REGULATORY CHANGES IMPACT ON CLINICAL TRIALS – CTIS (CLINICAL TRIAL INFORMATION SYSTEM)

The regulatory landscape of clinical trials in the European Union (EU) has evolved significantly, transitioning from the Clinical Trials Directive (CTD) to the more harmonized Clinical Trials Regulation (CTR) and the establishment of the Clinical Trial Information System (CTIS). This review aims to explore the reasons behind these regulatory changes, the objectives they intend to achieve, and their impact on clinical trial operations across Europe. The introduction of CTIS represents a pivotal shift towards a centralized platform for clinical trial submissions, authorization, supervision, and public transparency, aiming to streamline processes, enhance participant safety, and ensure consistent application of regulatory standards across member states. However, despite its potential benefits, the implementation of CTIS has encountered considerable challenges, including technical system flaws, integration difficulties, operational bottlenecks, and resistance to organizational change. These hurdles underline the complexity of modernizing regulatory systems at a pan-European level. Documented and implementation experience discussed in this article illustrates both the tangible benefits of CTIS, such as improved data management and enhanced participant engagement, and its persistent operational shortcomings, including technical, procedural, and cross-country harmonisation challenges. In conclusion, although the journey towards full CTIS adoption has been met with obstacles, with continued stakeholder training, technological refinement, and cooperative regulatory harmonization, CTIS holds great promise for creating a more transparent, efficient, and participant-centred environment for clinical research within the EU. This transformation not only benefits researchers and regulators but also enhances public trust in clinical trial outcomes, laying a robust foundation for future advancements in medical research.