SAE: an R package for early stopping rules in clinical trials.

Abstract:

:In the case of an unexpected high frequency of serious adverse events (SAE), statistical methods are needed to help in the decision making process as to continuation of accrual to the trial. This paper describes an R package, named SAE that implements a method recently developed by defining stopping rules after each observed SAE. The package function control for excessive toxicity either during the trial at the observation of each SAE (function SAE) or during the planning phase of a clinical trial (function DESIGN). This description and the package documentation are complementary to help the users to apply the method. The main difficulty in the implementation of the method is the choice of a priori parameters. Data from an ongoing clinical trial are presented as an example to improve the understanding and the use of the package.

authors

Bascoul-Mollevi C,Laplanche A,Le Deley MC,Kramar A

doi

10.1016/j.cmpb.2011.05.005

subject

Has Abstract

pub_date

2011-11-01 00:00:00

pages

243-8

issue

2

eissn

0169-2607

issn

1872-7565

pii

S0169-2607(11)00120-9

journal_volume

104

pub_type

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