The Alliance for Regenerative Medicine (ARM), the international advocacy organization representing the cell and gene therapy and broader advanced therapies sector, today published 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.Key Findings:
- Though the number of ATMP therapeutic developers based in Europe is approximately half of that based in North America, the number of clinical trials that have been initiated in Europe during the 2014-2018 period is only about a third of that in North America.
- During the same time period, the number of new clinical trials increased by 32% globally, 36% in North America, 28% in Asia, and less than 2% in Europe.
- There are proportionally more new gene therapy clinical trials (utilizing gene delivery, gene editing, and gene modified cell therapy technologies) in North America (71%) than in Europe (55%).
- There is considerable country-to-country variability in the number of clinical trials, speed of assessment, and time for approval of clinical trials in the different countries in Europe.
- In Europe, the UK, Spain, and France attracted the highest absolute number of new ATMP clinical trials (112, 102, and 101, respectively), followed by Germany and Italy (83 and 66, respectively).
- Within Europe, some individual countries have been particularly successful at attracting new clinical trials – with Belgium, Denmark, and Switzerland outperforming the USA and Canada in the number of new ATMP clinical trials per capita.
- ARM members said the most important criteria for selecting a clinical trial site and a country is the expertise and the skills of the clinical centers and healthcare professionals, followed by the speed of approval, the quality of the review, and the expertise of the regulatory authorities.
The fragmentation of regulatory bodies and ethical committees and the lack of harmonization on various aspects (e.g. donor testing requirements, patient information consent forms, contracting agreements) across the different countries may explain the complexity in starting new ATMP clinical trials in Europe, however, other reasons may also contribute, such as the lower levels of investment capital available in the region. The complexity of European GMO (genetically modified organisms) requirements and approval process may contribute to fewer gene therapy trials in Europe.