Hi Community,
Would you help me improve my understanding on how to correctly assign IMG as a secondary vs. exploratory objective? Throughout my career, I have supported studies where immunogenicity is an exploratory objective, we used a validated method and reported in the CSR, in order words, treated as we would a secondary objective. Recently, when questioned about this, I was not able to properly justify why it was not a secondary objective. In other cases, based on immunogenicity risk assessment, we have purposely placed immunogenicity under exploratory objectives because we do not intend to analyze unless we see an unexplained change in PK/safety. That aligns with this NIH reference (Endpoint (nih.gov)) see below. Also, for programs in life cycle management, exploratory makes sense, since there is so much data on IMG. For a FIH, can you think of why you would place under exploratory? Any other thoughts? Thanks so much for sharing your experiences.
From the NIH link: Exploratory endpoints may include clinically important events that are expected to occur too infrequently to show a treatment effect or endpoints that for other reasons are thought to be less likely to show an effect but are included to explore new hypotheses.
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Johanna Mora Ph.D.
Bristol-Myers Squibb
Princeton NJ
[email protected]------------------------------