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A benchmark for dose finding studies with continuous outcomes.

Pavel Mozgunov1, Thomas Jaki1, Xavier Paoletti2

  • 1Department of Mathematics and Statistics, Lancaster University, Bailrigg, Lancaster LA1 4YF, UK.

Biostatistics (Oxford, England)
|August 31, 2018
PubMed
Summary
This summary is machine-generated.

A new benchmark extends optimal design evaluation for dose finding studies with continuous outcomes. This tool accurately bounds performance, aiding clinical trial design in various settings.

Keywords:
Continuous endpointDose findingNon-parametric optimal designPhase IPhase I/II

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Area of Science:

  • Biostatistics
  • Clinical Trial Design
  • Pharmacometrics

Background:

  • Optimal benchmarks evaluate dose finding study designs, but existing methods are limited to binary endpoints.
  • There's a need for benchmarks applicable to continuous outcomes in dose finding studies.

Purpose of the Study:

  • Generalize the existing optimal benchmark to accommodate continuous and discrete outcomes.
  • Evaluate the performance of the generalized benchmark in Phase I and Phase I/II clinical trials.

Main Methods:

  • Re-interpreted and extended the O'Quigley and Cheung benchmarks.
  • Applied the generalized benchmark to simulated dose finding trials with continuous toxicity and efficacy endpoints.

Main Results:

  • The generalized benchmark accurately provides an upper bound on design performance for continuous endpoints.
  • Demonstrated applicability in Phase I (continuous toxicity) and Phase I/II (binary toxicity, continuous efficacy) trials.

Conclusions:

  • The proposed generalized benchmark is a powerful and versatile tool for evaluating dose finding study designs with various outcome types.
  • Facilitates more rigorous evaluation of clinical trial designs involving continuous data.