title: 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: Unité de Biostatistique, CRLC Val d'Aurelle - Paul Lamarque, 34298 Montpellier, France. caroline.mollevi@montpellier.unicancer.fr
authors: C
authors: C
authors: Bascoul-Mollevi
authors: A
authors: A
authors: Laplanche
authors: M C
authors: MC
authors: Le Deley
authors: A
authors: A
authors: Kramar
mesh_terms: D000970:Antineoplastic Agents / Q000627:therapeutic use; D002675:Child, Preschool; D003131:Combined Modality Therapy; D006801:Humans; D008962:Models, Theoretical; D017599:Neuroectodermal Tumors / Q000188:drug therapy / Q000601:surgery
chemical_list: D000970:Antineoplastic Agents