PCNSDAC reviews and evaluates data for the treatment of neurologic diseases. Given the breadth of its mandate, PCNSDAC addresses a very wide and varied range of medical disorders and diseases. These include diagnostic agents and tests, chronic neurologic conditions, and sleep disorders.
With the many research efforts focused on movement disorders like multiple sclerosis and Parkinson's disease, there is a growing cross-referencing of this committee with other areas of expertise, particularly in diagnostic imaging and patient reported outcomes (PRO). In particular, PROs have grown in importance as they can be direct assessments of how a patient feels and functions.
While using PROs is on target with the FDA mandate for evaluation of approval, both the FDA and this committee struggle with the validation and usefulness of this important assessment tool. Clients need to pay particular attention to the development, validation, and utilization of these tools. They must also be particularly aware of the difficulties communicating PRO validity and clinical significance and avoid common communication pitfalls and errors with this committee.
ECG's experience reflects this wide range of indications. We have helped sponsors prepare for meetings involving neuroimaging and diagnostics, multiple sclerosis, and non-24 sleep-wake disorder affecting the blind. Each of these hearings presented new science, requiring complex assessments which the committee needed to understand and accept in order to support approval. We have also grappled numerous times with PRO circumstances that were key descriptions of effectiveness but lacked complete alignment with the PRO guidance of December 2009.
Please contact us via email or at +1-201-894-8200 to discuss your needs or to get further information about how we can support your upcoming PCNSDAC meeting.