EU-PEARL to share advances on Master Protocols design during DIA Global

EU-PEARL will actively participate in DIA Global 2022 which will be held in Chicago next 19-23 June. This important event for the life-sciences sector brings together representatives from industry, regulatory bodies, academia and patients to discuss scientific and medical innovations.

Project representatives will intervene during the session Statistical issues in “Master Protocols: Beyond Type I Error and Concurrent Controls” that will take place June 22nd at 1:45pm (CDT).  Benjamin Hofner (PEI), will deliver the speech “Master Protocols: Considerations from EU-PEARL and the European Regulatory Network”; Peter Mesenbrink (Novartis) will speak about “Challenges in the Execution of Platform Trials in the Pharmaceutical Industry and What we Have Learned from EU-PEARL and the COVID-19 Pandemic”. Martin Posch (MUW) will offer an academic update on this topic. The aims of this session, chaired by Alex Sverdlov (Novartis), are to:

  • Describe the main statistical challenges in platform trials
  • Discuss the role of clinical trial simulations when designing master protocols
  • Identify the key aspects when planning and analysing platform trials.

Madhavi Gidh-Jain (Sanofi) will offer the industry perspective during the session “New Tools for Creating Flexible and Sustainable Master Protocols” schedule for June 20th 4pm (CDT). During this session, participants will identify opportunities to utilize the IMI EU-PEARL integrated research platform framework, including a master protocol template, to set up a platform trial.

More information about the event here.