title: A sequential procedure to test the progressive decrease of rare adverse events.
abstract: A program to construct the Rapid Sequential Test (R-ST), a sequential procedure to test the decrease of the rate of rare adverse events, is described. This sequential procedure is constructed with the Sequential Probability Ratio method. It relies on a model for the progressive decrease in the rate of adverse events from a given initial rate to a target rate, during a transition period. The program allows one to calculate the bounds of rejection of the R-ST, and to study its power under various types of decrease. It is shown that the R-ST gives a conclusion faster than standard sequential procedures for the same type I and II error, saving at least one quarter of the trials completed during the transition period. The use of the software to construct R-STs is discussed with respect to the specification of the model.
authors.affiliation: INSERM U 444, ISARS, Institut Fédératif Saint-Antoine de Recherche sur la Santé 27, Paris, France.
authors.forename: P Y
authors.initials: PY
authors.lastname: Boëlle
authors.forename: P
authors.initials: P
authors.lastname: Garnerin
authors.forename: A J
authors.initials: AJ
authors.lastname: Valleron
mesh_terms: D001803:Blood Transfusion / Q000706:statistics & numerical data; D003196:Computer Graphics; D006648:Histocompatibility; D006801:Humans; D008433:Mathematics; D019300:Medical Errors / Q000706:statistics & numerical data; D009010:Monte Carlo Method; D011336:Probability; D012984:Software; D065227:Transfusion Reaction