E219 ‘Pioneering AI in Clinical Trials’ with ICON’s Gerard Quinn

Today’s guest is Gerard Quinn, Vice President of Innovation and Informatics at ICON plc. With over 35 years of experience in clinical research services, ICON is at the forefront of leveraging artificial intelligence to revolutionise the clinical trial process. In this episode, Gerard shares invaluable insights into how AI is reshaping the landscape of clinical trials, emphasising the importance of trust, scalability and evidence of value.

Clinical trials have historically been a lengthy and complex process, primarily focused on testing the efficacy of new drugs. However, as Gerard points out, clinical trials are now an integral part of patient care, offering quicker access to innovative treatments for life-threatening illnesses. By integrating AI into these trials, organisations like ICON are significantly enhancing their speed, quality and efficiency.

Many businesses find themselves stuck in what Gerard describes as “pilot purgatory,” where ideas and pilots fail to scale into fully deployed solutions. He emphasises the importance of a structured triage process to evaluate ideas, assess business processes and to understand the data driving these processes. According to Gerard, having a solid business analysis team to work with the business and extract critical insights from data is key to driving successful AI projects.

One of the outcomes Gerard highlights is keeping a “human in the loop” during AI processes. Subject matter experts within the organisation review AI outcomes to ensure that decisions are informed and accurate. This collaboration not only enhances the decision-making process but also ensures that users trust the AI’s insights.

Gerard also acknowledges the challenges of AI, such as data accessibility, the complexity of AI projects and the need for leadership buy-in. Throughout the conversation, he stresses the significance of managing expectations and focusing on evidence of value. For AI to be effectively adopted and trusted, it must demonstrate tangible benefits and align with business goals.

One of ICON’s notable AI projects is the digitisation of clinical trial protocols. Traditionally, protocols were cumbersome and time-consuming documents that required extensive manual extraction of information. By leveraging AI, ICON reduce the process from multiple days to just four minutes, with human oversight ensuring trust in the AI’s output. This example not only highlights AI’s potential to transform processes but also underscores the cultural change required for successful AI integration.

As AI continues to evolve, organisations must remain vigilant about governance and transparency. With regulations like the EU AI Act coming into play, Gerard emphasises the importance of understanding the AI models and their outcomes. Organizations should proactively build a body of evidence to support their AI initiatives, following clear processes for documentation and validation.

Gerard’s insights provide a valuable roadmap for companies looking to harness AI’s capabilities in clinical research. By focusing on trust, evidence of value and collaborative innovation, businesses can unlock AI’s potential to improve patient care and streamline clinical trials. As the AI landscape continues to expand, organisations that prioritize transparency, governance and user engagement will be better positioned to succeed in this transformative era.