Patient and community engagement in clinical platform trials

Abstract

Platform trials measure the effects of multiple treatments against each other and against one control group simultaneously. Such approaches have the potential to revolutionize how clinical trials are conducted. Treatments can be developed faster, comparisons be made more easily, resources can be saved, and less participants are needed for trials. Within the Innovative Medicines Initiative (IMI) EU Patient Centric Clinical Trial Platform (EU PEARL) project, a public-private consortium aimed to build a framework for patient-centric platform trials together with patients and members of communities affected by four different conditions. The structured involvement of patient and community perspectives and input in research projects is increasingly viewed as a crucial and beneficial trial design factor. However, platform trials are complex endeavours, posing the question of how to involve patients and communities meaningfully. In this paper, we present a repository for Patient and Community Engagement in Platform Trials (PaCEPT), how it was developed, and how it can be used. PaCEPT contains information on general patient and community engagement, which is applicable to platform trials, as well as materials specifically developed for platform trials. The repository can support patients and communities in understanding what platform trials are and how they can benefit them, so that they can make evidence-informed decisions about participating in a platform trial. Further, people interested in becoming actively involved as an advisor for platform trials can gain in-depth insights that can prepare them well for such a role. PaCEPT also features materials that can help researchers to learn about the benefits of patient and community engagement for trial design and execution, and how to approach and include this stakeholder group. We encourage researchers to make use of this resource and call for evaluations of the implementation of the developed materials and the repository as a whole.