Challenge
A therapeutics company asked us to provide feedback on a Phase III protocol design for its lead drug, specifically providing an EU payer perspective.
Solution
Our expert payer consultants worked with the company to identify where the protocol was most likely to generate data that European payers would be looking for. The consultants considered the:
- choice of primary endpoint and how it would be measured
- secondary endpoints including the appropriate choice of health-related quality of life instrument
- disease definitions
- economic data collection
For each issue identified, a severity flag was assigned (major, moderate, minor) coupled with expert suggestions on how to reduce each issue. We better positioned the client to understand how it could improve the protocol to maximize the value of its asset in Europe and how it could be better informed on which Europe-specific clinical trials should be planned in the future.