Regional Differences in Primary Endpoints and the Statistician's Role in Dealing with Them
*Lucy Shneyer, Schering Plough Research Institute 


Often regions across the world may vary in their opinion on what the primary endpoint should be for a given disease. For example in studies of asthma, the FDA prefers a primary efficacy endpoint of FEV1 while EMEA prefers PEFR. In drug development programs, sponsors seek to conduct multinational Phase 2 and 3 studies to suit worldwide filings. If only a few studies are to be conducted, can these be designed in such a way as to satisfy all regulatory agencies? Can differing primary endpoints be handled through statistical analysis plans written to suit individual region preferences? On what basis then does the sponsor claim a study to be a success or failure? How does the statistician handle issues such as multiplicity in these situations? These and other questions can be discussed at this roundtable.