Print  Close

SAS macros for group sequential designs for survival endpoint with non-proportional hazards

Abstract Number:

3833 

Submission Type:

Contributed Abstract 

Contributed Abstract Type:

Paper 

Participants:

Milind Phadnis (1)

Institutions:

(1) University of Kansas Medical Center, N/A

First Author:

Milind Phadnis  
University of Kansas Medical Center

Presenting Author:

Milind Phadnis  
University of Kansas Medical Center

Abstract Text:

Group sequential designs (GSD) allow sequential monitoring of efficacy and safety as part of interim testing in clinical trials. Although literature is well developed for GSD with continuous and binary endpoints, options are restrictive when dealing with time-to-event endpoints. Commercial software provides options for executing GSD only using the proportional hazards or with assumption of exponentially distributed survival time. We have developed a novel simulation-based GSD for the non-proportional hazards scenario utilizing the concept of Relative Time. We present two new SAS macros that can execute such GSDs – {i} with both efficacy and futility boundaries, {ii} with efficacy only boundary. Our SAS macros provide many advanced features – binding/non-binding futility rules, skipping for futility, flexible error spending, equal/non-equal spaced interim looks, and allow administrative censoring and dropouts. A user-friendly output (both numeric and graphic) displays sample size calculation and the efficacy/futility cut-off boundaries. The macros also generate three dimensional plots showing expected reduction in sample size when using GSD compared to usual fixed two-arm trials.

Keywords:

group sequential design|non-proportional hazards|SAS macro|time-to-event endpoint|sample size|Relative Time

Sponsors:

Biometrics Section

Tracks:

Survival Analysis

Can this be considered for alternate subtype?

Yes

Are you interested in volunteering to serve as a session chair?

Yes

I have read and understand that JSM participants must abide by the Participant Guidelines.

Yes

I understand that JSM participants must register and pay the appropriate registration fee by June 1, 2024. The registration fee is non-refundable.

I understand