The aim of the EU Clinical Trials Regulation (CTR) is to harmonise the clinical trial regulation process across 27 countries and have an 106-day approval timeline, stated Dr. Martine Dehlinger-Kremer, vice president of Scientific Affairs at global contract research organisation (CRO) ICON. However, while discussing the impact of regulation on the clinical trial industry in Europe at the keynote panel of the 15th Annual Outsourcing in Clinical Trial Europe 2025 meeting, she acknowledged that there were some initial complexities when the platform enabling CTR, Clinical Trial Information System (CTIS), was implemented. Nonetheless, significant progress has been achieved, and continuous improvements are ongoing, she added.
While obtaining trial approvals, sponsors still face problems with site contracts, she said. Germany – amongst other countries – wants to implement a standard site contract template to avoid such issues. In the broader discussion around regulatory inefficiencies in Europe and the need to duplicate documentation, there is a question of whether a product-based dossier, rather than trial-specific one, can reduce administrative burden. Dehlinger-Kremer said it is suitable to use the common document within a clinical trial application—the Investigational Medicinal Product Dossier (IMPD)— across different trials with the same compound. However, the protocol and patient-facing materials must still be tailored to each individual trial. A single IMPD can support multiple trials using the same investigational product, but a fully unified documentation package across all studies would not be feasible, she added.
Dr. Ekaterina Dukokina, head of Clinical Trials at Eilean Therapeutics, a US-based small molecule oncology drug discovery company, shared her perspective on being a sponsor outside Europe after working closely with regulatory bodies from different regions. She said the regulatory body in Australia offers streamlined pathways for clinical trial approval, while the bureaucracy in the EU and US can be a major bottleneck. In the EU, auditing and obtaining a legal representative as a sponsor from outside Europe requires a lot of work, she said. Additionally, a lot of preparation is needed for pharmacovigilance studies in Europe, and she cautioned that sponsors need to be aware of that.
Earlier patient involvement in clinical trial designs
As the regulatory hurdles and requirements increase, clinical trial complexity is also growing. Andrzej Szandrach, Executive Director and Head of Study Management R&I at AstraZeneca, emphasised that it’s critical to keep close partnerships with regulatory and patient advocacy groups, and to use technology to simplify the protocol and focus on the patient while involving all stakeholders. Dukokina agreed that it is crucial to build the protocol around the patients and not the endpoint, and maintain an open communication with regulatory bodies, internal teams, and outside vendors to make a study successful. In the case of large global organisations, which are often far removed from the clinical and patient side, Szandrach highlighted that integrating patient insights is key to ensure their perspective is embedded in the trial design from the outset.
According to Dehlinger-Kremer, regulatory authorities are now emphasising patient involvement in trial designs more than ever, especially given requirements under evolving clinical trial regulations. For instance, when submitting a New Drug Application (NDA), the FDA now includes specific criteria to assess whether patient input has been integrated, she said. Doing so means that patient input not only meets regulatory expectations, but can, in turn, also help reduce the burden of participation and improve the efficiency of trials.
Involving patients from the start is essential as the goal is to ultimately address their needs, and excluding patient input early in the process risks undermining that relevance and the quality of trials.
At the same time, a growing trend toward the use of basket and umbrella trials has been observed. Such designs offer a broader approach in early-phase development before narrowing focus. Revati Tatake, Global Head of Pharma Research, Analysis and Competitive Intelligence at GlobalData and chair of this panel, asked whether the increasing popularity of these designs reflects a strategic approach to identifying efficacy across diverse populations and is a response to regulatory complexities encountered in traditional trial pathways.
Dukokina noted that sometimes bureaucratic delays lead to planned template contracts with clinical sites falling through. In her experience, for example, due to the very competitive nature of blood cancer trials, such setbacks limit the perceived benefits of these trial designs, affecting patient recruitment. “[A] patient-centric approach is the only way to ensure both compliance and meaningful recruitment, particularly in highly competitive indications like hematology,” she added. Separately, Szandrach noted that although basket and umbrella designs are traditionally used in oncology, they are being explored in respiratory disorders and immunology since some conditions in those areas have similar underlying mechanisms. These trial designs, in such cases, can make clinical programmes run quicker and more efficiently while giving maximum benefit to the patient.
Tatake added that, both from a drug development and pharmacoeconomic standpoint, developing an asset applicable to multiple diseases can be highly advantageous for life cycle management. With such non-traditional trial designs, once a Phase I trial is completed, the same drug may be transitioned into Phase II or II/III trials across various indications, streamlining development to support strategic expansion while reducing redundancy.
The 15th Annual Outsourcing in Clinical Trials Europe meeting took place in Barcelona on the 29-30 of April 2025.
