Concept: Artificial Intelligence (AI) has been widely purported to be used throughout stages of the drug development process to identify novel targets, enhance understanding of disease mechanisms, and develop new biomarkers. AI, coupled with Machine Learning (ML), is reported to have the potential to transform pharmaceutical research and development over the coming decade, particularly in the area of Clinical Trials (CT).

Aim: The aim of this study is to examine the use of Artificial Intelligence and Machine Learning in Clinical Trials in the Irish Pharmaceuticals sector. Each new drug brought to the market by the Irish pharmaceutical sector typically costs millions of Euros and requires more than ten years of development. The expense and length are caused by the processes of identifying and testing of chemical entities that could be therapeutic. There may also be the fact that it has not been specifically studied or explored in the Irish context before.

Methods: The research method planned was to conduct online, semistructured interviews with 20 professionals in the Irish pharma sector. The methodology intended to collect mainly qualitative data to answer the research questions. Due to a poor response rate within the planned an available time-frame, the method was changed to data collection via an online, written, structured questionnaire. This change had a significant effect on the quantity and type of data collected and the time available for analysis reduced the reliability and validity of the data analysis planned, and hence findings and conclusions reached.

Findings: The study found that the use of AI/ML in clinical trials has the potential to reduce the duration of the drug development process, from the identification of novel targets to the development of new biomarkers. By automating certain aspects of the clinical trial process, AI/ML can also improve the accuracy and efficiency of data collection, analysis, and interpretation. This can lead to more effective and targeted drug development, ultimately resulting in faster delivery of end-drugs to patients at lower costs.

Conclusions: The study that investigates the impact of artificial intelligence and machine learning on the clinical trials of Irish pharmaceutical companies found that the use of AI/ML reduces the duration of the stages of the drug development process to identify novel targets, enhance understanding of disease mechanisms, and develop new biomarkers and enables delivery of end-drugs to patients more quickly and at lower costs