Online Program

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Thursday, September 13
Thu, Sep 13, 11:45 AM - 1:00 PM
Various Rooms
Roundtable Discussions

TL16: Planning Cardiovascular Clinical Trials with Biomarkers as Primary or Composite Endpoints for Regulatory Considerations (300621)

*CV Damaraju, Janssen R&D 
*Juliana Ianus, Janssen R&D 

Keywords: Cardiovascular, Composite endpoint, Biomarker, Risk prediction

Cardiovascular diseases (CVD) are the leading cause of morbidity and mortality in the United States. They lead to high-risk of recurrent events, morbidity, and mortality. Managing patients based solely on clinical assessment has its limitations. To identify and manage the “vulnerable” patients at risk for cardiovascular diseases, clinicians are increasingly relying on biomarkers. Biomarkers are objectively measured and evaluated and act as good indicators of underlying biological/pathogenic processes as well as pharmacological responses to therapeutic interventions. Biomarkers linking diabetes to CVD, heart failure (HF) and chronic kidney disease (CKD) have complex mechanisms, and are part of a n ongoing debate when designing trials, especially the construction of the primary or composite endpoints.

In this roundtable luncheon, we will discuss two points of interest: • Selection of biomarkers as endpoints in risk prediction of cardiovascular outcomes. • Analysis strategy for biomarkers as primary or composite endpoints for regulatory considerations.