EU-PEARL highlights in its 2nd GAM the global need for a new framework of platform trials 

The context of emergency generated by COVID-19 has not held back EU-PEARL’s Consortium in advancing towards the new paradigm of clinical trials. In fact, this pandemic has highlighted the need to develop a novel framework in the field of clinical research that can facilitate a more agile response to global health challenges. This was the focus of the keynote speech delivered by Dr Derek C. Angus, UPMC Chief Healthcare Innovation Officer, during the opening session of EU-PEARL’s second General Assembly Meeting last September.  

The meeting was due to take place last June in Vienna but due to the COVID-19 pandemic it was postponed until autumn and organised in a virtual format. Regardless of the physical distance, the event proved critical to share advances made by the different work packages and promote scientific debate amongst all Consortium members to foster progress on the development of the Integrated Research Platform (IRP) model and establish next steps.  

EU-PEARLs second GAM was held in several half-day sessions dedicated to general and specific topics. Dr Angus opened the event referring to the REMAPCAP COVID adaptive platform trial designDr. Angus advocated for an integrative approach in clinical care and research that strikes the optimal balance to treat patients as well as possible and learn as fast as possible” which therapies are most effective.  

high-level recap on the project achievements this last year, was followed by reports on expected outcomes in five key areas: data governance, legal framework, statistical methods, clinical networks and patient centricityA panel discussion with experts from different work packages closed the first session.  

Advances made by trial designs ispecific disease areas Major Depressive Disorder (MDD)Tuberculosis (TB), Non-Alcoholic Steatohepatitis (NASH)and Neurofibromatosis (NF)– took center stage during this GAM’s second session. The different teams got together to discuss relevant trial design elements and leverage each other’s learnings. 

A session to expound how the draft of the master protocol template is progressing took place on October 1stDuring the meeting, the team working on example protocols in MDD, TB, NASH and NF stressed the fact that special attention is being placed in ensuring that this template is generic enough to apply to any disease under investigation in a clinical trial 

The GAM also offered the opportunity to learn from other IMI initiatives such as PARADIGM. Mathieu BoudesEPF representative and project leader, and Karina Huberman from EATG and PARADIGM tool development leader, offered an overview of the resources developed by this Consortium to facilitate patient engagement 

The last session took placed October 7th and focused on the project’s future sustainability plan. It then moved to offer a recap oprevious sessions highlights. Finally Ann Van Dessel and Joan Genescà, project leader and coordinator respectively outlined the next steps for the year ahead: advance on the governance, interoperability and business sustainability of the upcoming IRP framework; refine the master protocol template and develop further operational aspects related to clinical networks and federated patient data; continue fostering dialogue with experts about clinical challenges posed by IRPs and seek agreement in consensus definitions; and last but not least, further patient involvement in the design of this new framework of platform trials.   

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