As the role of technology and digital tools in clinical trials expands, industry leaders are grappling with how to balance innovation with ethical and regulatory safeguards.
Speaking at the Outsourcing in Clinical Trials (OCT) DACH 2024 conference in Zurich, Switzerland on 29-30 October, a panel weighed in on the challenges of integrating new digital tools – ranging from AI to wearables – in ways that are both effective and ethical.
“There is a lot of awareness from the regulators now that this has to be moved forward,” said Eva Herrmann-Keiner, senior clinical operations manager at Swiss biotech Neurimmune, noting that regulatory bodies such as the US Food and Drug Administration (FDA) have formed working groups specifically to address AI in clinical trials.
There is cautious optimism about the anticipated guidelines. Herrmann-Keiner added: “There’s awareness, and they are working on it… but there’s still interpretability, question marks where I think we need a bit more information.”
The FDA has released several discussion papers, including those on AI/machine learning (ML) in drug development, and drug manufacturing.
In May 2024, Dr Khair ElZarrad, director of the Office of Medical Policy within FDA’s Center for Drug Evaluation and Research spoke on an FDA podcast where he said: “Internally, the FDA has established a steering committee to provide advice, and this is advice on the general use or feasibility of digital health technologies (DHTs) and the implementation of decentralised trials (DCTs).”
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By GlobalDataThis regulatory uncertainty intersects with ethical concerns over patient safety, data privacy, and equity. “We need to be aligned with the ethics when we’re speaking about technology and innovation,” said Francine Metelo Masega-A-Gulema, regional lead of WEIC DEICE at Pfizer.
Metelo questioned whether these innovations were reaching everyone who could benefit. “Maybe we can ask ourselves, are they accessible?… The people don’t have the same possibilities because we don’t all have the same access,” added Metelo, while emphasising the need for adequate infrastructure that can impact participation.
Moreover, new technologies must also address the needs of underrepresented communities who historically have faced barriers in accessing healthcare. “With this technology, will we be able to build trust with the community, especially the underrepresented?” Metelo asked, highlighting the importance of inclusive trial designs.
While AI can enhance clinical operations – automating processes like study planning or document generation that were previously done manually – Herrmann-Keiner emphasised that greater scrutiny is needed as technology’s reach moves closer to patients.
“We cannot simply be creative wherever we want,” she said. There’s more flexibility when using AI for operational tasks, she added, but the “closer we come to the patient,” the more essential it becomes to have clear regulatory boundaries.
As technology and regulatory frameworks evolve, the goal is to “uplift” and ensure “our mission is done in an equitable way because accessibility and equity are not the same”, concluded Metelo.
