A Cambridge MA based therapeutics company asked Alacrita to provide feedback on the Phase III protocol design for its lead drug, specifically from an EU payer perspective. Alacrita’s expert European payer consultants worked with the company to determine to what extent the protocol was likely to generate data European payers would be looking for. The consultants considered:
- 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, as this could be a source of uncertainty for payers
- Economic data being collected
For each issue identified, a severity flag was assigned (Major, Moderate, Minor) coupled with expert suggestions to overcome the issues. Alacrita better positioned the client to understand how it could a) improve the protocol to maximize the value of its asset in Europe, b) be better informed about which Europe specific clinical trials it should be planning in the future.