Conducting CNS trials during a public health emergency – Lessons learned from the COVID-19 pandemic: A joint ISCTM/ECNP working group consensus paper

A joint working group between the International Society of CNS Clinical Trials and Methodology (ISCTM) and the European College of Neuropsychopharmacology (ECNP) was formed in the latter part of 2020 to explore possible ways to mitigate the impact of Coronavirus disease-19 (COVID-19) in clinical trials while attempting to advance approaches and capabilities to bring new therapeutics to patients. The working group was tasked with developing guidelines for trial design modifications to assist sponsor companies in minimizing risks to data integrity, with a focus on regulatory, technological, operational, and methodological issues related to COVID-19. To facilitate focused and transferable recommendations, three disease categories were selected as examples to demonstrate the breadth of solutions implemented across CNS clinical trials, as well as ongoing challenges. The categories studied reflected the interests and expertise of the working group, and included neurodegenerative diseases and dementia, mental health disorders, and rare/pediatric diseases. Herein, we describe interim recommendations from the working group as well as priorities for future public health emergencies, to inform permanent adoption in CNS clinical trial development and conduct.