Trial optimization across multiple endpoints

Folks: I knew that 15 plus years of NMUSER messages in my inbox would pay-off someday................. I am asking for you help with a question from a non-US health authority for an upcoming meeting.....not really a NONMEM question, but more of a general modelng question. We have proposed some trial design and optimization work (comparing various trial durations, designs, etc) based on a primary endpoint (ADAS-cog) used universally in the longitudinal disease progression trials for this indication (mild to moderate AD). The health authority opinion is that the trial optimization results could be misleading, as they are based only on one endpoint, and other endpoints (including a co-primary) would need to be taken into account in the overall assesment. My questions are 1) Does anybody else want to go to the meeting in my place? 2) Assuming I get no positive responses to question 1 above, is anyone aware of any model base trial simulations and optimization activities that have utilized more than one endpoint simultaneously? Any that look at two endpoints and weight them in some sort of utility index, or any that just even look at two endpoints and compare the trial simulation results at the end? Much thanks, Brian Corrigan, PhD Pfizer Global Research and Development 50 Pequot Avenue New London, CT 06320 860-732-9189