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Proposal 1186

Title of the Proposed Research

Using generalized pairwise comparisons to assess the benefit/risk balance of pazopanib vs sunitinib for patients with advanced or metastatic renal cell carcinoma

Lead Researcher

Marc Buyse

Affiliation

IDDI inc

Funding Source

None

Potential Conflicts of Interest

None

Data Sharing Agreement Date

16 February 2017

Lay Summary

Traditional statistical tests can be used to compare two groups of subjects in terms of simple outcomes, such as response to treatment, duration of survival, adverse events rate, quality of life, etc. The method proposed here fundamentally differs from such traditional tests in several important ways. In particular, it makes it possible to compare two samples in terms of several outcome measures simultaneously, as long as these outcome measures can be prioritized (Buyse 2010). The method might be used to perform an assessment of the benefit-risk balance of interventions in randomized trials (PĂ©ron 2015). Of note, generalized pairwise comparisons are equivalent to traditional tests for simple outcome measures. To help illustrate how this innovative method might improve randomized trials data analysis, we propose to use it on COMPARZ trial data.

Study Data Provided

Novartis-VEG108844: Study VEG108844, A study of Pazopanib versus Sunitinib in the Treatment of Subjects with Locally Advanced and/or Metastatic Renal Cell Carcinoma

Statistical Analysis Plan

Publication Citation

The publication citation will be added after the research is published.

Summary Results

Results summary or link will be posted when available.