RL34 Subgroup Claim: When to Accept?
*Rajeshwari Sridhara, U.S. Food and Drug Administration 


Subgroup analyses are conducted routinely whether they are specified in the protocol or not. The results from such analyses become contentious particularly if the primary analysis in all randomized patients has not demonstrated efficacy. This roundtable will discuss the pros and cons of subgroup analyses when they were (1) planned vs. not planned, (2) observed in one study vs. multiple studies, and (3) in non-inferiority vs. superiority studies.