The Alliance for Regenerative Medicine Outlines Recommendations for Increasing the Number of European-Based ATMP Clinical Trials

The Alliance for Regenerative Medicine (ARM), the international advocacy organization representing the cell and gene therapy and broader advanced therapies sector, published on October 31st a report outlining the latest trends in clinical trials with advanced therapy medicinal products (ATMPs) based in Europe, and its recommendations for how to improve its competitiveness compared to other global regions. The report, developed following a comprehensive global analysis of all new clinical trials with cell and gene medicinal products initiated between January 2014 to June 2019 and via an online survey with ARM therapeutic developer member organizations, provides detailed insights on clinical trials, including the number, type of technology, phase of development or approval process, specifically within Europe and also compared to other regions in the world.

Previous work has shown that the European Clinical Trial Directive 2001/20/EC presented some shortcomings, particularly for trials carried out in several Member States, and was responsible for a decline in the number of clinical trials in the European Union. In view of the sharp increase of the number of ATMPs in development during the last few years, the Alliance for Regenerative Medicine, in this report, has characterized the attractiveness of Europe, including national disparities, for the clinical development of ATMPs, and trends over time compared to other regions.  The implementation of the above recommendations will contribute to maintaining a strong innovation base and important R&D investments in Europe but, most importantly, this will be critical to ensure that European patients with serious diseases and only few or no alternatives can access these new transformative therapies at an early stage through participation in clinical trials.

For further information, see the ARM website (

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