Generative artificial intelligence (GenAI) has the potential to revolutionise clinical development – and certain key steps will help to unlock its full impact – according to a new report.
The ‘Intelligent Clinical Trials: Using Generative AI to Fast-Track Therapeutic Innovations‘ report, published by the World Economic Forum in collaboration with consultancy company ZS, considers the potential of GenAI in the clinical trials sector and assesses the primary obstacles to adoption.
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It states: “With smart investments and an enabling environment, GenAI can help development teams optimise trial design, improve trial feasibility and site selection, overhaul clinical operations, automate data analysis and speed up and errorproof regulatory submissions.”
The report identifies the five processes in clinical trials with the biggest potential for transformation through GenAI as clinical trial design, trial feasibility and site selection, patient recruitment and retention, data analysis and regulatory submission and review.
It calls clinical trial design the “holy grail”, noting that interviewees for the report identified the area as one of the best places to start utilising GenAI due to the potential for high return on investment (ROI).
The report’s authors predict that the technology will be employed to develop trial concepts and plans, as well as key statistical elements, based on its rapid analysis of previous trial data. They also anticipate that companies will eventually use GenAI to create digital and surrogate endpoints, as well as synthetic control arms and in silico trials.
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By GlobalDataRegulatory submission is viewed as “the low-hanging fruit” for the use of GenAI and is identified by interviewees as worthy of prioritisation. It is also suggested that GenAI could be used to convert data into different formats as needed, identify omissions and cross-reference documents to ensure regulatory compliance.
Beyond carrying out tasks that might otherwise not be possible, the report states that GenAI could offer rapid solutions at a fraction of the price of human labour.
“In the future, GenAI will automate many aspects of regulatory submission and review, including generating, organising and validating submission filings,” it says.
It adds: “GenAI can also feed predictive algorithms to predict the probability of regulatory success.”
GenAI in the clinical trials sector
By way of context, the report notes that the average cost of bringing a new treatment to market exceeds $2.5bn, with clinical trials accounting for around 40% of the total research budget for US pharmaceutical companies.
While the technology offers significant potential benefits for the section, though, there are clear barriers to its adoption that need to be addressed. The report identifies data fragmentation, inconsistent data quality and a regulatory vacuum as the three main issues.
Data fragmentation is an issue due to the “lack of industry consensus on what data is needed to advance clinical trials”, it says, while patchy data quality is a result of “inconsistent collection practices, incomplete datasets and human error feed”.
Meanwhile, the infancy of AI makes the regulatory vacuum particularly problematic, with different countries enforcing different rules, and some areas remaining ambiguous in their attitudes. The result is an ambiguous landscape, tricky to navigate for investors.
Yet the AI landscape is here to stay. GlobalData estimates the total AI market will be worth $1trn by 2030, up from $103bn in 2023, representing a compound annual growth rate of 39% across that period.
In its own recent ‘AI in Healthcare‘ report, GlobalData advised: “In the coming decade, the country that emerges on top in AI will lead the Fourth Industrial Revolution.”
GlobalData is Clinical Trials Arena‘s parent company.
