The EU-PEARL integrated platform trial for depression

Clinical trials are at the core of evidence based medicine. However, in psychiatry, the trials conducted often fail to inform clinical practice because many are underpowered.

Moreover, the number of new regulatory approvals in psychiatry has consistently lagged behind other areas of medicine, such as oncology, infectious diseases, or neurology.

Treatments are usually evaluated in individual trials, with participants randomized to the intervention or a control group, each trial conducted in a specific setting and requiring its own infrastructure, which is dismantled after completion of the trial. This approach is slow and not very efficient and limits comparability across trials.

In contrast, a platform trial uses a shared infrastructure for many treatments, a shared control group, and allows new treatments to be added over time.

This approach can increase the speed by which data on safety and efficacy can be obtained, reduce operational costs and participant burden, and increase statistical power. Platform trials have successfully been used in fields like oncology.

In this application, we are proposing a similar approach for the mental health field by building a reusable multinational infrastructure, operated by an open collaborative consortium, to run an integrated platform trial for new and repurposed treatments for depression.