Randomized discontinuation trials : utility and efficiency.
The randomized discontinuation trial (RDT) is a two-phase trial.
In phase I all patients are openly treated with the medication being evaluated.
In phase II, those who have responded are randomly assigned to continue the same treatment or switch to placebo.
Usually, non-compliers and « adverse reactors » identified in phase I are excluded from phase II.
To investigate the value of this design, we reviewed the advantages and limitations of discontinuation studies, and compared the RDT design to the classic randomized clinical trial design in terms of clinical utility and efficiency (sample size).
A computer model was used to study the efficiency of the two designs under a broad range of assumptions.
Mots-clés Pascal : Essai clinique, Méthodologie, Modèle, Randomisation, Arrêt traitement, Etude comparative, Simulation ordinateur, Homme, Taille échantillon, Analyse statistique
Mots-clés Pascal anglais : Clinical trial, Methodology, Models, Randomization, Withdrawal, Comparative study, Computer simulation, Human, Sample size, Statistical analysis
Notice produite par :
Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 93-0611670
Code Inist : 002B30A08. Création : 199406.