Six geese a-laying: CluePoints’ AI predictions for 2026

As our Christmas countdown continues, we move from reflections on the year just gone to what lies ahead. In the spirit of the six geese a-laying — a symbol of productivity, momentum and what’s to come — we turn to six forward-looking predictions for 2026.

Returning to the series is CluePoints, with Sophie Henderson, senior strategic consultant, sharing her hopes and expectations for how AI, analytics and risk-based approaches will continue to shape clinical development. From agentic AI to trust, transparency and smarter decision making, these predictions explore how the industry can turn technological potential into real-world impact in the year ahead.

What are your hopes and predictions for the industry in 2026?

AI offers the opportunity to further unlock the potential of RBQM and turn artificial intelligence into human intelligence. At CluePoints we already augment statistical models with, among other things, automated large language models (LLMs) to enhance areas like medical coding and medical review. In 2026, we expect to see Agentic AI increasingly used as an enabler to further operationalize analytics, summarize analysis results for deeper insights, make proactive decisions and resolve issues before they escalate. Agentic AI combines LLMs, machine learning (ML) and natural language processing (NLP) to pursue complex goals with limited supervision.

Sponsors and CROs looking to succeed in an increasingly pressurized environment need to think strategically about how to leverage the different AI models now available and combine them with advanced analytics. It’s about choosing the right tool for the job and closing the loop between analytics, operations, and outcomes. Just as we saw with RBQM, effective change management will be crucial for successful adoption. We need to be transparent about how AI is being used, educate stakeholders and build trust in the machine and validation process. Models should not just be black boxes – they should be tools stakeholders can genuinely trust and understand.

AI, combined with human expertise and regulator-backed risk-based approaches, offers the opportunity to transform clinical trials in 2026. By leveraging new technologies, we can deliver efficiencies, focus resources where they are most needed, succeed faster and turn data into positive outcomes in clinical development. This will not only result in treatments reaching the market faster – it will also empower informed decision making to improve patient outcomes worldwide.

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