Emilia Costa

Smith & Nephew PLC

AI's explosive growth in drug development—132 entries in 2021 compared to one in 2016—indicates a paradigm-shifting change. By 2024, CROs will drive ethical advancement in clinical research through responsible AI integration.

In recent times, there has been a notable increase in the application of artificial intelligence (AI) and machine learning (ML) in medication development. The big shift happened in 2021, when 132 entries used AI, compared to just one in 2016. This noteworthy increase is consistent with the expanding impact of generative AI technologies in the life sciences and anticipates a dramatic shift in medication development. As artificial intelligence becomes more widely used, the pharmaceutical innovation landscape is changing dramatically.

AI Awareness and Evolution

While AI is not a new concept, it has gained tremendous interest in the life sciences field. Historically used in target identification, lead optimisation, and companion diagnostics, the introduction of generative AI has democratised its application. This open technology, backed by large language models (LLMs), has raised awareness among legislators, regulators, and the general public, boosting faith in AI's capacity to alter medication discovery and development.

Understanding AI in Clinical Development

AI, which combines machine learning, natural language processing (NLP), and generative capabilities, is proving to be indispensable in drug discovery across three critical fields. For starters, AI allows quick access to contextualised information via Search-and-Retrieve, enhancing business processes through interactive apps. Second, large language models (LLMs) excel at developing fresh content, allowing medical writers to enhance and repurpose current literature while saving time. Finally, workflow automation involves the integration of LLMs in streamlining high-volume tasks, particularly in improving safety and accelerating pharmacovigilance case processing, while also providing critical support for literature reviews.

CROs Embrace the AI Journey

Contract research organisations (CROs) are at the forefront of implementing AI in clinical development. Significant investments in AI solutions to improve efficiency, promote productivity, and allow teams to focus on high-value activities have occurred in recent years. AI technologies are growing in the sector, leading to a dynamic and innovative environment.

AI Solutions and Roadmap

CROs are currently investigating AI solutions with the goal of adding value to clinical research. Foundational technologies, which are frequently built on generative AI models, are being used to address regular activities as well as to tackle more complicated challenges, such as study design optimisation. The industry's strategy involves the regular release of specialised solutions, demonstrating a commitment to leveraging AI's capabilities in programming, medical writing, site monitoring, and audit trail evaluation.

Responsible AI Implementation

CROs are emphasising responsible AI use by ensuring that all solutions support human decision-making through the use of a person-in-the-loop paradigm. The responsible development and deployment of AI solutions is governed by dedicated AI working groups, steering committees, and centres of excellence. Compliance with applicable laws and guidelines demonstrates a dedication to building credibility with partners, sponsors, regulators, and patients.

Ethical AI integration is a priority for CROs as they work to progress clinical research. A revolutionary period in technology and life sciences, this commitment highlights the industry's resolve to use AI for the benefit of global healthcare.