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2 results

  • Chapter 3 - Characteristics and Principles of Adaptive Trial Designs

  • from Part II - Basic Ingredients for Adaptive Trial Designs and Common Types
  • Jay J. H. Park, McMaster University, Ontario, Edward J. Mills, McMaster University, Ontario, J. Kyle Wathen, Cytel, Cambridge, Massachusetts
  • Book:
    Introduction to Adaptive Trial Designs and Master Protocols
    Published online:
    20 March 2023
    Print publication:
    06 April 2023, pp 21-27

  • Summary

    This chapter discusses the property and principles of adaptive trial designs. Adaptive trial designs refer to trial designs that offer pre-planned opportunities to modify the design of an ongoing trial based on accumulating trial data. Decisions for potential adaptations are made during the trial based on interim data, but flexibilities in adaptive trial designs are established and outlined in the study documents before any patient is recruited. For statistical planning, a simulation-guided approach is often used to evaluate the statistical properties of the design. It is generally required to demonstrate control of false positive rates for the regulatory, ethics, and funding bodies. Measures to mitigate and plan for operational bias and complexity in adaptive trial designs are needed.

  • EXPERIMENTAL DESIGN FOR DEPENDENT DATA

  • Part of
  • S. G. J. SENARATHNE
  • Journal:
    Bulletin of the Australian Mathematical Society / Volume 104 / Issue 1 / August 2021
    Published online by Cambridge University Press:
    09 November 2020, pp. 171-172
    Print publication:
    August 2021
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