JSM 2015 Preliminary Program

Online Program Home
My Program

Abstract Details

Activity Number: 372
Type: Contributed
Date/Time: Tuesday, August 11, 2015 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract #316529
Title: Sizing Clinical Trials When Comparing Two Interventions Using Two Time-to-Event Outcomes
Author(s): Tomoyuki Sugimoto* and Toshimitsu Hamasaki and Scott R. Evans and Takashi Sozu
Companies: Hirosaki University and National Cerebral and Cardiovascular Center and Harvard University and Kyoto University School of Public Health
Keywords: survival data ; full-competing ; semi-competing ; multiple co-primary ; Bivariate logrank statistic ; composite endpoint
Abstract:

Use of multiple endpoints creates challenges in the evaluation of power and the calculation of sample size during trial design. Clinical trials with multiple time-to-event outcomes are common in many disease areas including infectious disease, oncology, and cardiovascular disease. Sample size determination for time-to-event outcomes is more complex compared with continuous or binary outcomes. We discuss methods for calculating the power and sample size for randomized superiority clinical trials with two correlated time-to-event outcomes in the three independent or dependent censoring schemes: (i) where two events are non-fatal, (ii) when one event is fatal (semi-competing risk), and (iii) when both are fatal. We derive an asymptotic form of the bivariate logrank statistic in all three censoring schemes including when considering a composite endpoint consisting of fatal and non-fatal components. We investigate the behavior of power and the required sample sizes in clinical trials with the two inferential goals, where the trial is designed to evaluated if the intervention is superior (or noninferior) on:(i) all of the endpoints, and (ii) at least one endpoint (multiple primary).


Authors who are presenting talks have a * after their name.

Back to the full JSM 2015 program





For program information, contact the JSM Registration Department or phone (888) 231-3473.

For Professional Development information, contact the Education Department.

The views expressed here are those of the individual authors and not necessarily those of the JSM sponsors, their officers, or their staff.

2015 JSM Online Program Home