Gli studi adattativi nella valutazione di efficacia dei farmaci

Translated title of the contribution: Adaptive studies to assess drug effectiveness

Paolo Bruzzi, Giuseppe Traversa

Research output: Contribution to journalArticlepeer-review

Abstract

The clinical development of drugs is based on a consolidated model that adopts, as a reference, the conduct of consecutive dose-finding and activity studies (the phases), up to the classical randomized controlled trials (RCTs), which are strictly regulated by a study protocol. This model is likely to be too rigid, since it cannot incorporate the information that gradually becomes available. To overcome, at least partly, this limited flexibility, so-called adaptive designs have been proposed: in these designs, it is possible to introduce changes and also to modify relevant aspects of a single design on the basis of results/information obtained in the study itself. This article presents the main characteristics of these designs and discusses the precautions to be taken into account in the application in clinical studies.

Translated title of the contributionAdaptive studies to assess drug effectiveness
Original languageItalian
Pages (from-to)251-253
Number of pages3
JournalEpidemiologia e prevenzione
Volume42
Issue number3-4
DOIs
Publication statusPublished - May 1 2018

ASJC Scopus subject areas

  • Epidemiology
  • Public Health, Environmental and Occupational Health

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