PEARLDIVER pre kickoff meeting in Berlin

ECRIN attended the PEARLDIVER pre-kick-off meeting in Berlin on April 29. This meeting is building up to the official kick off later this year of this new platform trial for drug development and repurposing in major depressive disorder (MDD). Developed initially through the IHI funded EU-PEARL project this new platform trial will be set up in six European countries.

PEARLDIVER is a multi-arm platform trial designed to evaluate new therapeutic interventions for MDD in a more efficient and scalable way. A key feature of this trial is the utilisation of a master protocol using a single shared blinded control group, which enhances efficiency and reduces the number of participants required for control arms. It allows new candidate medicines (novel or repurposed medicines) to enter at any time. By sharing clinical trial protocols and infrastructure, PEARLDIVER aims to accelerate the development and validation of novel treatments while minimising costs and participant burden.

In this project, ECRIN will lead operational aspects together with the Sponsor and the Principal Investigator. Our lead CTU will play a pivotal role in managing various aspects of this clinical trial to ensure its success and compliance with regulatory and ethical standards. This includes supporting the regulatory approval process, coordination of monitoring activities, and data management as well as adapting strategies to address emerging challenges. In the participating countries (except the UK), the national ECRIN CTUs will provide local project management, support for regulatory approvals and monitoring. The overall coordination of ECRIN services will be done by our ECRIN EuCo in Germany: Neshat Chareh.