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JSM 2014 Session on Challenges

Tuesday, August 5, 2014 - 8:30am EDT
Dianne Finkelstein, PhD
Andrew Strahs, PhD
Ritesh Ramchandani
Marc Buyse
David Schoenfeld

A clinical trial may collect several outcomes that are to be used in deciding whether a new therapy is effective and tolerable for treating a chronic disease such as cancer. Often some of the outcomes (such as mortality) are censored. In oncology, the combined outcome of progression-free survival has been a standard primary outcome for some time, but there can be ambiguous results when survival benefit is not clear. In other diseases such as cardiology and neurology there has been interest in using global tests that combine multiple (possibly hierarchical) outcomes to assess new regimen. This session will discuss considerations for the design and interpretation a trial with multiple outcomes. Proposed non-parametric tests for a combined outcome will be considered. Specific trials will be discussed as illustration of the issues.

  1. Introduction: Issues in Multiple outcomes in clinical trails when they are ordered or simultaneous and possibly censored (Dianne Finkelstein, Mass General Hospital & Harvard University)

  2. Case Study on Analysis of Progression and Survival in a Trial with Treatment Crossover: the Aveo trial of Tivozanib in Renal Cancer (Andrew Strahs, PhD, Alnylam Inc)

  3. Global Tests for Multiple Outcomes in Chronic Disease Trials (Ritesh Ramchandani, Harvard School of Public Health)

  4. Comparing and Summarizing Multiple Outcomes in a Clinical Trial (Marc Buyse, CluePoints Inc, IDDI, Hasselt University, Belgium)

  5. Discussion: David Schoenfeld