How to increase the number of European-based ATMP clinical trials?

How to increase the number of European-based ATMP clinical trials?

How to increase the number of European-based ATMP clinical trials?

The latest report published by the Alliance for Regenerative Medicine (ARM), the international advocacy organization representing the cell and gene therapy and broader advanced therapies sector, shows that Europe has become less competitive than other regions in attracting new advanced therapy medicinal products(ATMPs) clinical trials. This study 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.

Less than 2% increase in the number of ATMPS’ clinical trials initiated in Europe 

A total of  2.097 new clinical trials were initiated between January 2014 and June 2019. 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 during the 2014-2018 period 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% of all new trials) than in Europe (55% of all new trials). The report shows a considerable variability in the number of clinical trials, speed of assessment and time for approval of clinical trials in the different countries in Europe. Over the study period, UK (112), Spain (102) and France (101) attracted the highest absolute number of new ATMP clinical trials in Europe, followed by Germany (83) and Italy  (66). However, relative to their size, Belgium, Denmark, and Switzerland outperfom other European countries as well as the USA and Canada in the number of new ATMP clinical trials per capita.

ARM’s key recommandations

The main barriers dentified include 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. This may explain the complexity in starting new ATMP clinical trials in Europe. However  the ARM stresses the fact that lower levels of investment capital available in the region, complexity of European GMO requirements and approval process may contribute to fewer gene therapy trials in Europe.
Notwithstanding the quality of its clinical research centers, ARM stressed the fact that Europe could increase its attractiveness by improving timelines for approval of clinical trials and streamlining approval of multinational trials. The Clinical Trial Regulation  N°536/2014, which is expected to be implemented by the end of 2020, is aimed at facilitating clinical trials across the EU by streamlining the application procedure via a single entry point and harmonising the procure for assessment of clinical trial applications.  ARM sees this as an opportunity to  significantly improve approval timelines across Europe. The organization also asks  national competent authorities to allocate sufficient resources and to ensure an adequate level of expertise for the review of applications for ATMPs. The implementation of the above recommendations will contribute to maintaining a stronginnovation 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 alternativescan access these new transformative therapies at an early stage through participation in clinical trials.

The report has been 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,  Click here to get the full report