Patent ID: 8219419
Filing Date: 2012-07-10
Classification: G16H

Abstract:
1. A method comprising: specifying, on an a priori basis, characteristics of a population of participants eligible to be included in a first phase of a clinical trial and characteristics of one or more subpopulations of participants of said population eligible to be included in a second phase of said clinical trial; identifying a group of potential participants for said first phase of said clinical trial as having said specified characteristics of said population; with respect to said first phase of said clinical trial: with respect to said second phase of said clinical trial: analyzing second phase response data of one or more of said participants in said second active treatment group and said second placebo group for response; and determining, using one or more processors, at least one measure of efficacy of said at least an active treatment, based at least in part on use of said analyzed first phase response data, use of said analyzed second phase response data, and use of an a priori null hypothesis, wherein said a priori null hypothesis is that: