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A New Scoring Method for Ordering Components within the Composite Endpoint in Oncology Trials

Abstract Number:

2182 

Submission Type:

Contributed Abstract 

Contributed Abstract Type:

Paper 

Participants:

Peiwen Yu (1), Ling Shi (2), Edward Valachovic (1), Victoria Lazariu (1)

Institutions:

(1) University at Albany, Department of Epidemiology & Biostatistics, N/A, (2) University of Massachusetts Boston, Department of Nursing, N/A

Co-Author(s):

Ling Shi  
University of Massachusetts Boston, Department of Nursing
Edward Valachovic  
University at Albany, Department of Epidemiology & Biostatistics
Victoria Lazariu  
University at Albany, Department of Epidemiology & Biostatistics

First Author:

Peiwen Yu  
University at Albany, Department of Epidemiology & Biostatistics

Presenting Author:

Peiwen Yu  
N/A

Abstract Text:

In clinical trials, patient-reported outcomes (PRO), encompassing multiple scales, have been widely used in measuring patients' quality of life, especially in oncology trials. The generalized pairwise comparison (GPC) combines the primary endpoint (e.g., overall survival) and PRO as the composite endpoint to assess the treatment effect. The prioritized GPC method requires a well-defined hierarchical order for each component within the composite endpoint. However, establishing a clear ranking order for each PRO scale is challenging. Non-prioritized GPC methods treat all components equally, thereby diminishing the importance of the primary endpoint. In response, we propose a semi-prioritized method that avoids the need for a strict order of PRO scales while simultaneously preserving the importance of the primary endpoint. We redefined the scoring algorithm, utilizing all endpoints observed in a trial to estimate the composite treatment effect, with particular emphasis on the primary endpoint. We conducted comprehensive simulation studies to assess the limitations of existing methods and applied all tests to data from an oncology trial.

Keywords:

Generalized Pairwise Comparison |Composite Endpoint|Patient-Reported Outcomes |Oncology Trials | |

Sponsors:

Biopharmaceutical Section

Tracks:

Statistical issues specific to therapeutic areas

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