As EU-PEARL pushes forward to transform the way clinical trials are conducted and to improve and accelerate the drug development process, it becomes clear that placing the patient at the center of the processes for developing a common framework is critical.
The first publicly held EU-PEARL Patient and Community Engagement Day took place on 1 June 2022. The event was marked by an online workshop, addressing the benefits for patients, and the requirements for informed consent in platform trials.
The event fostered an insightful and in depth dialogue between patients, funders and researchers. To kick off the meeting, Cécile Spiertz (Senior Director, Head External Innovation, Clinical Trial Platforms, Janssen), presented a brief overview of the current state of standard clinical trials development and the subsequent challenges that derive from the current lengthy process, in terms of costs, competition and patient recruitment.
Concluding there’s a social need to develop an innovative efficient model for clinical trials to increase timely access to drugs, which complements classical clinical trials, Peter Mesenbrink, Ph.D. (Executive Director Biostatistics, Novartis Pharmaceuticals Corporation) introduced the audience to platform trials and the benefits they generate for participants, in terms of safer and more effective drug development, less strain on patient recruitment and an improved scientific framework for sharing outcomes and learnings. Platform trials are co-designed by and around patients, being thus more adaptable.
The second part of the workshop was dedicated to an interactive panel discussion on special considerations around informed consent in platform trials, moderated by Stephanie Seidel (TB Alliance).
The panelists brought varied views to the table: Dr. Francesca Schiavone focused on the research perspective, Claas Roehl (NF Patients United; EU PEARL PAG) and Dr. Stephan Dressler (EATG; EU PEARL PAG) spoke about the patient perspective, while Dr. Charles Jacob (Sacred Heart University) offered ethical insight. The panelists shared their experiences with methods and ways of providing informed consent to patients. While the needs for informed consent are similar to current trials, decisions need to be made around how much information to include to provide all of the essential details, without overwhelming participants.
Throughout the panel discussion, the idea of patient engagement was a recurring theme, underlining once more the importance of fully involving the participants and patients in co-designing platform clinical trials. While having informed consent and available information (with adjustable levels of complexity) is a key milestone in the development of platform clinical trials, the workshop reinforced the importance of bringing the conversation on patient engagement to researchers, regulators and funders, for shaping a comprehensive overview on informed consent in platform trials.
Stay tuned for further updates on the ways EU-PEARL is putting patients at the center.