At the 15th Annual Outsourcing in Clinical Trials (OCT) Europe conference, which took place between 29 and 30 April in Barcelona, Spain, industry experts delivered comprehensive insights, examined emerging trends and tackled regulatory and operational challenges of clinical trials nowadays.
Amid widespread geopolitical disruptions and drastic economic fluctuations such as tariffs, which are impacting supply chains across many industries, building strategic vendor partnerships and embracing new technologies in the biopharmaceutical sector is becoming more important than ever to navigate clinical trial challenges and drive operational success.
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Reflecting the evolving priorities in clinical trial research, strong collaborations, enhanced patient-centricity, AI, and agility were underlying themes discussed throughout the meeting over two days.
Patient-centric approaches should be prioritised
Providing context on the 2024 clinical trial landscape and lessons we can leverage from last year, Priya Ravisekara, senior analyst at GlobalData, said there was a slight drop in the number of ongoing trials compared to 2023, while the number of planned trials was 1.16 times lower. This likely reflected a post-pandemic adjustment/recalibration where sponsors are moving away from Covid-19 vaccines and therapeutics, and are now focused on resuming normal trial activity
Non-industry sponsors continued to take the lead in initiating trials, with 1.4 times more than industry sponsors, consistent with 2023 patterns, Ravisekara noted during a session at the conference. However, she added that non-industry sponsors dominated the landscape for trials that are ongoing and recruiting or planned.
Focusing on Europe, the impact of the EU Clinical Trials Regulation (CTR) was a widely discussed topic. During another panel at OCT Europe 2025, ARENSIA CEO Dr Claudia Hesselmann highlighted Moldova as a model for regulatory efficiency, citing its ten-day fast-track review process and proactive efforts to attract innovation.
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By GlobalDataDespite initiatives such as Accelerating Clinical Trials in the EU (ACT EU), sponsors still face an administrative burden and site contract problems when it comes to initiating trials. Experts advised companies to work closely with regulatory bodies to overcome such bureaucratic hurdles and also adopt patient-centric approaches at the earliest stages of clinical trials.
Throughout OCT Europe, the importance of ongoing communication with regulators, internal teams, vendors, and advocacy groups was highlighted. Additionally, as clinical trial regulations grow more complex, Dr Martine Dehlinger-Kremer, vice president of scientific affairs at ICON, stressed that early involvement of patients in trial designs is increasingly encouraged and even expected by regulators.
The significance of early Clinical Trials Information System (CTIS) submission to avoid compliance risks and the need for cross-functional coordination was also noted. Nevertheless, the expert consensus at the conference was that the new clinical trials under the ACT EU directive are preferred due to clearer timelines, which support improved trial planning.
AI as a tool to increase productivity in clinical trial delivery
A digital solution that was brought up by many experts as a way to optimise patient recruitment, retention, protocols, and real-time data monitoring was AI.
Piotr Maślak, director of operational data intelligence at AstraZeneca, held a session on how AI can be used to reach patients faster and more effectively in a dynamic environment.
The ability to employ AI tools that can use past data to create simulations for trial designs, reach target demographics, and predict retention risks, dropout rates, and treatment responses was among some of the potential AI applications that were discussed in depth during the conference sessions. Additionally, AI applications are also expected to support site selection, resource allocation forecasting, and supply chain management.
Forging successful and trustworthy partnerships
Another overarching theme discussed across multiple sessions at OCT Europe was maintaining strong and reliable partnerships. During a talk, experts discussed the challenges and strategies of small and mid-sized biopharma companies.
Since resources are limited in small to mid-sized biopharma companies, experts noted that even one dedicated trial operation leads individual can enhance trial execution. In an industry with a high turnover rate of key staff, which may lead to project disruptions and disengagement, they emphasised that maintaining and managing CROs and vendors, and implementing patient-centric approaches, remain some of the key challenges.
External partnerships can help with headcount gaps while promoting cross-functional collaboration, said Sarah Bischof, head of clinical developments at invIOs, a private biotech company developing next-generation cancer therapies. Additionally, being agile in adapting to structural and process changes is necessary, she added.
The need for agility in adapting to change is also applicable to vendor and partner relationships. Suzanne McNally, executive director in portfolio management at the CRO Parexel, talked about the situations when clinical trials need to be transitioned from one CRO to another while maintaining timelines and quality. Sponsors often hesitate to initiate trial transfers due to concerns about delays, complicated communication, and corporate objectives. Moreover, minimising the impact on patients and clinical sites in such cases is both crucial and challenging.
At a presentation at OCT Europe, McNally outlined the key elements of a transition, which typically involve strategic planning, preparation, due diligence, gap analysis, and finally, the execution phase. On the topic of transferring a trial without pausing it, she explained how companies should use two parallel teams—one to continue running the study and another to manage the transition. While transitions can be complex for ongoing studies, for safety monitoring and other crucial activities to remain uninterrupted, McNally emphasised that the handover must involve specialised workstreams covering areas such as regulatory affairs, data management, and clinical operations.
Enhancing clinical trial evidence with data
As clinical trials become increasingly complex, eyes were on the use of data—particularly of synthetic type—at OCT Europe.
Puja Myles, director of Clinical Practice Research Datalink (CPRD) at the UK’s MHRA, spoke on the potential for synthetic data to enhance evidence in clinical trials. While not currently being authorised for use, synthetic datasets created from algorithms could help boost ‘real’ data. In clinical trials, this can help facilitate data access, validation, and benchmarking, and help ‘fill in the gaps’ of missing data and undersampling.
The MHRA is researching to help clarify its position on the use of synthetic data in advancing treatments through pipelines.
“Sometimes you’ve done your clinical study, and despite your best efforts, your sample size is too small. And if in that situation, you need a rescue component, where it’s absolutely not feasible to go and collect more data, synthetic data could be an option,” said Myles.
Based on the MHRA’s research, Bayesian networks can generate robust models of relationships within datasets, Myles said. In instances where certain subgroups are underrepresented in data, employing synthetic data could give a more accurate sense of uncertainty analysis.
“[This is] not about replacing clinical trials, but how you can strengthen some of the evidence, especially if you have run into these logistics issues,” Myles said.
However, when companies eventually start to tap this approach in their clinical trial operations, the MHRA will consider what the synthetic data was trained on. Data bias is an ever-present issue in data application frameworks, and certain steps will need to be taken to ensure these are not amplified.
The term ‘synthetic’ also cropped up at the conference in the form of synthetic control arms. Despite the etymological similarities, synthetic control arms are different from synthetic data. Synthetic control arms use statistical methods to create a virtual control group based on observed data and historical data from a multitude of sources. Medidata’s statistics and regulatory science innovation SVP Ruthie Davi presented a session on the impact of synthetic control arms in clinical trials, especially in the case of rare diseases.
Davi explained that hybrid arms, where a control arm is supplemented with a synthetic control arm, which is of similar size to the investigational counterpart, are becoming a promising approach.
With hybrid arms, a numerical comparison between the prospect of a randomised control patient and the synthetic control patient can be used to test the presence of a bias, said Davi, which is advantageous.
“If those numerical estimates are similar, then you’re more reassured that the bias has been removed,” said Davi.
Rare disease research trends
Given ongoing regulatory changes in the US, discussions on rare disease clinical trials were of particular interest. One example was the rare pediatric disease priority voucher programme, a key framework to incentivise drug development in this area, which entered its sunsetting phase after US Congress failed to renew it in December 2024.
At the same time, amid ever-present calls to improve patient-centricity in trials, speakers discussed the importance of ‘aligning sponsor and patient’ views in trials. Once again, attention was drawn to difficulties in trial enrollment for rare disease studies, where speakers emphasised the role that technology—and in particular data—can play in streamlining trials. Historical data on rare diseases is also insufficient. Hybrid control arms, therefore, could provide a useful avenue to keep rare disease trials ticking along.
Davi added: “Assuming that you can identify the appropriate historical data, then the acceptability of a synthetic control in a rare disease is very high, and we’ve even seen cases where the FDA has approved products in a rare disease based on this.”
