Some of the endpoints that are accepted by Regulators are insensitive in that they show little change in response to treatment or they take a long time to change.  As a result, studies performed using these endpoints are prolonged, large and expensive.  There is increasing interest in the Pharmaceutical industry to find other more sensitive endpoints. 

Data derived from a range of imaging modalities have been evaluated as potential measures of response.  However, these also need to show some correlation with the accepted endpoints.  We have helped to design and analyse studies to compare new endpoints with traditional measures.  We have provided the following:

• Definition of the ideal profile for the surrogate measures
• Association between new and traditional measures
• Use modeling and simulation to estimate sample sizes under different levels of association
• Full characterisation of the profile of the surrogate