Imaging-based eligibility, safety & efficacy endpoints play an increasingly crucial role in the context of CNS clinical trials. The situation has dramatically changed over the past decade in terms of expectations of the regulatory agencies and sponsors, level of complexity of CNS trials and the criticality of using advanced image processing algorithms to enable quantitative assessments in a highly regulated environment.
MRI endpoints now play a key role in the overall design of CNS clinical trials. The introduction of quantitative efficacy parameters such as longitudinal brain & hippocampal atrophy has added tremendous value in terms of enabling supportive data clearing the path to faster registrations.
The following items are presented to cover the key activities in CNS clinical trials: