Experts in Clinical Research in Neurosciences constitute the COA Group. Members are representatives of the different stakeholders that play a role in the design of innovative clinical trials, pharma industry, consultants, regulators, clinicians, and services providers companies. The representativity includes European countries, United States of America, Canada and Asian regions.
Clinical trials in neurosciences show a high percentage of negative trials when new drugs have to demonstrate efficacy. As experts in clinical neurosciences research, we acknowledge that this constitutes a serious challenge in the field, compared to other research areas, resulting in a low rate of drug discovery and a significant delay in treating disabling disorders in psychiatry or neurology efficiently.
From our view, the difficulty to prove efficacy for new treatments in clinical neurosciences is due not only to the complexity of CNS disorders but also to methodological limitations/challenges, including inadequate selection strategies of Clinical Outcomes and Assessment (COA) tools.
In view of this current situation, since 2018 the group has started activities addressed to promote good practices on the Clinical Outcomes field for early trials to increase the efficiency of translational science. After three years of activity the group has issued a COA guidance document that is regularly updated to offer a method for researchers.