was important to Dr Kaul, who added: "The University of Leicester was an obvious choice as the institution to carry out this research vision due to its strong clinical expertise, synergy between engineering and healthcare outcomes and a focus on precision medicine.

"Its clinical partners make it an exceptionally strong science complex with research efforts in engineering and biomedical sciences that extend from the molecular to the clinical scale.