As processes in drug development become increasingly digitalised, novel technologies that track progress of patient cohorts in real-time may allow for early intervention and improve data quality.
The clinical trial landscape is in crisis due to soaring costs, extended timelines and enrolment challenges, said Eslam Katab, global clinical development manager at Sandoz, at the recent Clinical Trials in Oncology (CTO) Europe 2025 conference in Munich.
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Biorce Europe’s clinical solutions director Matteo Talotta echoed this sentiment in another talk at the parallel conference, Clinical Trials in Rare Disease Europe 2025 meeting, which was taking place at the same venue. Speaking about clinical trials, he said: “they’re slower, they’re costlier, and they’re riskier than ever.”
Both speakers argued that AI could be leveraged to overcome these challenges.
Katab said: “AI is changing this situation and changing the way we are running clinical trials nowadays.”
He explained that AI can be integrated throughout the lifecycle of a clinical trial to simultaneously address multiple bottlenecks. One way of doing this is through the use of AI-based tools to remotely monitor patients.
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By GlobalDataKatab also noted that because most cancer patients receive treatment at facilities without clinical trial opportunities and existing trials have limited geographic reach, individuals who live far from academic medical centres – particularly minorities – are often unable to participate and thus remain significantly underrepresented.
He argued that this is an area where utilisation of novel technologies such as electronic patient reported outcomes (ePROs), and wearable biosensors can really make a difference. He said that such tools have already been established and are ready for implementation: “This is not something happening in the future, but it’s happening as of now.”
The impact of ePROs and biosensors
Patient preference and acceptability for ePROs is growing, said Katab. He explained that use of ePROs could mean fewer in-person visits, which helps reduce patient burden and thereby improves retention.
He said that patients “genuinely prefer the ePRO forms over the paper form”, adding that electronic monitoring is less error prone, faster to conduct and can substantially reduce clinical trial costs.
Furthermore, the use of ePROs can in some cases improve patient outcomes. Katab highlighted the observational CAPRI trial (NCT02828462), which investigated the impact of digital remote monitoring of patients receiving oral anticancer treatment. The study found that additional remote monitoring reduced days of hospitalisation and reduced treatment-related grade toxicities in patients.
Katab outlined how wearable biosensors can track a patient’s activity and function, such as sleep quality and step count, as well as treatment adherence or things such as diet or hydration tracking. Further, biosensors can measure physiological parameters such as heart rate variability, peripheral oxygen saturation (SpO₂) and blood pressure.
He said that such biosensor data can now be used to predict the likelihood of a safety signal occurring in a patient and thus allow for early intervention with preventative measures.
