Depression, is a serious and potentially life-threatening condition affecting up to 1 in 6 adults at some point during their lifetime. While considerable efforts over the past 40 years have led to the introduction of safer and better tolerated pharmacological treatments, they only achieve sufficient symptom reductions in about 50% of the patients with this disabling condition. However, developing new drugs is very time consuming and expensive. New approaches to more quickly and more efficiently detect the most promising new drug candidates are therefore needed. To address this, the EU Patient-cEntric clinicAl tRial pLatforms project (EU-PEARL) is developing what is called an “integrated research platform” that provides a reusable infrastructure for screening, enrolling, and assessing/treatment of participants in a flexible and highly adaptive “platform trial”.
In the Interim Report on TRD/PRD master protocol and regulatory requirements, we present a draft of how we envision our “integrated research platform” for depression. Moreover, we have discussed this draft with the European Medicines Agency (EMA), the authority overseeing pharmaceuticals in the European Union. We present a summary of the advice we have received from EMA experts to ensure that the trial yields speedy results on the benefit of any new drug tested and maintains the highest ethical and safety standards. Moreover, we provide an outlook on how we intend to proceed as we are moving towards finalizing our project.
Read full report.