Expert: David Scott - 12/5/2004

Question
David,
This may be a hard question -

What is the average size (both patients and number of assessment visits) for CNS Phase II trials, Phase III, and Phase IV trials (all CNS)?

Also, for every dollar the sponsor provides to the research sites, what percentage is for the psychometric assessments in CNS studies?

Thank you very much,
Pau Gilbert


Answer
This answer is based on personal experience, not case studies, nor actual data.  Please note, I have 10 years experience at a dedicated research center.

Phase II - 100 patients / 4 visits - 35% allocated to psychometric assessments.
Phase III - 350 patients / 10 visits - 45% allocated to psychometric assessments.
Phase IV - 500 patients / 6 visits - 70% allocated to psychometric assessments.