Sample size under the additive hazards model.

ABSTRACT:

Background

The additive hazards model can be easier to interpret and in some cases fits better than the proportional hazards model. However, sample size formulas for clinical trials with time to event outcomes are currently based on either the proportional hazards assumption or an assumption of constant hazards.

Aims

The goal is to provide sample size formulas for superiority and non-inferiority trials assuming an additive hazards model but no specific distribution, along with evaluations of the performance of the formulas.

Methods

Formulas are presented that determine the required sample size for a given scenario under the additive hazards model. Simulations are conducted to ensure that the formulas attain the desired power. For illustration, the non-inferiority samp

SUBMITTER: McDaniel LS 

PROVIDER: S-EPMC4785046 | biostudies-literature | 2016 Apr

REPOSITORIES: biostudies-literature